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Association of the European Self-Care Industry

AESGP

The Association of the European Self-Care Industry represents manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe.

Lobbying Activity

Meeting with Olivér Várhelyi (Commissioner)

3 Nov 2025 · Challenges face by the self-care sector

Self-care industry urges simplification of medical device regulations

6 Oct 2025
Topic — EU revision of medical device and in vitro diagnostic rules.
Message — The organization requests targeted reforms to simplify classification rules, reduce administrative burdens including reporting obligations, and enable digitalization. They emphasize reforms must maintain high standards for patient safety.123
Why — This would reduce compliance costs reaching millions per company portfolio.456
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Meeting with Olga Solomon (Head of Unit Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations and

3 Oct 2025 · The discussion focused on simplifying Annex II to foster innovation while aligning with ICH guidelines, with ideas for legacy products to gradually transition.

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

4 Sept 2025 · Revision of the EU Pharmaceutical Directive

Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

15 Jul 2025 · AESGP presented the association, and the portfolio of products covered.

Response to Critical Medicines Act

6 Jul 2025

In response to the ECs Proposal for Critical Medicines Act, AESGP would like to draw attention to the specific case of Non-Prescription Medicines (NPMs). There are more than 200 APIs, available without prescription in Europe, and over 4.000 different products. With a high number of NPM manufacturers offering medicines that contain the same APIs, there is effective competition and an abundance of therapeutic alternatives available for both individuals and healthcare professionals to treat the same condition. Because of the low risk of NPM shortages, only few European countries monitor these proactively. For example, in countries where such data is available, only 1% of medicine shortages in Belgium and under 5% in Spain involve medicines with NPM status. Consequentially, only 3 APIs on the Unions List of Critical Medicines (hydroxocobalamin, medicinal charcoal and caffeine) are NPMs. Europe's robust regulatory framework for NPMs has fostered one of the worlds most reliable supply chains. Globalisation benefits Europe, as its key NPM manufacturing sites supply products internationally. AESGP therefore welcomes targeted scope of the Regulation that applies principally to the critical medicinal products listed in the Union List. It is important that any proposal to extend the scope to NPM should be considered only as a long-term strategic option, especially as the Union List of Critical Medicines is updated annually, while manufacturing projectsespecially those involving infrastructure or technology upgradesrequire multi-year planning and investment. This mismatch creates uncertainty for companies considering strategic investments. AESGP calls for a multi-year eligibility window for projects once a product is listed, e.g., a 5 year grandfathering period during which a project remains eligible for strategic designation and support, even if the product is later removed from the Union List. Manufacturing sites may produce both critical and non-critical medicines. It is unclear whether only the lines producing Union List products would be eligible for support, or whether site-wide investments (e.g., energy efficiency, digital upgrades) can be supported if they benefit critical production indirectly. AESGP calls for a clarification that site-wide investments are eligible for support if they demonstrably enhance the resilience or capacity of critical medicine production, even if other lines produce non-critical products. Securing a well-functioning global supply chain of pharmaceuticals is a key in the European response to improve availability of medicines.The possibility of importing final products as well as materials while maintaining strong industrial base in Europe increases the potential number of suppliers and possibly the access to surplus stocks, too. Localisation of supply, on the other hand, concentrates risk domestically, reduces the diversity of potential suppliers and diminishes the pressure of competition and economies of scale. AESGP calls to strengthen mandate given to the Commission to explore diversification of supply chains of critical medicines through international partnerships and cooperations. Trade agreements or preferential treatment from supplying countries, ring fencing material goods for Europe, will go a long way in avoiding any future disruptions. Finally, we would like to express our concern about the potential negative impact of horizontal legislation on the security of supply of medicines. The Urban Wastewater Treatment Directive has substantial cost implications for the pharmaceutical industry and will affect both its supply capacity and the affordability of medicines. AESGP calls for re-evaluation of UWWTD considering its disproportionate burden on pharmaceutical industry and possible impact on availability of medicines. AESGP will collaborate with co-legislators throughout the legislative process and during its implementation once finalised.
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AESGP Urges Regulatory Reform to Boost EU Self-Care Competitiveness

17 Apr 2025
Topic — The EU strategy aims to restore global leadership in life sciences and innovation.
Message — AESGP wants longer data protection for medicines switched to non-prescription status. They request simplified regulatory procedures and a dedicated framework for live biotherapeutic products. The industry seeks a predictable and transparent regulatory environment for medical devices.123
Why — These changes would ensure rapid market access and lower costs for consumer healthcare.4
Impact — European healthcare systems lose billions if limited product access forces more doctor visits.5
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Meeting with Rainer Becker (Director Health and Food Safety)

25 Mar 2025 · Discussion on selected provisions of the pharma reform, Exchange of views on the Urban Wastewater Treatment Directive

Response to Implementing regulation for electronic instructions for use for medical devices

21 Mar 2025

The Association of the European Self-Care Industry (AESGP) representing manufacturers of self-care medical devices welcomes the European Commissions proposal for the update of the EU Regulation 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices. Going further, we believe additional digitalisation initiatives should be considered, such as the introduction of electronic instruction for use (eIFU) for medical devices available to lay users. Digitalisation is a key pillar that will foster increased Europes competitiveness, help streamline processes and reduce administrative burden of the Medical Devices Regulation (MDR). In addition, similarly to electronic Product Information that is currently discussed under Pharma Law Revision for medicinal products, eIFU will bring improved accessibility, searchability and ensure users have the most up to date version. We believe electronic instructions for use should be the primary format, but users should also have the possibility to get the instructions for use in paper format upon request. The addition of an item in the MDCG New Technologies action plan regarding the extension of the scope of eIFU to devices for lay users would be welcomed.
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Meeting with Sander Smit (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations

21 Mar 2025 · ENVI-general

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

The Association of the European Self-Care Industry (AESGP) representing manufacturers of self-care medical devices (i.e. devices that are generally available without medical prescription and are self-administered) welcomes the European Commissions targeted evaluation of the EU rules on medical devices and in vitro diagnostics. The MDR entered into force in May 2017 and is applicable since May 2021. The overarching objectives of the MDR are to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. After almost eight years of implementing the requirements and rules provided for in the MDR, it has become manifest that the objectives pursued by the MDR have not been attained. In fact, the regulatory framework as currently implemented under the MDR is marked by unpredictability, opacity, cumbersome and resource intensive processes as well as a high-cost environment affecting adversely business operators and, in particular, small-and medium sized enterprises. In other words, the current set-up of the regulatory framework undermines the innovative power and the competitiveness of the medical device industry and, notably, does not allow rapid and cost-efficient market access for medical devices, to the detriment of patients and healthcare professionals. In response to these challenges, AESGP developed a series of recommendations aimed at improving and optimizing the existing regulatory system, which can be found in AESGPs White Paper on lessons learnt with the MDR implementation (https://aesgp.eu/content/uploads/2024/04/AESGP_White-Paper_Future-Regulatory-Framework-MD_2024.pdf). These challenges are also a result of the shortcomings in the current multilayered governance system, which affect the efficiency of the CE marking process, leading to delays in device availability for patients and healthcare systems as well as challenges to the competitiveness of the medical technology sector in Europe. AESGP and the associations of MedTech Europe, COCIR, EEAR, EUROM as well as FIDE have developed joint discussion paper proposing to centralize key tasks and describing specific roles and responsibilities for a future centralised governance structure aimed at improving efficiency and effectiveness (see the attached file).
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Meeting with Ariane Vander Stappen (Head of Unit Health and Food Safety) and FoodDrinkEurope and

4 Mar 2025 · Discussion on the ongoing harmonisation of maximum permitted limits for vitamins and minerals in food

Self-care industry urges proportionate water strategy to protect medicine access

3 Mar 2025
Topic — This consultation concerns a multi-sectoral plan to achieve water resilience and security in Europe.
Message — AESGP calls for risk-based policies that avoid over-regulation and streamline existing processes. They advocate for a sector-neutral approach to waste treatment funding to ensure medicine affordability.12
Why — This would lower financial burdens on manufacturers and maintain the affordability of self-care products.3
Impact — Other polluting sectors may face higher costs if waste treatment funding becomes sector-neutral.4
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AESGP warns against mandatory onshoring of non-prescription medicines

27 Feb 2025
Topic — EU initiative to tackle medicine shortages and reduce pharmaceutical supply chain dependencies.
Message — The association requests that non-prescription drugs remain exempt from aggressive onshoring requirements due to their low shortage risk. They recommend prioritizing global supply chains and trade agreements over localizing production within Europe. They also call for mandatory impact assessments on any other laws affecting pharmaceutical production costs.123
Why — Avoiding mandatory onshoring prevents significant industrial expenses and maintains current medicine affordability.45
Impact — Patients may suffer from reduced access and higher prices if production shifts occur prematurely.6
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Meeting with Anne Simon (Head of Unit Health Emergency Preparedness and Response Authority)

