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European Healthcare Distribution Association

GIRP

GIRP represents over 500 pharmaceutical wholesalers across 33 European countries, distributing medicines and healthcare products to serve patients' needs.

Lobbying Activity

GIRP urges EU to simplify medical device sampling rules

6 Oct 2025
Topic — The European Commission is reviewing rules to simplify medical device safety requirements.
Message — The association requests a risk-based approach that limits sampling to cases where reasonable suspicion occurs. They also call for harmonized risk classifications to resolve conflicting tracking obligations for medical devices across Member States.12
Why — This would reduce operational costs and prevent the unnecessary destruction of products.34
Impact — National regulators would lose the authority to perform routine, non-suspicion-based safety inspections.5
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GIRP demands fleet exemptions to protect vital medicine deliveries

8 Sept 2025
Topic — The Commission is consulting on mandatory zero-emission targets for corporate vehicle fleets.
Message — The association calls for financial subsidies and legal derogations for vehicles requiring specialized temperature control. They advocate for transitional solutions like hybrids and an implementation timeline extending past 2030.123
Why — Special treatment would protect narrow profit margins and ensure operational viability.456
Impact — Patients risk health consequences if rigid rules disrupt life-saving medicine deliveries.7
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Meeting with Laurent Muschel (Director Health Emergency Preparedness and Response Authority)

2 Sept 2025 · Market developments; stockpiling

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and MedTech Europe

1 Jul 2025 · Health policy

Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs and

13 Jun 2025 · Critical Medicines Act

Response to EU Strategy on medical countermeasures

9 May 2025

GIRP, the European Healthcare Distribution Association, welcomes the European Commissions initiative to develop a Strategy to support Medical Countermeasures (MCMs) against public health threats. As critical infrastructures, pharmaceutical full-line wholesalers play a pivotal role in ensuring the availability and accessibility of medicines and other health products, both in normal times and during crisis. GIRP represents the national associations of over 500 pharmaceutical full-line wholesalers operating across 33 European countries, alongside major pan-European and international healthcare distribution companies. These wholesalers ensure a timely, equitable, and cost-effective availability and accessibility of healthcare products throughout the EU. As the only operators that distribute the full range of medicines required by patients and healthcare professionals, they are vital to the functioning of national health systems and the EU internal market. We fully support the objectives of the Preparedness Union Strategy and acknowledge the importance of a comprehensive MCM strategy. Recent events from the COVID-19 pandemic to the war in Ukraine have exposed vulnerabilities in the supply of critical medical countermeasures (ex: vaccines, antibiotics, personal protective equipment, medical devices...) Enhancing the legal framework and improving access to medical countermeasures are essential to strengthen EU preparedness and ensure the continuity of vital healthcare services in times of crisis. To this end, GIRP urges the European Commission to integrate the following 3 principle in the incoming strategy to support medical countermeasures against public threats. Please find GIRP's contribution attached.
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Response to Communication on the EU Stockpiling Strategy

9 May 2025

GIRP, the European Healthcare Distribution Association, welcomes the forthcoming publication of the EU Stockpiling Strategy. As critical infrastructure, pharmaceutical full-line wholesalers consider the strengthening of supply chains a cornerstone of the European Unions efforts to increase preparedness and resilience in the face of future crises. GIRP represents the national associations of over 500 pharmaceutical full-line wholesalers operating across 33 European countries, alongside major pan-European and international healthcare distribution companies. These wholesalers ensure the availability and accessibility of healthcare products in a timely, equitable, and cost-effective manner throughout the EU. As the only operators that distribute the full range of medicines required by patients and healthcare professionals, they are vital to the functioning of national health systems and the EU internal market. We fully support the objectives of the Preparedness Union Strategy and acknowledge the importance of resilient supply chains and strategic reserves in strengthening the EUs crisis response capacity. Recent events from the COVID-19 pandemic to the war in Ukraine have exposed vulnerabilities in the supply of critical goods, particularly medicines. Establishing well-managed safety stocks for essential medicines is a key element in improving the EUs preparedness and ensuring the continuity of vital healthcare services. To this end, GIRP urges the European Commission to integrate the following four principles into the design of the forthcoming stockpiling framework. Please find attached GIRP contribution.
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Meeting with Boriša Falatar (Cabinet of Commissioner Hadja Lahbib)

6 May 2025 · health-related preparedness and stockpiling

Meeting with Stine Bosse (Member of the European Parliament)