24 Feb 2025 · Discuss how the AESGP can support and align with HERA mission Exchange of views on stockpiling, the catalogue, and program to follow regarding medical devices in terms of similar activities like Critical Medicines Alliance

Meeting with Vlad Vasile-Voiculescu (Member of the European Parliament)

29 Jan 2025 · Introductory Meeting

Response to Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)

15 Jan 2025

The Association of the European Self-Care Industry (AESGP) welcomes the opportunity to provide their comments on the proposed amendments to the Commission Implementing Regulation No (EU) 520/2012 on pharmacovigilance activities. Our comments concerns the proposed updates regarding the conduct of audits. Please find our comments attached.
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Meeting with Tomislav Sokol (Member of the European Parliament) and AstraZeneca PLC

14 Nov 2024 · Health policy

Meeting with Margarita De La Pisa Carrión (Member of the European Parliament)

23 Sept 2024 · Self-care products

Meeting with Tilly Metz (Member of the European Parliament)

18 Sept 2024 · pharmaceutical policy

Meeting with Lukas Sieper (Member of the European Parliament)

17 Jul 2024 · Introductory meeting at networking event

Response to Update of format of F-gas labels

4 Jun 2024

AESGP welcomes the opportunity to comment on the draft implementing regulation. AESGP supports comments of the International Pharmaceutical Aerosol Consortium (IPAC) which focus on labelling for metered dose inhalers (MDIs) for which extensive product labelling is required through medicinal product regulations. Their comments are reiterated below. MDIs present specific challenges and careful considerations with regard to adding F-gas labelling. The European Medicines Agency (EMA), respectively, the National Competent Authorities (NCA), who receive applications for the changes to MDI labelling will play an important role in reviewing and approving F-gas labelling before it can be added to MDIs for placing on the market. We welcome the legislative proposal and believe it takes a pragmatic approach that achieves the intent of the F-Gas Regulation whilst balancing implications for patients, and understanding unique challenges for labelling of MDIs. Managing the timeframe for implementing the labelling continues to be a critical issue to ensure uninterrupted supply of medicines for European patients. We therefore request an approach that allows necessary time for EMA and NCA guidance and requisite formal regulatory procedure to enable changes to MDI labelling in an efficient manner. We call for clarifying guidance reassuring that product supply and patient access to MDIs will not be negatively impacted due to the short time period that remains. Detailed Comments We welcome the clarification that labels on the outer packaging and package leaflet will assure compliance with Regulation (EU) 2024/573. It is, however, important to note that further detailed guidance is needed on the precise content and location of the F-gas labelling text to be added to package leaflet, to ensure consistency across MDIs and approvability with short timelines by EMA and Member States, respectively. Changes to labelling on outer packaging and leaflets require EMA approval in case of medicines that were centrally authorised by the EMA. Most MDIs currently marketed within the EU are not centrally authorised but are approved via national or decentralised procedures and the relevant changes in labels should be submitted nationally. AESGP notes the 2023 EMA guidance EMA/477469/2023 Section 3.6 which states that, for the introduction of new, low GWP propellants, Inclusion of statements such as HFC free on the label: As a general principle, the Summary of Product Characteristics (SmPC) is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. There is no ground or need to include additional information on elements which are not included in a medicinal product (i.e., absence of a component in the product or in a container), as the information may become extensive and confusing. Therefore, such promotional statement is not allowed Article 1 (10) proposal for adding a digitally readable link does not appear to be an option for MDIs which are medicinal products for which there are specific rules and restrictions for how digital links can be approved on labelling. Article 1 (11) states that the indication Contains fluorinated greenhouse gases should be included in the labelling. However, we suggest that this be changed to Contains a fluorinated greenhouse gas as MDIs do not contain multiple fluorinated gases. We consider the Act is missing a clarification specific for MDIs in relation to the requirements of Article 12 (16) of the Regulation 2024/573 and F- gas. Adding F-gas labelling to advertising of MDIs that is not directly related to the medicines properties may not be aligned with the Medicinal Product Directive (2001/83/EC) and its restrictions for advertising content of medicinal products. A clarification is therefore considered necessary.
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Response to Evaluation of the European Food Safety Authority (EFSA) 2017-2024

8 Apr 2024

AESGP, the Association of the European Self-Care Industry, welcomes the opportunity to provide feedback on the performance of the European Food Safety Authority (EFSA) as part of its evaluation for the period 2017-2024. You will find our feedback attached. We thank you in advance for your consideration.
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AESGP urges impact assessment for EU chemical streamlining package

3 Apr 2024
Topic — A proposal to streamline chemical safety assessments across EU legislation and agencies.
Message — AESGP requests a full impact assessment and asks that pharmaceutical regulations take precedence. They also seek a mechanism to comment on studies commissioned by the chemicals agency.12
Why — This would protect commercial data and prevent competitors from reusing expensive research results.3
Impact — Agencies monitoring emerging risks lose efficiency due to proposed delays in identification timelines.4
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Self-care industry urges pharma priority in EU chemical rules

3 Apr 2024
Topic — The consultation focuses on streamlining chemical safety assessments through improved EU agency cooperation.
Message — AESGP insists that the European Medicines Agency must lead health product evaluations and that comprehensive impact assessments are performed. They further demand strict confidentiality protections for business data within the proposed common platform.12
Why — Maintaining EMA leadership ensures that specialized medical expertise continues to govern product approvals.3
Impact — European citizens risk medicine shortages if new regulations hinder the continuous global supply.4
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Self-care industry urges confidentiality protections in chemical data sharing

3 Apr 2024
Topic — The European Commission is consulting on streamlining chemical safety assessments through a centralized platform.
Message — The organization demands a full impact assessment and stronger confidentiality safeguards for sensitive data. They insist the European Medicines Agency must retain primary authority over health product evaluations.12
Why — These measures would protect proprietary manufacturing secrets and prevent non-specialist agencies from restricting medicines.3
Impact — Environmental monitoring groups and the public would face delays in identifying emerging chemical risks.4
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AESGP urges extended transition for BPA phase-out in packaging

8 Mar 2024
Topic — EU consultation on restricting bisphenol A and other bisphenols in food contact materials.
Message — The association requests 36 to 60 months to transition away from BPA-containing packaging. They need time for complex stability testing and identifying safe alternatives for medicines.1
Why — This extension would allow companies to maintain regulatory compliance while avoiding significant waste and costs.2
Impact — Consumers lose access to essential self-care products if short timelines cause market supply gaps.3
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Response to Revision of the variation framework for medicines

29 Feb 2024

AESGP, the Association of the European Self-Care Industry, represents manufacturers of non-prescription medicines (NPM). We appreciate the opportunity to be consulted on the draft Delegated Regulation on Variation. We appreciate that some of the proposals seem to address some of the issues we have been facing in terms of non-harmonized classification of variations within EU. We also see very positively new initiatives focusing on decreasing the administrative work and complexity, like the creation of the Super-grouping of variations IA in which medicinal products approved via the national, mutual recognition or decentralised procedures can now be included. We would like to extend this pragmatism to the following matters: - Introduction of a principle of downgrading for variations that have no impact on quality, safety, and efficacy if justified by the MAH on a risk-based approach or where a particular condition (introduced in the variation classification guideline) is met. This principle would enable competent authorities to focus on substantial issues, reduce the administrative burden for authorities and industry, add to the flexibility of the system, and strengthen a proportionate way of assessment based on a risk-based approach. - The principle of automation and leveraging the OMS/PMS database should be enshrined in the variation framework as it would allow a huge gain of resources. The successful precedence created by article 57 database for PSMF location and QPPV contact details change in the current system should be extended to other pure administrative changes having no impact on quality, efficacy and safety. The variation guideline should provide the option to use the SPOR database, and this should be reflected with an asterix and the Footnote: This variation covers []. Once the PMS database is functional, changes to [] may be updated through the PMS database only (without the need for a variation). - Reducing the complexity and the timelines for unforeseen variations (Article 5) - Type IA annual notification/reporting should remain a choice of the applicant; the same should apply to worksharing. This allows maximum flexibility to ensure a secure supply chain. - We note that removal of Type II classification for manufacturing changes is implemented for biologicals. The same principles apply to herbal medicines. As for biologicals, experience and trust have been gained in course of the past decade with use of the variation guideline and a level playing field should apply.
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Meeting with Stelios Kympouropoulos (Member of the European Parliament)

15 Feb 2024 · discussion on the revision of Pharmaceutical Legislation

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

26 Jan 2024 · Pharmaceutical legislation

Response to Revision of the definition of engineered nanomaterial in food

12 Jan 2024

AESGP, the Association of the European Self-Care Industry and representing manufacturers of food supplements welcomes the opportunity to provide feedback on the Commission Proposal for a Delegated Regulation amending Regulation (EU) 2015/2283 on novel foods as regards the definition of engineered nanomaterials. The feedback is provided in the document attached.
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Self-care industry urges automated updates for medicine variations

26 Sept 2023
Topic — The EU is updating rules for post-authorisation changes to medicine marketing authorisations.
Message — AESGP requests automatic processing for administrative updates and simpler rules for lower-risk changes. They seek equal treatment for herbal and chemical ingredients.12
Why — Faster updates and lower compliance costs would improve their market responsiveness.3
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EU self-care industry urges realistic timelines for green claims

20 Jul 2023
Topic — New EU rules for substantiating and communicating explicit environmental product claims.
Message — We recommend extending the timelines for application to thirty-six months. Digital means like QR codes should be allowed for providing required evidence. Self-certification would be a more proportionate approach for certain clear claims.123
Why — This would reduce the financial burden and prevent increasing packaging sizes.4
Impact — Strict rules for new private labeling schemes create barriers for market entry.5
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Response to Evaluation and revision of the general pharmaceutical legislation

19 Jul 2023

AESGP expresses support for the Commission Proposal to revise the EU general pharmaceutical legislation. We believe this long-awaited revision will consolidate and streamline legislation which underwent multiple updates over the past 20 years. While AESGP members acknowledge the legislation's goals, we raise concerns on unintended consequences for non-prescription medicines (NPMs). AESGP argues that certain proposed changes may negatively impact medicine availability, patient access, and the sustainability of healthcare systems. Regarding prescription status, we are concerned that the broad definition of antimicrobials in the proposal encompasses antivirals and antifungals, available as topical-use NPMs. We consider that restricting the use of these products without scientific reason could lead to delayed treatment, increased dosages, and longer-term usage, adversely affecting public health and burdening healthcare systems. The prescription status criteria applied for environmental reasons is also inadequate to reduce environmental exposure. We suggest prescription criteria to be limited to antibiotics with confirmed AMR risks and to be removed for environmental concerns. AESGP is aware of environmental risks associated with pharmaceuticals. While we recognize the importance of environmental risk assessments (ERAs) for human medicines, we found some shortcomings in the proposal. We underline issues like repetitive studies, inconsistent conclusions, or inequitable testing burdens. So, we recommend an extended ERA (eERA) as the primary regulatory tool for environmental assessment and stress the need for high-quality scientific data and alignment across agencies and legislative dossiers. On medicine shortages, we emphasize the commitment of the pharmaceutical industry, including NPMs, to avoid shortages and mitigate their effects. We suggest that requirements for shortages prevention plans and notifications should be limited to critical NPMs, with notifications made 2 months prior to the occurrence. We would oppose granting specific powers to MSSG to mandate inventory management and supplier diversification, arguing that companies should be flexible to adopt the most appropriate shortages management strategies. As AESGP, we criticize the lack of adequate measures to incentivize innovation and investment within the EU for the change of legal status from prescription to non-prescription. We highlight the need to weigh various types of evidence, like behavioural studies and RWE, when assessing the safety, effectiveness, and healthcare contribution of a switch. We also reason that current 1-year data protection is insufficient, as the EU lags behind other markets (US and Japan grant 3-year data protection). Regarding product information, we call for a smooth transition to digital product information due to its benefits. We recommend a stepwise approach, starting with simplification of paper patient information leaflets and introduction of detailed digital leaflets as a complement. On regulatory agility, we appreciate that marketing authorization procedures remain unchanged and procedure timings are shortened. However, we suggest removing requirements related to member state notifications and opt-in provisions, as other mechanisms can improve access and availability. As AESGP, we propose maintaining the well-established use application route to foster innovation in the self-care sector and avoid unnecessary clinical trials. We recognize the potential of RWD/RWE to inform authorities' decisions on medicines, particularly on legal status, safety, and effectiveness. So, we call for broad definitions of RWD/RWE fit for NPMs. As for pharmacovigilance, we suggest extending the generics exemption on submitting risk management plans (RMP) to medicines of well-established use without significant safety concerns. For other product categories, we support a risk-based approach to RMP, based on existing safety information and indications.
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

13 Jul 2023 · Directive on Medicinal products for human use

AESGP urges healthcare-specific flexibility in EU packaging rules

24 Apr 2023
Topic — The Commission is reviewing packaging requirements to promote recycling and waste prevention.
Message — AESGP demands packaging rules remain coherent with existing healthcare safety legislation. They seek exemptions for all medical device materials and request digital labeling. The industry also wants longer transitional periods to ensure legal certainty.123
Why — This approach protects their market access while lowering administrative costs for proving packaging minimization.45
Impact — Environmental goals could be undermined if industry-led exemptions delay the reduction of non-recyclable materials.6
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Self-care industry calls for consistent chemical classification rules

30 Mar 2023
Topic — This consultation covers revisions to EU rules on classifying and labeling chemical substances.
Message — AESGP advocates for a consistent Weight of Evidence approach for chemical classification. They request the removal of burdensome notification requirements that offer no practical benefit. Finally, they demand alignment between chemical regulations to prevent unnecessary confusion.123
Why — Streamlined regulations would reduce compliance costs and avoid regulatory uncertainty for manufacturers.45
Impact — EU regulators would lose access to specific justifications for deviations in chemical hazard labels.6
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Meeting with Deirdre Clune (Member of the European Parliament, Shadow rapporteur) and European Environmental Bureau and

29 Mar 2023 · Stakeholder Consultation on Urban Waste Water Treatment Directive

Response to Revision of the Urban Wastewater Treatment Directive

14 Mar 2023

AESGP welcomes the opportunity to submit feedback to the UWWTD proposal, due to direct impact on pharmaceutical industry, by including an Extended Producer Responsibility (EPR) scheme to finance the establishment of quaternary treatment in UWWTPs to deal with contaminants of emergent concern (CEC). Pharmaceutical industry is aware that substances contained in medicinal products are detected in trace amounts in European surface waters. We are supportive of the UWWTD proposals objective (to protect environment and human health from urban wastewater discharges adverse effects) and committed to play our part and work with all stakeholders in achieving this objective in a fair and equitable way. Due to the mechanism of action of active substances in medicines (API), which are designed to interact with biological systems, some have been identified as having potential environmental concern. Human medicines enter the environment predominantly through individual patient use, while smaller proportions are due to improper disposal associated with expired or unused product, and even less through manufacturing. We have serious concerns that the EPR scheme proposed is neither fair, nor proportionate, nor based on sound scientific evidence. Critically, it neglects to adequately apply the polluter-pays principle by failing to consider all stakeholders contributing to micropollutants in UWW. Focus of the EPR provisions should be substance-specific and not sector-specific. All stakeholders responsible for micro-pollution should, therefore, be part of the solution to ensure higher water quality and address the overall micropollutant footprint. The definition and identification of micropollutants should be built on risk-based principles, amended by certain hazard properties, as established under several other EU regulations. The EPR scheme should ensure that substances with reduced or no impact are delisted from the EPR scheme. The Feasibility Study / Impact Assessment of this revision fails to: - Engage with the targeted sectors in consultations at the working level; - Transparently assess EU representative data on micropollutants; - Acknowledge other toxic, persistent or hazardous substances coming from other manufacturers that will benefit from UWWTP infrastructure and technology upgrade; - Provide solid evidence that pharmaceuticals are among lead contributors of micropollutants. It significantly overestimates the amounts of pharmaceuticals reaching the environment by not considering drug metabolism, biodegradation data, or removal of substances by absorption to sewage sludge; - Recognise evidence-based studies led by independent organisations, academia, regulators, and industry; - Make fair cost-estimations for build-up and maintenance of quaternary treatment; - Evaluate impacts on product costs and profit margins (very underestimated); - Benchmark Swiss model of UWWT to understand costs and implementation timelines, to propose a proportionate and realistic system; - Provide justification for an exoneration below 2 tonnes of finished product (under REACH it is considered for substance and API is a very small fraction of the weight of a product). The proposed stakeholder-based model governance for Producer Responsibility Organisations, if acting as fee-collectors alone, will create high administrative costs associated with establishing, managing, and supervising such organisations. To a large extent, most pharmaceuticals are already efficiently managed by UWWTP. Pharmaceutical residues are only a fraction of micropollutants that an improved WWT would control. EPR, if applied only to a tiny subset of industry, as currently proposed, would be inadequate and disproportionate. Moreover, this proposal could be inconsistent with the Pharmaceuticals Strategy by hindering continued patient access to efficacious medicines and increasing healthcare costs. Please read attachment for detailed feedback and data from the Pharmaceutical Industry.
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Self-care industry demands scientific rigor in EU water rules