21 Mar 2025 · European health policy

Healthcare distributors urge EU funding for medicine supply resilience

27 Feb 2025
Topic — A legislative proposal to tackle medicine shortages and strengthen European pharmaceutical supply chains.
Message — The association requests financial incentives and funding to support wholesalers as critical infrastructure. They also propose harmonized stockpiling and rules to ensure equitable distribution through wholesale channels.12
Why — Subsidies and service fees would compensate wholesalers for the costs of distributing low-margin medicines.3
Impact — Manufacturers could face restrictions on direct-to-pharmacy sales and new costs for mandatory stockpiling.45
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Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

10 Feb 2025 · Pharmaceutical strategy for Europe

Meeting with Olivér Várhelyi (Commissioner)

6 Feb 2025 · Role of full line wholesalers in the safe supply of medicines in the EU

Meeting with Rainer Becker (Director Health and Food Safety)

7 Jan 2025 · Exchange of views on pharmaceutical policy

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

1 Mar 2024 · Exchange of views on the security of supply in the EU.

GIRP Urges Mandatory Drug Supply to Wholesalers to Curb Shortages

8 Nov 2023
Topic — Revision of EU pharmaceutical laws to ensure affordable medicine and supply security.
Message — GIRP requests mandatory manufacturer supply to wholesalers to prevent distribution bypasses. They advocate for harmonized terminology and oppose using the European Medicines Verification System.12
Why — This ensures wholesalers maintain product access and prevents exclusion from pharmaceutical distribution channels.34
Impact — Pharmaceutical manufacturers lose the flexibility to select specific distributors or bypass wholesalers entirely.5
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Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

4 Oct 2023 · Meeting of Cabinet Kyriakides with GIRP the EU Healthcare Distribution Association on the pharma revision and shortages

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Affordable Medicines Europe

26 Sept 2023 · Directive on Medicinal products for human use

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

7 Jul 2023 · Directive on Medicinal products for human use

Meeting with Maria Luisa Llano Cardenal (Cabinet of Vice-President Margaritis Schinas)

22 Mar 2023 · Revision of the Pharmaceutical legislation

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

22 Mar 2023 · Exchange of views on the upcoming pharmaceutical reform

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

16 Nov 2022 · Lessons learned on impact of COVID-19 pandemic

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

28 Jun 2022 · VTC meeting: Exchange of views on the upcoming pharmaceutical legislation

Response to Single Market Emergency Instrument (SMEI)

11 May 2022

GIRP welcomes the initiative of the European Commission to adopt legislative and non-legislative measures to implement a flexible and transparent mechanism to strengthen the resilience of the European single market. As a cornerstone of the European Union, the Single Market and the freedom of movements of goods is a key component of the ever closer Union that impregnates the spirit of the Treaties. As such, GIRP urges the European Commission to adopt an adequate policy and regulatory framework to ensure a robust and competitive Single Market that possesses the tools to anticipate and deflect the future threats and crises, and to build on the lessons learnt from the COVID-19 crisis and the recent invasion of Ukraine by Russia. In this regard, GIRP salutes the initiative of the European Commission to adopt a Single Market Emergency Instrument (SMEI) and welcomes the similarity between the policy options envisaged by the European Commission for the SMEI and the framework already established for HERA as a testimony of the learnings from the COVID-19 pandemic. Indeed, the COVID-19 crisis has profoundly changed the way that the European Union, the Member States and the stakeholders respond to crises, together. These new situations gave rise to an unprecedented co-operation that highlighted the necessity to put at the core of the future policies of the European Union a multi stakeholder approach. For this reason, GIRP insists on the necessity of a flexible and transparent framework that fosters co-ordination and communication and ensures guidance on emergency and crisis management measures. Representing full-service healthcare distributors, GIRP and its members have been on the frontline of the COVID-19 pandemic and have adapted at record speed to the crisis to ensure the timely, adequate, and continuous supply of medicines for patients all over Europe. In so doing, GIRP and its members faced a number of issues that could be resolved by the adoption of an adequate SMEI. Firstly, due to the closing of national borders at the start of the COVID-19 pandemic, full-service healthcare distributors were faced with situations in which delivering medicinal products was made almost impossible. GIRP strongly believes that the restriction to the free movement of i.a. goods within the Union in times of crises should not apply to essential and critical sectors, and all the more when the said movement within the Union aims to provide medicinal products to patients at risk. Secondly, more than the closing of national borders, full-service healthcare distributors encountered, in particular at the start of the crisis, export bans and export restrictions that severely impacted the availability of medicinal products throughout the Union and jeopardised the health of European Patients. GIRP regrets such detrimental situation and calls on the European Commission to facilitate the movement of medicinal products managed by full-service healthcare distributors, in particular in light of the existing guidelines on the export restrictions as per the Paper on the obligation of continuous supply to tackle the problem of shortages of medicines agreed by the Ad-hoc technical meeting under the Pharmaceutical Committee on shortages of medicines on 25 May 2018. Thirdly, full-service healthcare distributors are often faced, in particular in times of crisis, with unjustified regulatory inflexibility from the Member States and lack of guidance and communication on both the EU and national level, that considerably slowed down the efforts of the sector to deliver medicines and adapt its supply chain to crisis mode. GIRP calls on the European Commission to establish an agile and swift regulatory framework that allow targeted and proportionate flexibility to ensure a timely and adequate supply of medicines throughout European Union Member States. GIRP welcomes once again the possibility to comment on the initiative for an SMEI and awaits further constructive dialogue.
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Meeting with Andreas Glück (Member of the European Parliament, Committee chair)