14 Mar 2023
Topic — EU initiative to update lists of priority substances and groundwater pollutants.
Message — The industry opposes the shift to delegated acts to preserve transparency. They request removing the aggregate limit for pharmaceuticals in groundwater. They demand that pollutant lists be based on high-quality scientific data.12
Why — This would protect existing manufacturing sites from potentially prohibitive new emission permits.3
Impact — The European Parliament and Council lose their direct influence over pollutant revisions.4
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Response to Revision of EMA fees

7 Feb 2023

Please see below the AESGP comments on the European Commission proposal on updating the rules on fees payable to the European Medicines Agency. The detailed comments are provided in the attached document. The EMA is currently funded at 86% by fees, 13% by EU contribution and 1% by other sources. It is crucial to have financing system for the European Agency that is sustainable, balanced and ensure the Agency can adequately perform its current tasks but also quickly adapt to the fast evolution of science and medical needs. It is to be noted that the EMA has a public health role which has increased with the pandemic and shortages issues and has taken a toll on its other activities; this important public health role should be adequately financed through EU financing. It is also key that appropriate funding is given to digitalise the Agency. In turn, EMA should be made accountable to the proper use of funding for upgrade of its digital services in a timely manner. Moving forward and taking into account the developments at EU level, it is quite clear that the EMA will need to be more equipped with experts to be able to generate more core science rapidly in coordination with the agencies network. The One substance one assessment for example will make important that the EMA can generate data adapting the hazard assessment to a risk assessment in the context of medicinal products. Other fast evolving scientific areas makes it critical that the EMA can promptly generate data in coordination and supported by the committees members and experts. We observe a general increase of all fees and a split with rapporteur and co-rapporteur which is generally increasing from 50% ensuring that national assessors get a bigger share. We will not comment on the dividing of amount between EMA and NCAs however it is critical that the amount going to the rapporteur, co-rapporteur and their respective teams appropriately and adequately retributes the services and performances given to the assessment. We also positively note the simplification and streamlining in the number of existing fees. One of the areas where the fee has drastically decreased is in scientific advice and we believe this is a positive step toward encouraging innovation and attracting more scientific advice to the EMA independently of the route then chosen by the applicant. This being said it is key that the services provided are adequately financed and that this does not give a wrong signal that SA are of lesser focus of the Agency. At the opposite, the fee for MAA review has almost doubled and we fear that this may act as a disincentive to put innovative products on the market. We echo the feedback of the impact assessment board that the impact on stakeholders, notably on industry is unclear and moving forward we make the plea that stakeholders, notably industry, are proactively engaged in any future revision or key update.
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Response to Fitness check of how the Polluter Pays Principle is applied to the environment

9 Dec 2022

Polluter-Pays Principle (PPP) is a key element in European environmental policy where the waste producer bears the costs of waste management to guarantee a high level of environmental and human health protection. PPP and Extended Producer Responsibility (EPR) are often used interchangeably although, technically, EPR is a specific application of PPP. On another hand, the User-Pays Principle (UPP) is a variation of the PPP that calls upon the user of a natural resource to bear the cost of its waste management. Governments worldwide adopt UPP in relation to public services including waste. The user-pays principle promotes more responsibility and accountability in relation to the environment and the consumption of increasingly scarce resources. EPR has been applied in the case of human medicines, as several take-back schemes have been put in place in EU Member States to avoid disposal of unused or expired medicines through solid waste or water effluents. Some of these collection systems were established and financed by the different stakeholders of the medicines value chain through Producer Responsibility Organizations (PROs), which have been tasked to gather fees to finance the collection and treatment of the waste stream, and to plan and operate the functioning of the system. While EU legislation often sets the framework for EPR in different areas, Member States have different understandings on how it is applied and who is defined as the polluter. For example, there are many factors to take into consideration between the need for and the use of a medicine. So, responsibility for pharmaceutical substances can be attributed to many stakeholders even beyond the lifecycle of a product. Medicines active pharmaceutical ingredients (APIs) are a particular case of contaminants of emerging concern (CEC), since they are used to prevent, treat and cure diseases, with significant impact on improving public health and economy. Therefore, any environmental measures to be applied, need to consider and differentiate human medicines as essential public goods, access to which must be ensured. The intent of applying EPR, however, with a purpose to incentivize greener products, is not a realistic or feasible option for human medicines. APIs, which originate mostly of human excretion, are increasingly detected in the environment due to improved analytical technology, greater demographic concentration in urban areas, and people living longer, healthier, more productive lives. The centralisation of urban wastewater infrastructure and operations can result in hotspots of CECs in surface water downstream of wastewater treatment plants. But a WWTP operator that fails to take steps to improve the removal of CECs from wastewater may qualify as polluter by omission, and thus, under PPP, be required to take such responsibility. Other product manufacturers can sometimes benefit from the implementation of waste removal technologies (free-riders). There is great difficulty in pinpointing responsible parties for some of the CECs these include natural or synthetic chemical substances that have the potential to cause adverse ecological or human health effects (e.g. natural hormones, lifestyle substances and drugs of abuse). PPP needs to balance other options and environment protection tools. Such is the case for medicines where there is an Environmental Risk Assessment before entry to market to evaluate potential consequences to wildlife and biodiversity, and the application of environmental risk mitigation measures if needed. AESGP represents manufacturers of non-prescription medicines, food supplements, and self-care medical devices in Europe, also known as self-care or consumer healthcare products. AESGP members are committed to help finding solutions that will efficiently solve environmental risk of the use of their products, while protecting EU citizens right to healthcare. See attached White Paper for further explanation and evidence sources.
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AESGP demands ECHA reform respect health and food agency competencies

10 Oct 2022
Topic — This consultation aims to modernize the governance and financing of the European Chemicals Agency.
Message — AESGP insists that ECHA's new responsibilities must not undermine the powers of agencies like EMA and EFSA. They also request a formal impact assessment to address potential effects on self-care products.12
Why — This prevents new financial burdens and maintains regulatory stability for manufacturers.34
Impact — Scientific committees risk losing their established expertise through work transfers to ECHA.5
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Self-care industry urges transparency for new chemical data rules

16 Aug 2022
Topic — Initiative to improve chemical data sharing and streamline safety assessments across EU regulations.
Message — AESGP requests a formal impact assessment and clear written guidelines for this initiative. They advocate for a reporting mechanism to ensure the rules simplify existing processes. They also seek to review cost-benefit analyses before policies are finalized.123
Why — This would prevent unexpected compliance costs and ensure new rules actually simplify reporting.4
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Self-care industry calls for digital literacy in health data space

28 Jul 2022
Topic — The consultation addresses a regulation creating a shared European health data space.
Message — The association asks for digital literacy programs to help people understand their data. They also recommend including information on non-prescription medicines and wellness apps in health records. Finally, they advocate for using real-world data to improve healthcare delivery.12
Why — This would streamline the development and marketing of non-prescription medicines and supplements.3
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Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

24 May 2022 · Exchange of views on the upcoming reform of the pharmaceutical legislation

Response to Streamlining EU scientific and technical work on chemicals through the EU agencies