5 May 2022 · Covid19-Pandamic

Meeting with Margaritis Schinas (Vice-President) and

18 Oct 2021 · Health in the EU

Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Response to Good distribution practice for active substances for veterinary medicines

9 Jun 2021

GIRP welcomes the opportunity to comment on the revised drafts of the "COMMISSION IMPLEMENTING REGULATION (EU) .../... of XXX as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6. GIRP member associations and products for human use in compliance with the regulatory requirements of the EU-GDP Guidelines with medicinal products for human use. In addition, some GIRP members supply pharmacies and veterinarians with starting materials for veterinary medicines. We warmly welcome the approach of the European Commission in their draft implementing regulation on European Commission Implementing Regulation (EU) .../... of XXX as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 to avoid unnecessary administrative burdens and costs, as wholesale distributors store and deliver human and veterinary medicines and some of them also starting materials for veterinary medicinal products, it is therefore not practicable to deviate from the GDP Guidelines of 19 March 2015 on active substances for medicinal products for human use. In order not to adversely affect the availability of starting materials for veterinary medicinal products, no more stringent requirements should be imposed on GDP for active substances used as starting materials in veterinary medicinal products other than those that already hold for active substances for medicinal products for human use. In this respect, we kindly ask you to take into consideration the following comment: Alignment with Good Distribution Practices for active substances used as starting materials in for medicinal products for human use Physical and/or electronic segregation of products GIRP invites the Commission to reassess the relevance of the dual requirements of physical and electronic segregation of products as foreseen in the current Article 15(5). GIRP invites the European Commission to align the measures on GDP for active substances used as starting materials in veterinary medicinal products with the GDP for medicinal products for human use insofar as the latter always provides for physical or electronic segregation and that except the current Article 15(5), all the provisions of the GDP for active substances used as starting materials in veterinary medicinal products incorporate the alternative condition as regards segregation of products. GIRP invites the Commission to amend Articles 15(5) and to replace ‘physically and electronically’ by ‘physically or electronically’.
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Response to Good distribution practices for VMPs