12 Apr 2022

AESGP welcomes the consultation initiative and the stakeholder engagement on the principle of ‘One Substance – One Assessment’ as part of the commitment in the ‘European Green Deal’. It is essential for AESGP that the implementation of the ‘One Substance - One Assessment’ (OSOA) concept which aims to reduce the administrative burden, duplication of efforts and to optimize resources does not have a negative impact on ensuring the access to safe self-care products to citizens in Europe. It is worth highlighting that the ‘fitness check of all chemical legislation’ mentioned in the Call for Evidence also excluded the pharmaceutical legislation from its scope and has no focus points on Food Supplements. For this reason, the envisioned OSOA concept has unknown application at the moment on OTC Medicines or Food Supplements. AESGP supports an approach where substances undergo a ‘One substance - One Assessment’, consisting of a first step ‘One Substance - One Hazard Assessment’ in which the hazard is defined by the intrinsic properties of the substance. This should be followed by a second step specific to each sectorial legislation covering the ‘specific risk assessment and management’, in which the risk resulting from each specific product application is assessed. We believe that each Agency is best positioned to lead and provide such specific assessment due to their extensive experience in product specific related matters, e.g., EFSA for food use, EMA for medicines use, as this would account for sector specific knowledge important for consideration during risk assessment. Additionally, it is not clear how adequate funding of all involved agencies would be secured. The hazard-risk ratio must also be viewed critically. For the same hazard, the risk for an application (e.g., medicinal product) can be significantly different compared to the substance being used as an industrial chemical in closed systems. Here, a higher risk must not lead to an overestimation of the consequences under completely different exposure scenarios. Furthermore, the safety/environmental risk of a substance should be carefully weighed against its benefits depending on its use. Similarly, depending on the risk assessment, a proportionate and nuanced risk mitigation plan would be needed according to the use of the ingredient in different types of products. We acknowledge the importance of providing greater transparency when prioritizing action to deal with chemicals’, in order to improve trust in both decision-making and risk assessment process itself. Taking into account the learnings from the implementation of the Food Transparency Regulation (EU) 2019/1381 which is applicable since 27 March 2021. It is most important that the efficiency of the European agencies is not negatively impacted by the reallocation of tasks and/or any changes introduced in the way the technical and scientific work is currently handled. AESGP supports the principle of harmonizing the format in which data is reported to enable data to be shared between agencies. A harmonized data format will in our opinion lead to efficiencies and greater transparency. To us a harmonized data format does not equal harmonized data requirements between agencies since adequate data required for a risk assessment depends on the sector considered. It would be important to have a systematic mechanism supported by the authorities to organize the request of data to the manufactures to avoid duplication of efforts/resources and to guarantee a good agreement among the interested parties. The format of all data collected should be developed in close collaboration with the industry to ensure it is fit for purpose. Considering the expected impact on our sector, AESGP would like to express interest to be part of the upcoming targeted consultation with relevant stakeholders on this process.
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Response to Solutions to ensure continuity of supply of human medicines to Northern Ireland, Ireland, Cyprus and Malta

18 Mar 2022

AESGP, the Association of the European Self-Care Industry, representing the manufacturers of non-prescription medicines, appreciates the opportunity to provide feedback on the proposal for a Directive amending Directives 2001/20/EC and 2001/83. AESGP welcomes the Commission Proposal and legislative changes, which we consider have addressed the key concerns to ensure the uninterrupted supply of medicines to Northern Ireland as well as small markets historically reliant on the supply from the United Kingdom, notably Cyprus, Ireland and Malta. The proposal and the legislative detail provide the clarity industry was seeking to ensure that the proposed solutions would prevent barriers to supply. AESGP appreciates that the proposed legislative changes have addressed the three main concerns that, from a non-prescription medicines’ perspective, needed to be addressed and clarified, notably: - Marketing authorisation and licences, in particular the ability to locate key regulatory compliance functions in Great Britain (England, Wales and Scotland) - Regulatory importation requirements from GB to NI as well as Cyprus, Ireland and Malta. - Ability to effectively supply and distribute the same product throughout the UK Following a review of the legislative proposal, there are a few further clarifications that we would appreciate being addressed. It is however noted that some of these clarifications may more appropriately be addressed in the accompanying guidance. AESGP hopes that the legislative process will be concluded in a timely manner to ensure legal certainty for the industry as well as uninterrupted supply of medicines to patients in Northern Ireland, Cyprus, Malta, and Ireland.
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Meeting with Sandra Gallina (Director-General Health and Food Safety)

9 Sept 2021 · Presentation of the work of AESGP and perspectives from the self care industry on the pharmaceutical strategy.

Response to Requirements for Artificial Intelligence

6 Aug 2021

AESGP welcomes the European Commission’s effort to develop a European approach for artificial intelligence (AI) that promotes Europe’s innovation capacity while ensuring the creation of an ethical and trustworthy AI. If properly addressed, AI could bring tremendous benefits to the healthcare sector as a whole and some of its potential applications are already described in numerous publications. Particularly in the self-care sector, AESGP believes that AI can help fostering a personalised self-care approach and empowering people to better manage their health and well-being, especially regarding the prevention, early detection and treatment of potential health concerns. AI, by analysing data shared by consenting individuals, could support them in practicing correct self-diagnosis and responsible self-care. AESGP welcomes the risk-based approach but calls for internationally aligned criteria Supervision of AI should be indeed proportionate to the intended use and led by defined risk categories with clear internationally defined criteria. Data governance is a cornerstone for AI policy development Discretionary application of GDPR and market fragmentation are major issues that need to be properly addressed in the coming years, concomitantly to AI policy development. Clearly defined accountabilities and liabilities that allow progress and utility of AI The development and use of AI-powered tools is subject to different contributors. As the development of the various applications of AI is progressing, it is becoming absolutely necessary that accountabilities and liabilities are clearly defined, in respect of user safety, developers’ guidance and business certainty. A regulatory framework with flexible mechanisms for quick adaptation to technology evolution As recognised in the regulation proposal, the current fast-paced development of new technologies requires a change in the way these new services/products are regulated. Fair and horizontal regulation In the healthcare sector, the pharmaceutical industry is used to working in a highly regulated environment. The various types of products must follow a strict procedure of safety testing and extensive evaluations of their benefits before any marketing authorisation is issued by the authorities. Industry actors such as digital developers may be new to this highly regulated environment of traditional healthcare. Without overly limiting access to innovative technologies, regulators must ensure a fair level playing field for all actors by drafting and enforcing horizontal regulations across sectors while taking into account the particularities of the healthcare sector, respecting the benefit/risk profiles of the products and the data privacy of the patients. Empower people’s health and digital literacies for better understanding and use of AI If general population is more informed on the added value of healthcare data for individuals and society, it could be more prone to register and use data while, consequently, increasing data quantity and quality. Information on rights, duties and possibilities granted by the use of healthcare data will create more competent and confident citizens in dealing with digitalization. The prerequisites must, therefore, be met for individuals to be the responsible owners of their data and to enact this sovereignty. Having everyone digitally and data literate will not only ensure responsible and adequate use of the digital tools, but will build trust and confidence in the system as well. Europe must ensure a fit for purpose regulatory framework so that people can safely enjoy the benefits brought by digital transformation and new technologies. AESGP believes that industry, regulators, legislators and society at large have to work together to accelerate the effort, if Europe is to become a leader in the digital health space.
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Response to Food safety – restrictions on the use of monacolins from red yeast rice in foods

17 Jun 2021

The Association of the European Self-Care Industry (AESGP) would like to use the opportunity provided by the Commission to comment on the draft Commission Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice. AESGP would like to share the following comments on the draft Commission Regulation for consideration by the Commission and the national competent authorities and ask for a revision of the draft to address these: - The label warning “Seek advice from a doctor on consumption of this product if you experience any health problems” should read instead “Seek advice from a healthcare professional” on consumption of this product if you experience any health problems” The additional requirements section under Part B includes the warning statement “Seek advice from a doctor on consumption of this product if you experience any health problems”. Considering the nature and availability of food supplements, we would like to note that consumer must be able to consult the pharmacist for advice and we therefore request to replace “doctor” with “healthcare professional”. Restricting advice to only doctors could be confusing to consumer and would not encourage them to be sufficiently informed. - A proportionate transition time should be provided AESGP acknowledges the purpose of Article 8 procedure and considers the safety of consumers of utmost importance, however we are of view that a direct prohibition without an appropriate transition period would create confusion among consumers and would not be proportionate. In view of the time already elapsed since the adoption of the EFSA scientific opinion on the evaluation of the safety of monacolins from red yeast rice in June 2018, we understand that there are no grounds of urgency. We would therefore propose that the Regulation includes a transition period for the substance referred to in the Article 1 and placed in Part B of the Annex III to Regulation (EC) No 1925/2006. Such a transition period would allow business operators to properly assess their product, reformulate them and adjust the labelling of the products.
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Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