8 Jun 2021

GIRP welcomes the opportunity to comment on the revised drafts of the "COMMISSION IMPLEMENTING REGULATION (EU) .../... of XXX on measures on good distribution practice for veterinary medicinal products". GIRP member associations and companies undertake considerable efforts to fulfil their legal obligation to ensure the supply of the population with medicinal products for human use in compliance with the regulatory requirements of the EU-GDP Guidelines with medicinal products for human use. In addition, GIRP members supply pharmacies and veterinarians with veterinary medicines. We warmly welcome the approach of the European Commission in their draft implementing regulation on measures on good distribution practice for veterinary medicinal products to avoid unnecessary administrative burdens and costs, as wholesale distributors store and deliver human and veterinary medicines. It is therefore not practicable to deviate from the GDP Guidelines on Good Distribution Practice for Medicinal Products for Human Use (2013/C 343/01) for veterinary medicinal products. In order not to adversely affect the availability of veterinary medicinal products, no more stringent requirements should be imposed on GDP for veterinary medicinal products, other than those that already in place for medicinal products for human use. In this respect, we kindly ask you to take into consideration the following comments: Alignment with Good Distribution Practices of medicinal products for human use Physical and/or electronic segregation of products GIRP invites the Commission to reassess the relevance of the dual requirements of physical and electronic segregation of products as foreseen in the current articles 12(6), 12(7), 25(1), and 31(2) insofar as the possibility to recourse to sole electronic segregation ensures at least the same level of quality and security of the products according to Article 3(2) of the GDP of medicinal products for human use. GIRP invites the European Commission to align the measures on GDP for veterinary medicinal products with the GDP of medicinal products for human use and always provide for physical or electronic segregation. GIRP invites the Commission to amend Articles 12(6), 12(7), 25(1) and 31(2) and for each of these provisions to replace ‘physically and electronically’ by ‘physically or electronically’. Returned veterinary medicinal products GIRP invites the Commission to reassess the relevance of the requirement of the production of records of temperature readings during transport in the case of returned veterinary medicinal products as foreseen in Article 30(3)(f) insofar as such records are not available in the case of so-called passive deliveries and would potentially reduce access to veterinary medicines. In addition, such requirements are too stringent considering the use of veterinary medicines and are unnecessarily stricter than the requirements in the case of GDP of medicinal products for human use where no such conditions are stated. GIRP invites the Commission to delete Article 30(3)(f). Addition of technology GIRP invites the Commission to reassess the relevance of the requirement for additional of technology in vehicles and equipment used to distribute veterinary medicinal products as foreseen in Article 37(4)(b), insofar as such requirements are too burdensome in the case of veterinary medicinal products and would potentially increase the prices of veterinary medicines and possibly reduce their accessibility as medicinal products for human and veterinary use are transported in the same vehicles. In addition, such requirements are not to be found in the GDP of medicinal products for human use. GIRP invites the Commission to delete Article 37(4)(b).
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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

GIRP welcomes the opportunity to comment on the evaluation and revision of the general pharmaceutical legislation by the European Commission (EC). GIRP identifies 4 key areas to improve access to medicines: 1. Ensure through a regulated and enforced framework (with appropriate incentives) the safe, efficient, and fair distribution of medicinal products, and medical devices, to all patients in crisis and non-crisis times. 2. Propose a unified definition for medicine shortages. 3. Address the issue of shortages through identifying their root causes and implementing an EU platform to monitor shortages in cooperation with all Member States (MS) and supply chain stakeholders. 4. Ensure the stable functioning of the healthcare systems through warranting that any revision of legislation accounts for the need for proportionate cost impact on the sector vis-à-vis the intended goals of the revision. 1. Full-service healthcare distributors are the invisible, yet vital link in the healthcare supply chain assuming the timely delivery of all medicines to patients. They are in a unique position to ensure that all health products (incl. vaccines) are distributed safely and fairly across national territories. Throughout the COVID-19 crisis, full-service healthcare distributors have proven their resilience and efficiency in ensuring continuous supply of medicines. They put in place successful contingency plans to respond rapidly to unprecedented levels of demand. Government, customer, and patient confidence in the supply chain at community pharmacy level was maintained. GIRP calls for improved recognition of full-service healthcare distributors’ public service role enshrined in the legislation as they ensure continuous supply, maintain buffer stocks, optimise stock allocation and finance the supply chain. The EC should encourage MS to review their licensing systems and progress towards a EU distribution authorisation regime, differentiating licenses of full-service healthcare distributors (pharmaceutical full-line wholesalers) from other distributors. Full-service healthcare distributors fulfilling Public Service Obligations should be assured the right to be supplied by MAHs. 2. GIRP calls on the EC and MS to adopt of a common definition of medicine shortages, taking the supply and demand on national level into account (e.g. the EMA/HMA definition). GIRP is convinced that patient need is not an appropriate indicator for demand of national markets as many medicinal products have little or no patient need over long periods, although viral outbreaks can cause sudden urgent demand which can only be filled by existing buffer stocks. Adjusting supply according to patient need will lead to acute shortages of essential products. 3. GIRP calls for the interoperation of national shortages databases, allowing cross-country root cause analysis and information sharing at EU level through aggregating data from national early warning systems involving all supply chain stakeholders, including full-service healthcare distributors. GIRP stresses that the European Medicines Verification System (EMVS) is not an appropriate tool for shortages monitoring as it does not contain accurate data of market supply and demand. In some MS, healthcare distributors report market signals to their NCAs, the value of which is undeniable. GIRP calls for transparency to be thoroughly restricted between each supply chain stakeholder and relevant authorities. 4. GIRP calls on the EC to work with MS to support the viability of the full-service healthcare distribution sector as a pillar of EU healthcare systems. The sustainability of the healthcare supply chain must be considered when revising the pharmaceutical legislation as well as the cost impact on the sector vis-à-vis the intended goals. The cost of regulatory compliance has greatly increased in recent years while remuneration has decreased, bringing the distribution sector close to breaking point.
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Response to Enhancement of European policy on critical infrastructure protection