7 Jun 2021 · VTC meeting - Access to Medicines

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

A FIT PHARMACEUTICAL LEGISLATION TO BENEFIT E.U. CITIZENS AND HEALTH SYSTEMS AESGP supports a pragmatic and risk-based regulatory framework that fosters a stronger role for self-care and prevention. The current structure is overall fit for purpose although some issues may arise from divergent interpretation, disharmonised application and addition of gold plating or administrative elements. These can be tackled through non-legislative initiatives. AESGP fully supports the ‘targeted approach’ pursued by the Commission for this exercise based on the recognition of the well-established dual marketing authorisation system in the EU. For the sake of legal certainty and regulatory efficiency, keeping the existing legal instruments fits best the objective of this targeted approach. Updates to existing policy and guidance documents must be considered as valid instruments to deliver on the objectives. We believe that a solid analysis of the existing regulatory framework and impacts of the proposed measures under each considered policy option is critical to achieving a proportional legal proposal. AESGP is committed to engaging in an open dialogue with all stakeholder groups to achieve common objectives for this initiative. In carrying out this analysis, the interconnection of the pharmaceutical legislation with the ongoing proposals for the reinforced role of EMA, the creation of HERA, the ongoing implementation of the Medical Devices Regulation must be taken into account so as to avoid unnecessary duplication of initiatives. AESGP would also like to highlight the following important considerations for developing the policy options: 1. FACILITATE AND ENCOURAGE THE CHANGE OF LEGAL STATUS OF MEDICINES, to ensure greater access and availability of non-prescription pharmaceuticals, to ensure routes to market function well, continue to be the choice of applicants and that timelines are respected. Easing regulatory procedures for trusted molecules, which have been commercialised for many years and have a well-established safety profile, would help non-prescription medicines’ availability for the benefit of the European citizens. 2. MODERNISE THE CURRENT VARIATIONS SYSTEM to reflect evolution in technology and regulatory needs. Possibility of a leaner quality documentation and reliance on telematics for variations not necessitating a review, would be desired. The same classification should apply to all medicines irrespective of their chemical or herbal nature. 3. ENHANCE REGULATORY FLEXIBILITY, proven useful during the COVID19 crisis, in a post-pandemic scenario to foster a smart regulation approach: specific measures which have been introduced could be considered for permanent establishment. 4. DEVELOP THE ELECTRONIC PATIENT INFORMATION for human medicines, as a helpful addition to the paper leaflet, to increase patient safety and foster availability of medicines. Improve the content of the leaflet reflecting patients’ needs and adherence improvement. 5. UNLOCK THE HIGH POTENTIAL FOR RWD/RWE by ensuring its acceptance for non-prescription medicines, throughout their life cycle, and would appreciate that the reference would not be limited to supporting the development of medicinal products for unmet medical needs. 6. ENSURE A PROPORTIONATE AND REALISTIC APPROACH TOWARDS TELEMATICS projects and deliverables (taking into account regulators’ resources). 7. SUPPORT ENVIRONMENTAL RISK ASSESSMENTS to cover product lifecycle and address sustainability via initiatives like #MedsDisposal and non-legislative initiatives encouraging prudent use of pharmaceuticals. 8. ENSURE PROPORTIONALITY of any measures aiming to prevent shortages to the level of risk of the product to be in short supply and not having therapeutic alternatives. Smart regulation can be a way forward to increase accessibility and availability of pharmaceuticals to patients. AESGP is looking forward to the dialogue with the European institutions on the proposed actions.
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Meeting with Margaritis Schinas (Vice-President) and

8 Apr 2021 · Health Union

Response to European Health Emergency Response Authority

24 Feb 2021

EUROPEAN HEALTH RESPONSE: GETTING TOGETHER TO BETTER PREPARE AESGP supports the proposed Better Regulation approach which integrates an impact assessment to accompany the legislative proposal for the establishment of a European Health Emergency Preparedness and Response Authority (HERA). AESGP would like to share some views regarding the objectives and policy scenarios described in the Inception Impact Assessment. // PEOPLE-CENTRIC APPROACH ALLOWS TO WEIGH THE POSSIBLE IMPACTS OF A CRISIS AESGP believes that impacts should be evaluated from both a health system and a people-centric approach, factoring in other options such as availability of other disease prevention and therapeutic solutions aiming at the same healthcare outcomes. There needs to be a strict dialogue with supply chain stakeholders, responsible for different stages of manufacturing and distribution, taking into consideration benefits of affordability drawn from a competitive global market of pharmaceuticals and medical devices. // GOOD STRUCTURE AND COMMUNICATION AVOID DUPLICATING REGULATORY AND EXECUTIVE EFFORTS Equipping the Union with HERA needs to take into account the EU institutional setting, namely already existing structures such as RescEU, EMA and ECDC (with reinforced mandates), and provide for a coordinated approach to health preparedness encompassing Member States competences in this area. Leveraging the network of Human Medicine’s Authorities could also expedite mutual recognition procedures, which AESGP deems of critical importance in emergency situations. // EVIDENCE-BASED POLICIES AND DECISIONS HELP GETTING IT RIGHT FIRST TIME Any of the policy options to be followed should be proportional to the aims of “equitable access, availability and distribution”. AESGP highlights the counter-productiveness of increasing manufacturing capacity or stockpiling finished product in a Member-state to the detriment of API availability to other Member-states. AESGP would further welcome the prior collection of evidence to support that “pooling resources into a centralised focal point to be the most effective way to ensure the scale necessary for speedy and successful outcome”, especially given the unpredictable nature of the health crises – and the necessary products thereof. // FOSTER SEVERAL SHORT-, MID- AND LONG-TERM SOLUTIONS TO A MULTIFACTORIAL PROBLEM AESGP understands the long-term reach for a “European strategic autonomy and production capacities”, but also believes that reinforcing diplomacy channels is paramount to secure transit of not only APIs, but other raw materials as well, which would be indispensable for the manufacturing of the to-be-determined essential products for each crisis. // PRODUCTION CAPACITY AND ADAPTABILITY NEEDS TO BE PAIRED WITH REGULATORY FLEXIBILITY So far, pharmaceutical industry has been able to work with stockpiles at API production level, which have helped to adapt manufacturing according to the crisis-led needed characteristics (such as dose or pharmaceutical form) and to market particularities (such as packaging/labelling). AESGP believes that sourcing from the European single market in times of necessity needs to come with regulatory flexibility for timely approvals and registrations. Healthcare product manufacturers are private sector enterprises with strict legal obligations in respect to contracts and agreements. The extent of powers of HERA would need to recognise this nature and to be able to, in times of crises, work out solutions with these stakeholders. // HEALTH LITERACY MAKES FOR MORE RESPONSIBLE CITIZENS AND AVOIDS MARKET DISTORTIONS Finally, AESGP would like to draw attention to the importance of creating conditions to avoid unnecessary surge demand and panic provisioning by European citizens, which distort market supply, by leveraging trustworthy information sources and reinforcing health literacy to deal with each crisis. :: An extended version of the reply is provided in attachment ::
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Response to A European Health Data Space

3 Feb 2021

LET THE KNOWLEDGE CONTAINED IN DATA OPEN DOORS TO THE FUTURE OF HEALTHCARE AESGP welcomes the European Commission’s Combined Evaluation Roadmap and Inception Impact Assessment on A European Health Data Space and its ambition to introduce innovation, to take advantage of digital technology developments and to deliver concrete results to improve healthcare in Europe. A Health Data Space should aim to be more person-centric, in the sense that it needs to take into consideration the patients’ needs and their personal contributions, and not circumscribe the assessment to professional, governmental or administrative views of healthcare. Only with patient generated data will the EHDS achieve an added value that proves successful. There is a pool of valuable data with impact on healthcare that is not currently structured which could, under voluntary data submission, prove useful for personal care. There is data which already fails to be routinely captured in electronic health records, like non-prescription medicines’ and food supplements’ intake. In order to encourage and enable Real World Data research, these should be recorded in order to enable a more holistic view of individuals. AESGP would like to highlight that, due to new technologies (wearables and other bio-sensors), the number of potential sources of data has increased. AESGP welcomes the Commission’s approach to further regulate new technologies mentioned in its European Strategy for Data and agrees that there is a need for an agile approach. Regulatory framework will require much quicker adaptation in the coming years so that people can have a timely benefit from digital progress. Technological acceleration needs to be paired with future-gazing regulation to ensure their on-time availability on the market without safety or security issues. // Usable data needs to be quality data – going beyond interoperability Although there is a commendable focus on interoperability in the European Commission Roadmap, AESGP believes that this effort should be balanced with investigation on the quality of data. Data capture is a key element that should only be performed by validated tools which can, in turn, be evaluated and guarantee data comparability. // From data storage to custody – responsibilities and access AESGP calls for more harmonization of data storage responsibility and access while welcoming the vision and willingness to create a common EHDS. AESGP further calls for more support of the legislation in data sharing and Industry access to anonymized data under defined conditions. // Real World Data (RWD) benefits – translating potential evidence to favourable health outcomes It is very relevant that the regulatory framework for a EHDS makes data-sharing ecosystems work, while harnessing the potential for favourable health outcomes, like the opportunity for RWD collection and analysis. RWD can provide additional data to support the decision-making process also in population groups that are usually not covered by clinical trials. The use of RWD should ensure that healthcare products, innovative technologies and therapies meet patients’ needs and lead to favourable health outcomes. // Empower people’s health and digital literacies for a better future AESGP would highlight that there are important needs in the training of both healthcare and digital experts, so that the ability to work cross functionally is enhanced. AESGP believes it important to train people specialized in the field of artificial intelligence or data science, as well as to give basic training to the general population. Having everyone digitally and data literate will ensure responsible and adequate use of digital tools and build trust in the system. AESGP would like to call for more data applications to unleash the potential of this massive amount of data while guaranteeing the safety and security of European citizens. (Please read full opinion in attachment)
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