8 Apr 2021

GIRP welcomes the Proposal for a directive of the European Parliament and of the Council on the resilience of critical entities and the harmonisation purpose it serves to apply a uniform approach in identifying critical entities, while also accounting for specificities at national level, including varying levels of risk exposure and interdependencies between sectors and over borders. The COVID-19 crisis has demonstrated the need for a strong and coordinated critical infrastructure at national level to ensure rapid and efficient intervention in the event of cross-border health threats. Full-service healthcare distributors (wholesale distribution authorisation holders, permanently stocking the full range of medicines) are a critical part of the pharmaceutical supply chain and indispensable to ensure safe and reliable access to medicines for citizens, in and out of emergency situations. Based on lessons learned from early days in the crisis, during emergency periods, it is essential that full-service healthcare distributors can maintain staffing levels and services, including the ability to carry out deliveries to and within restricted areas. The critical infrastructure status confers full-service healthcare distributors the means to ensure the stability needed to maintain the necessary activity levels for continued medicines distribution. GIRP members are recognised in most EU Member States as part of the critical infrastructure. That said, this is not systemic, and a number of countries have yet to do so, namely Estonia, France, Lithuania, while our members in Latvia and Slovenia are only partly recognised as critical entity. The proposed legislation will provide for a stable and consistent regulatory framework across EU Member States for the ultimate benefit of citizens. GIRP supports the measures included in the proposal as proportionate and in line with preparedness needs and would like to point out that in many instances, full-service healthcare distributors have already taken security measures to protect their infrastructures and ensure business continuity. GIRP also welcomes the inclusion of requirements for EU Member States to “ensuring the provision in the internal market of services essential for the maintenance of vital societal functions or economic activities, in particular to identify critical entities and to enable them to meet specific obligations aimed at enhancing their resilience and improving their ability to provide those services in the internal market.” GIRP for example recognise as essential the below rights for critical entities (full-line wholesale distributors in the performance of their professional duties) to well function in the context of emergency situations: • Special permits for drivers to access to restricted areas and to travel without limitations • Staff permitted to travel to their work sites (e.g., distribution centres) • Special status for premises to have “rapid decontamination” or deep cleans • Special access to fuel • Staff access to on-duty schools and creches, where possible • Staff access to special funding measures, where possible • Prioritised access to PPE for staff and drivers • Support from army or police, if necessary, for protection of stocks of medicines and medical supplies. Lastly, GIRP fully supports article 5 as an adequate and appropriate measure in the context of cross-border health threats ‘Where an entity has been identified as critical by two or more Member States, the Member States shall engage in consultation with each other with a view to reduce the burden on the critical entity’. GIRP strongly believes that the combination of this proposal with the proposal for a directive of the European Parliament and of the Council on measures for a high common level of cybersecurity across the union constitutes a strong element to the European preparedness plan needed to respond to the current pandemic and to any potential future cross-border health threat.
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Meeting with Margaritis Schinas (Vice-President) and

8 Apr 2021 · Health Union

Response to European Health Emergency Response Authority

22 Feb 2021

GIRP would like to express its appreciation for the opportunity to comment on the establishment process of HERA. We consider HERA to be an important means to effectively and efficiently manage an EU approach to current and future health crisis. We support forming HERA in line with policy option 3 “Full end-to-end Authority for streamlining of EU level initiatives on medical countermeasures for serious cross-border threats to health”. In advance of establishing HERA, careful examination of available policy solutions at national level needs to be carried out to determine what level of intervention at EU level could bring added value to citizens. The following considerations should be studied when determining HERA’s sourcing and stockpiling function: 1. Flexibilities in moving stocks of medicinal products between Member States (MS) The European Commission (EC) should facilitate the movement of stocks managed by full-service healthcare distributors across Europe in emergency situations by pre-emptively setting a framework for swift regulatory flexibility in licencing and labelling rules. 2. Emergency import licences Full-service healthcare distributors and pharmacists should be allowed to import medicinal products from outside the EU at short notice during public health emergencies. The EC should encourage MS to issue emergency import licences at early stages of medicine / medical equipment unavailability to prevent an escalation of the shortage situation. 3. Licencing of medicinal products across the EU The EC should facilitate wider application of licences across the EU in case of public health emergencies. For example, this should be done in a way that would have medicinal products sourced from outside the EU recognised in all MS regardless of the MS where the import originally occurred. 4. Relying on full-service healthcare distributors to optimise stock management Full-service healthcare distributors have the possibility to hold rotating emergency stocks, preventing products from expiring by applying FEFO (first expired first out) principles, through the integration of emergency stocks into normal operations (thereby strictly respecting the agreed buffer quantities), which is a unique capability of our sector. In addition, information on available stock levels and quantities can be made transparent to authorities providing a real-time overview of the supply situation by demand demonstrable. 5. Build stockpiling structure balancing national and European stocks The European stockpile must be built in adequation with existing national stocks. Most Member States already have structures in place, enshrined in Public Service Obligations to ensure a minimum buffer stock level for their country. The EU or regional stockpile should be built on the basis of a list of potentially critical medicinal products to complement the existing buffer stocks and should allow for swift dispatching across the European Union, notably through multi-market packaging or without final packaging. HERA should be provided with the necessary power to act and react quickly to ensure the fast delivery of all medical countermeasures for serious cross-border threats to health to prevent and manage health crises. While an appropriate level of EU and national government and oversight is essential, and the need to interact with regulators and agencies crucial, HERA should be established in a forward looking, flexible, agile and pro-active manner. Its function and decisions should be subject to the highest levels of transparency and accountability to the public directly and not through EU and national governments. Relevant stakeholders should be involved in a supportive / advisory role from the outset.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

GIRP welcomes the proposed regulation on a reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices. GIRP believes that EU coordination is key to addressing the issue of medicine shortages in times of crisis and we are convinced that the EMA is well-fitted to monitor and mitigate potential and actual shortages for the duration of a public health emergency or major event, especially for products considered critical in addressing a given public health emergency. On IT solutions, GIRP proposes that national early warning systems collect market signals from all supply chain stakeholders incl. full-service healthcare distributors to share with NCAs; and meet the following criteria: • Harmonised reporting from the pharmaceutical industry on confirmed and expected shortages including root-causes (to be defined and harmonised) and the APIs • Service-level of the pharmaceutical industry (demand from healthcare distributors against manufacturers’ delivery capacity) • Service-level from healthcare distributors towards dispensing entities (demand from dispensers against healthcare distributors’ delivery capacity) • Entire geographical scope of the Member State to be covered GIRP also recommends further steps at EU level: • Ensure that discussions on using the European Medicines Verification System (EMVS) for shortages monitoring focuses on how to check the information from the EMVS against “real-world availability data on manufacturers stock level” • Make use of existing national systems in place, providing market signals by involving all supply chain stakeholders • Suggest improvements of national systems which do not take market signals into account • Support interoperability between the national systems • Elaborate a method to aggregate data at European level Full-service healthcare distributors are supportive of the provision of relevant information to the NCAs and subsequently to the EMA (Art. 11, paragraph 2). However, GIRP has serious concerns in relation to Art. 9 where reference is made to the information from the points of contact, which should include information from the healthcare distributor and legal persons entitled to supply the medical products to the public. Such coordinated information exchange is potentially anti-competitive. Lastly, it is the duty of the healthcare distributor to hold sufficient stocks to meet shifting needs to ensure a high level of public health protection. Healthcare distributors rely on a consistent and reliable provision of medicines by the MAHs. As such, GIRP calls for the full implementation, effective monitoring and enforcement of Article 81, paragraph 2 of the Directive 2001/83/EC, as amended. Art. 81 Par. 2 should be interpreted and set-out in national legislations in a way that places independent or separate obligations on both MAHs and healthcare distributors. National legislation should also provide for and duly enforce an auditable right to be supplied for healthcare distributors in their capacity as pharmaceutical full-line wholesalers to be appropriately and continuously supplied by MAHs with the full range of products. GIRP is also fully supportive of the creation of the Executive Steering Group on medicines to play a leading role in coordinating the response to shortages during pandemics, as such a framework should reduce the risk of uncoordinated stockpiling of products, ensure the smooth functioning of the internal market and allow for the continued flow of medicines. GIRP endorses the definition of a ‘shortage’ as outlined in the proposed regulation as meaning that supply of a medicinal product does not meet demand for that medicinal product. Whilst the proposed regulation marks an important step in the fight against medicine shortages, additional efforts by regulators and stakeholders alike at systemic level during non-crisis times will be another key pillar in overcoming the challenges related to shortages
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Meeting with Despina Spanou (Cabinet of Vice-President Margaritis Schinas)