The Association of the European Self-Care Industry (AESGP), representing the European manufactures of consumer healthcare products (including non-prescription medicines and selfcare medical devices), would like to use the opportunity provided by the Commission to comment on the draft Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (2020/0321 (COD)). As part of the healthcare continuum, self-care products can prevent illness, address minor health problems, reduce pressure on health systems, and its use was an essential part of facing the COVID-19 pandemic. Self-care entails responsible self-assessment, self-treatment and self-monitoring, only possible by consumer and patient empowerment, by increased health literacy and by professional guidance on healthy lifestyle choices. AESGP acknowledges that the EU must have all the tools and governance in place, including at high level, to build a stronger European Health Union, and ensure resilience and coordinated actions to face future health emergencies. The role of existing EU agencies, such as the European Medicines Agency (EMA), should be further reinforced not only with greater competences but also with sufficient allocation of resources in terms of staff and funding. In line with this Commission’s commitment for a sound and flexible regulatory system, AESGP agrees that it is crucial to pursue a better regulation agenda for a modern pharmaceutical sector, to reduce red tape and improve access and timelines, after an impact assessment that addresses the specificities of the assorted range of medicinal products and medical devices. AESGP fully supports the general objectives of the proposal to (1) ensure a high level of human health protection by strengthening the Union’s ability to manage and respond to public health emergencies, which have an impact on medicinal products and medical devices, and (2) contribute to ensuring the smooth functioning of the internal market for such products during public health emergencies. Nonetheless, AESGP would like to share its significant concerns on the draft proposal, as detailed in the attached document, for consideration by the Commission and ask for: - an impact assessment to accompany this legislative proposal; - where appropriate, a revision of the draft proposal to address the concerns raised in the attached document.
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Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

6 Nov 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Meeting with Stella Kyriakides (Commissioner) and

30 Sept 2020 · Call with pharmaceutical and medical device supply Chain on COVID-19

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

AESGP welcomes the Roadmap for the Pharmaceutical Strategy, ensuring sustainable innovation and the availability and affordability of medicines and medical technologies for citizens. This is the Executive Summary of the attached AESGP's reply: 1. There is an important role for Self-Care pharmaceuticals and health literacy in the over-arching aim for healthcare system sustainability + Self-care aims at promoting and maintaining a healthy status, by preventing disease, addressing temporary or recurrent symptoms, illness or disability, saving unnecessary visits to overburdened healthcare systems and strengthening citizens’ autonomy + Health literacy and prevention can lead to better health outcomes + Change of legal status from prescription to non-prescription could increase opportunities for better healthcare management + Real-world evidence can strengthen benefits and safety of non-prescription medicines 2. A healthy competitive market and a resilient supply chain helps to ensure worldwide success of European Pharmaceutical sector for non-prescription medicines + Pharmaceutical sector in Europe is vital for the European growth and prosperity + Self-care market is characterised by healthy competition due to the high number of options + Keep competitive level playing field and proportional legislation, so crucial for business certainty and to attract investment 3. European production and procurement need to rely on global supply chain sustainability to reduce effects of eventual medicines’ shortages + Europeans benefit from access to large span of affordable self-care products, including non-prescription medicines + Globalisation of the supply chain is a success and ensures exports + There is no evidence that onshoring manufacturing will resolve shortage problems as it’s also a protectionist measure + Europe needs to address root-causes of shortages while balancing with reliance on affordable products from third countries + Establishment of medicines reserves as structural stockpile should be commensurate to the product risk level + Regulatory flexibility that proved useful during the COVID19 crisis, could also be applied in other cases or be maintained in a post-pandemic scenario 4. Environmental concerns need to be paired with accessibility and affordability of medicines + Symptomatic relief with self-care products in viral infections helps to avoid antibiotics misuse and reduce AMR + Pharmaceutical Industry has leading examples in greener practices for manufacturing operations + Industry is addressing the data gaps for the potential impact of Pharmaceuticals in the Environment to pave the way for effective mitigation measures + Unused and expired medicines are target for collection schemes supported by industry under Producer Responsibility Organizations and the European level #MEDSdisposal project. + Measures aimed at reducing pharmaceutical residues in the environment must not jeopardize patients’ rights to access to the appropriate treatments 5. Smart regulation can be a way forward to increase accessibility and availability of pharmaceuticals to patients + Consideration should be given to facilitating and encouraging the change of legal status of medicines, to ensure greater access and availability of pharmaceuticals to patients + Flexibility and risk-based decisions, adjusting some regulatory practices and reducing unnecessary burden, can help ensure continuity of product availability + The pharmaceutical industry calls for modernisation of the current variations system to reflect the evolution in technology and regulatory needs and chages in patient behaviours, both on- and offline 6. Protecting Pharmaceutical SMEs and allowing for special regulatory provisions is to safeguard important sources of innovation + Incentives should be tailored to SMEs to improve innovation, including better regulation and removal of administrative burden + Harmonised, risk-based and pragmatic implementation of the legislation
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Meeting with Stella Kyriakides (Commissioner) and

29 Jun 2020 · Call with pharmaceutical and medical device industry associations on COVID-19

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Jun 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

29 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

15 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Response to Initiative prohibiting and permitting under scrutiny certain hydroxyanthracene derivatives in food supplements

23 Apr 2020

The Association of the European Self-Care Industry (AESGP) appreciates the opportunity provided by the Commission to comment on the draft Commission Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (HAD). AESGP would like to share the key concerns on the draft Commission Regulation for consideration by the Commission and the national competent authorities and ask for a revision of the draft to address these concerns. The comments are elaborated in the attached document.
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Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

17 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Response to Farm to Fork Strategy

16 Mar 2020

The Association of the European Self-Care Industry (AESGP) welcomes the opportunity to provide feedback to the European Commission Roadmap “Farm to Fork Strategy”. AESGP is supportive of this European Commission initiative in securing a fair, healthy and environmentally-friendly food system, from production to consumption, in it’s Farm to Fork strategy interlinking it with the objectives of the European Green Deal. AESGP recognizes the efforts of the European Commission in taking a leading role in its commitment to the United Nations Sustainable Development Goals and the implementation of food related targets through the Farm to Fork Strategy. In particular, the free movement of healthy and wholesome food is an essential aspect of the internal market and contributes, among others, significantly to the health and well-being of consumers. AESGP welcomes the European Commission approach to addressing the challenges faced by the food system in Europe and working towards ensuring the sustainability of these food system(s). We consider that looking into the various dimensions of the sustainability concept including its social impact is important in order to fully achieve this. Looking at these challenges holistically, focusing also on health and nutrition, may in addition help to address other challenges which are significantly interlinked with food systems, such as the sustainability of health systems. The initiative presented aims to develop a coherent policy and regulatory framework for stimulating research and innovation to create sustainable food systems and market opportunities. We fully stand behind the science-based approach in food policy and would like to highlight the importance of a scientific basis comprehending available scientific information and data as a crucial element in developing both regulatory and non-regulatory initiatives envisaged in the Roadmap. AESGP supports the Commission’s aim to help consumers choose healthy and sustainable diets by providing better food information to suit individual needs. The improvement of food information in this regard will allow consumers to make better-informed food and dietary choices, especially for those consumers who have special nutritional needs. We further acknowledge the importance of consumer empowerment which we consider plays a decisive role in healthy lifestyles and behaviours, which can address contemporary patterns of consumption. However, we would like to note the importance of proportionate implementation of existing legislation and ensuring that new initiatives under the strategy are fit-for-purpose, taking also into account the specific rules which are applicable to specific food categories, and evidence based.
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Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

13 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Anne Bucher (Director-General Health and Food Safety)

9 Sept 2019 · introduction of AESGPand activities, namely in the area of pharmaceuticals, food supplements; public health issues such as AMR; sustainability of health systems

Response to Transparency and sustainability of the EU risk assessment model in the food chain