12 Nov 2020 · Pharma strategy

Meeting with Stella Kyriakides (Commissioner) and

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

Meeting with Margaritis Schinas (Vice-President) and

29 Sept 2020 · Eu Health Policies

Meeting with Stella Kyriakides (Commissioner) and

28 Sept 2020 · Exchange of views on the upcoming pharmaceutical strategy.

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

3 Jul 2020

GIRP considerations for the Pharmaceutical Strategy for Europe (PSE) GIRP welcomes the European Commission’s (EC) recognition of the pharmaceutical value chain in the Roadmap for a PSE. GIRP looks forward to working with the EU institutions, Member States (MS) and value chain stakeholders to develop concrete solutions for the future of healthcare. Medicines availability and accessibility, taking into consideration the EU single market, lessons learned from COVID-19, national approaches to healthcare, as well as future healthcare organisation are key factors. We need to have an assessment of the challenges and opportunities, to find solutions which incentivise rather than mandate through obligations. Full-service healthcare distributors are the invisible, yet vital link between manufacturers and pharmacies and hospitals assuming the timely delivery of all medicines to patients. They are in a unique position to ensure that all health products (including vaccines) are distributed safely and fairly across national territories. Keys considerations: 1. Recognition of the full-service healthcare distributors’ role GIRP calls for improved recognition of the full-service healthcare distributors’ public service role as they ensure continuous supply, maintain buffer stocks, optimise stock allocation and pre-finance the supply chain. The EC should encourage MS to review their current licensing systems and progress towards a European distribution authorisation regime and the differentiation of full-service healthcare distributors by law. The EC should urge MS, who have not, to include full-service healthcare distributors in their national critical infrastructures. 2. Sustainability of the healthcare distribution sector While the remuneration of healthcare distributors lie at national level, GIRP calls on the EC to work with MS to support the viability and sustainability of the full-service healthcare distribution sector as a pillar of EU healthcare systems. 3. Medicines shortages, accessibility and single market a. Medicines shortages GIRP calls on the EC and MS to agree on the adoption of a common definition of medicine shortage. GIRP calls on the EC and MS to ensure information sharing at EU level through a common medicines shortages database / early warning system involving all supply chain stakeholders. GIRP also calls for the harmonisation of national shortages databases, allowing cross-country root cause analysis and visibility. GIRP stresses that the European Medicines Verification System is not an appropriate tool for shortages monitoring as it does not contain accurate data of market supply and demand. Lastly, shortages monitoring is not within the direct scope of the legislation. b. Medicines availability System failures can be addressed through the full implementation, effective monitoring and enforcement of Article 81, paragraph 2 of the Directive 2001/83/EC in national legislations in a way that places separate obligations on both Marketing Authorisation Holders (MAHs) and healthcare distributors. The latter should have the “right to be adequately supplied” by MAHs to fulfil patients’ needs. Full implementation ensure that appropriate levels of buffer stock are maintained at national level. c. Parallel trade GIRP appreciates the EC guidance (ev_20180525_rd01_en) and encourages swift and determined action in case of disproportionate hurdles to the Single Market. Temporary export restrictions can only be justified in case of products in short apply following strict criteria proposed by the EC. d. EU Single Market for Medicines GIRP calls for the EC to progress with a dialogue on advancing the Single Market for medicines through a forum comprising all supply chain stakeholders and authorities. 4. Digitalisation GIRP calls on the EC and MS to facilitate and incentivise digitalisation to improve healthcare and its distribution including a legislative basis for electronic data interchange amongst supply chain partners.
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Meeting with Kaius Kristian Hedberg (Cabinet of Commissioner Elżbieta Bieńkowska), Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska) and Affordable Medicines Europe

28 Aug 2018 · pharma sector - medicines

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

20 Nov 2017 · Big Data in healthcare

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

14 Dec 2016 · Shortages of medicines