25 Jun 2018

AESGP fully supports the proposal’s objective to improve the citizens’ trust in the EU risk assessment in the food chain by improving its transparency and sustainability. As an EFSA registered stakeholder, AESGP has always been supportive of the effort thus far taken by EFSA to implement the existing transparency provisions of the General Food Law (GFL) and to further increase its transparency and openness through its “Open EFSA” programme, as long as an effective protection of Confidential Business Information (CBI) was guaranteed. We acknowledge efforts introduced in the proposal to increase consumers’ confidence in the overall risk analysis process yet would like to point out that, while the proposal refers to both increasing transparency of risk assessment and improving risk communication, it does not address risk management as an essential element of risk analysis. Also, in light of the significant proposed changes to the way EFSA as risk assessor gathers and manages the evidence needed to perform its tasks, it is regrettable that the Commission has decided not to produce an impact assessment of the proposal. - General advice: We certainly appreciate that the calls of business stakeholders for more communication with EFSA have been acknowledged in the proposal. The introduction of general advice at the request of a potential applicant is a welcome contribution to the enhanced interaction between applicants and EFSA as long as the publication requirement that would apply to such advice does not endanger the business strategy of the future applicants. - Transparency: AESGP acknowledges the decision to strengthen consumer trust in risk assessment process by making all of the commissioned studies and supporting data publicly available. However, we would like to draw attention to the timing of publication as making studies immediately accessible may impede on innovation in the EU and hinder the risk assessment process itself. Thus, we consider that the timing should follow the approach applied by EMA when publishing clinical data for medicinal products for human use. Accordingly, the publication of the nonconfidential parts of the industry studies should take place upon delivery of EFSA's opinion. We have similar concerns regarding the consultations of stakeholders and public, which could positively contribute to the risk assessment process yet should not hinder its scientific basis or delay the process itself. - Confidentiality: Including sufficient guarantees for confidential treatment of commercially sensitive information is of utmost importance for any science-based and innovative industry. We welcome the provisions ensuring confidentiality introduced by the proposal provided their implementation will ensure predictability and, by that, will allow the industry to know in advance if, what, how and when the data submitted will be disclosed to third parties. We would like to reiterate that the new transparency requirements should not negatively impact the right to confidentiality and protection of professional and business secrecy and of property rights which are key for business and industry, as well as for innovation and competitiveness. - Governance, capacity and resources of EFSA: AESGP supports the proposed changes to the governance of EFSA, which will align it with the governance model of other EU agencies. We welcome further involvement of Member States in the governance as well as in nominating members of the EFSA Scientific Panel, while ensuring independence of experts from Member States. The number of new tasks and responsibilities for EFSA introduced by the proposal have the potential to negatively impact EFSA’s already limited resources. Although we acknowledge that the proposal aims at increasing EFSA’s overall budget, we are concerned that it may not be proportionate to the increased workload and may negatively affect EFSA’s efficiency in its primary role as risk assessor.
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Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA

Response to Transparency and sustainability of the EU risk assessment model in the food chain

17 Jan 2018

The Association of the European Self-Medication Industry (AESGP) welcomes the opportunity to comment on the Commission Roadmap on transparency and sustainability of the EU food and feed safety risk assessment model. As a matter of principle, AESGP stands for a policy-making system that is science-based and concur with the conclusion of the Fitness Check of the General Food Law (GFL) confirming that the creation of EFSA has improved the scientific basis of EU measures. AESGP is supportive of this Commission initiative which together with the Fitness Check of the GFL offers an opportunity to evaluate what kind of improvements can be made to increase transparency and trust in the regulatory system while ensuring a strong science base, efficient organisational arrangements and procedures. AESGP also welcomes the initiative as an opportunity for the European Commission to not only tackle the issues introduced during recent public debates, yet also to address other relevant issues which business stakeholders have so far been facing and other shortcomings identified by the Fitness Check. • Transparency AESGP recognizes the effort thus far taken by EFSA to implement article 38 of the GFL and to further increase its transparency and openness through its “Open EFSA” programme. While acknowledging the importance of transparency with regard to the scientific studies supporting risk assessment, we would like to highlight the significance of protecting commercially confidential information and intellectual property details against disclosure and misuse. Any change to the GFL aimed at improving and clarifying the rules on transparency to ensure trust in the regulatory system should not be limited to the risk assessment but address all the components of the risk analysis. Ensuring trust in the regulatory system requires in our view improving civil society understanding of how the whole system works and, as mentioned in the roadmap, developing a more effective and transparent risk communication with the public. • Authorisation procedures AESGP supports a risk assessment that is based on sound science and takes into account the most recent scientific and methodological developments irrespective of the source of funding. Lengthy authorisation procedures have also been identified as one of the shortcomings by the Fitness Check with delays in the risk assessment and the risk management phases and should also be addressed. AESGP would like to underline the importance of communication between the applicants, risk assessors and risk managers during the authorisation process, notably prior the submission of the application, to ensure efficiency of the assessment process in terms of time and resources. • Capacity of EFSA AESGP supports the need to ensure the capacity of EFSA to maintain a high level of scientific expertise across the different areas of the agri-food sector taking into account its related financial and budgetary constraints. In that regard, AESGP welcomes the intention to strengthen scientific cooperation and involvement of Member States in EFSA. AESGP would also consider introducing alternative funding options for EFSA in order to further improve the services provided and increase efficiency. AESGP regrets the timing of the publication of the Roadmap and subsequent consultation period as well as the delayed publication of the results of the General Food Law Fitness Check. Consequently, we were unable to review all findings of the Fitness Check of the General Food Law, consult with our members and present our views on the Roadmap in an appropriate manner.
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Response to Fitness Check of the Water Framework Directive and the Floods Directive

17 Nov 2017

While the pharmaceutical industry (represented by AESGP, EFPIA and Medicines for Europe) supports the objective of the Water Framework Directive (WFD) to protect and enhance freshwater resources with the aim of achieving good quality status of EU waters, we do have concerns as to how it is being implemented in terms of pharmaceuticals in the environment and the potential to impact patient access to medicinal products should those be identified as a risk. Although the benefit of good ecological status of our waterways cannot be overestimated, we believe it is important to achieve this goal but not at the expense of the patients’ access to the medicinal products they need. The risk to the environment should be informed by robust benefit/risk analysis and an overall evaluation that any policy option (such as restrictions on medicinal product access) may have on people. The recognition of this concern and provision for it at policy level would be a welcome addition that can help protect the environment in concert with preserving patient access to medicinal products. In addition, the outcome of the strategic approach for managing pharmaceutical substances in the environment (PiE) called by article 8c of Directive 2008/105/EC (as amended by Directive 2013/39/EU) should be awaited before any selection of active pharmaceutical ingredients (APIs) for the WFD annex or watch list is made in order to avoid potential conflict and/or duplication of efforts for those APIs once the strategy is in place. The pharmaceutical industry as a whole is highly committed to providing concrete solutions to reduce the impact of pharmaceutical substances in the environment and notably on waters, together with all stakeholders concerned and for this purpose, it is working on a strategic approach called Eco-Pharmaco-Stewardship. More specifically, we have concerns about the evaluation of environmental impact of medicinal products in terms of how technical EQS dossiers are being generated. We urge that EQS values are determined based on the availability of standard endpoints which are linked to population sustainability supported by a robust interpretation of the Technical Guidance Document for Deriving Environmental Quality Standards (EQS) (final draft) specifically developed for this purpose and which we ask be soon finalised. In general, we recommend that any standard or criteria being used by the EU to evaluate APIs and environmental impact should be based on widely accepted, validated methodology and robust scientific data. Any methodologies should take into account technical and scientific progress and internationally established guidelines such as Organization for Economic Cooperation and Development (OECD), Good Laboratory Practice (GLP), etc. Technical specifications on pan-European harmonised scientifically robust methods, conforming to European or international standards should be defined and applied by all Member States.
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Response to Qualification of cranberry products to treat or prevent cystitis

28 Mar 2017

The association of the European Self-medication Industry (AESGP) has several concerns related to the draft Commission Implementing Decision that are presented in detail in the enclosed file.
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Meeting with Markus Schulte (Digital Economy)

24 Nov 2016 · digitisation in the medical sector

Meeting with Vytenis Andriukaitis (Commissioner) and

17 Nov 2016 · Roundtable on the future of the General Food Law Regulation

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

17 Mar 2016 · Health Claims legislation

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

3 Feb 2016 · Discussion on self-medecine Industry

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

3 Feb 2016 · Discussion on the non-prescription medicines

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

16 Jul 2015 · Botanicals

Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

9 Jan 2015 · Introductory meeting to discuss the Self-Medication Industry