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Affordable Medicines Europe

Affordable Medicines Europe represents parallel distributors who import medicines across EU borders to introduce price competition.

Lobbying Activity

Meeting with Paolo Inselvini (Member of the European Parliament)

28 Jan 2026 · company presentation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

26 Nov 2025 · Pharmaceutical Legislation

Meeting with Nicola Zingaretti (Member of the European Parliament)

5 Nov 2025 · presentation of the association

Meeting with Michalis Hadjipantela (Member of the European Parliament)

27 Oct 2025 · Meeting about CMA

Affordable Medicines Europe seeks ban on national export restrictions

21 Oct 2025
Topic — EU plan for coordinated prevention, preparedness, and response to cross-border health crises.
Message — They urge the Commission to monitor national actions that restrict cross-border medicine availability. A harmonised EU approach to stockpiling is also needed to prevent market distortions.12
Why — This would eliminate national trade barriers and ensure the free flow of pharmaceutical products.3
Impact — National authorities lose the power to restrict exports through protectionist measures that disrupt supply.4
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Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

Meeting with Marion Walsmann (Member of the European Parliament, Rapporteur for opinion)

26 Sept 2025 · CMA

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

15 Jul 2025 · Pharma Package

Meeting with Dan-Ştefan Motreanu (Member of the European Parliament)

9 Jul 2025 · 'Single Market for Medicines' initiative

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur)

8 Jul 2025 · Critical Medicines Act

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

4 Jul 2025 · Pakiet Farmaceutyczny

Meeting with Sandra Gallina (Director-General Health and Food Safety)

2 Jul 2025 · EU pharmaceutical regulation and policy

Response to Critical Medicines Act

1 Jul 2025

Affordable Medicines Europe welcomes the opportunity to contribute to this public consultation on the Critical Medicines Act (CMA). Our association represents the independent distribution of medicines across the EEA. By moving medicines between countries at lower prices than standard local rates, parallel trade boosts competition, generates savings for patients and healthcare systems, and helps alleviate shortages and increase access to medicines by supplying markets facing availability problems, marketing delays, non-launches, or withdrawals. By using the Single Market to its full extent, we save every year 5-7 billion Euros to European healthcare systems and patients. We welcome the European Commissions proposal for the CMA but believe that several aspects require further emphasis and clarification during the upcoming legislative debate. Internal Market and Free Movement of Goods need to be safeguarded also in the context of the CMA, more strongly than they are now. Measures to strengthen the security of supply must not undermine the functioning of the internal market, and national export restrictions must comply with EU law and avoid negatively impacting medicine availability in other Member States. We welcome the intent of Article 20, but believe it requires additional safeguards to ensure that actions taken to secure supply in one Member State do not negatively impact others or impede the free circulation of medicines within the EU. EU-level coordination and the full use of the internal market should guide national stockpiling strategies. Oversight by EU institutions is essential to monitor and mitigate the unintended cross-border consequences of unilateral national measures. In some cases, such national requirements have created knock-on effects in other Member States, especially smaller ones, by distorting supply flows. As most shortages are not pan-European but occur at national, regional, or local levels, making full use of the internal market and the actors operating in it can already help address supply gaps. Independent distribution serves as a de facto solidarity mechanism within the EU, facilitating the redistribution of medicines from Member States where there is a surplus to where they are needed more. Such redistribution can be done within a very short timeframe, in approximately two weeks. Procurement frameworks must promote transparency, ensure access to relevant information, and uphold competition to avoid further fragmentation of the Single Market. While we support the Commissions efforts to encourage responsible procurement, it is crucial that information held exclusively by Marketing Authorisation Holders such as environmental data is made accessible to all tender participants. Our members have faced barriers due to lack of access to such non-confidential data, undermining fair competition. Article 18 of the CMA should guarantee equal access to relevant information. Additionally, high volume thresholds and long contract durations may exclude smaller players, such as independent distributors. Procurement requirements must be assessed for their impact on competition, and price transparency should be a key consideration in all new frameworks. Finally, coherence in definitions in Article 3 must be ensured. Key definitions in the Regulation should be better aligned with established EU terminology and criteria to ensure legal clarity and regulatory consistency. We are pleased to attach to this feedback our more detailed proposals for amendments to the Commissions proposal.
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Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

1 Jul 2025 · Parallel imports Pharmaceutical legislation

Meeting with Dorota Denning (Cabinet of Commissioner Valdis Dombrovskis)

17 Jun 2025 · Simplification agenda and competitiveness

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

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

4 Jun 2025 · Medicine distribution

Response to Communication on the EU Stockpiling Strategy

9 May 2025

Affordable Medicines Europe welcomes the opportunity to contribute to this public consultation. Our association represents the independent distribution of medicines sector across the EEA. By moving medicines between countries at lower prices than standard local rates, parallel trade boosts competition, generates savings for patients and healthcare systems, and helps alleviate shortages and increase access to medicines by supplying markets facing availability problems, marketing delays, non-launches, or withdrawals. We support the development of a strategic, coordinated EU-level stockpiling strategy to mitigate the risks associated with fragmented national approaches. EU-level stockpiling will facilitate equitable access to medicines across Member States, preventing national hoarding that may have a negative impact on smaller Member States. An EU-coordinated stockpiling system reduces the risk of fragmented national approaches, which could otherwise distort competition and disrupt the Single Market. National stockpiling initiatives have the risk of distorting competition and exacerbating medicine shortages, particularly in smaller Member States. To address these risks, greater emphasis should be placed on fully utilizing the potential of the EU internal market. Independent distributors, who actively trade medicines across the EU/EEA, can play a pivotal role in enhancing supply security by redistributing stocks from regions with surpluses to those facing shortages. It is important to note that independent distribution already serves as a de facto solidarity mechanism within the EU, facilitating the redistribution of medicines where they are needed the most, which is why favourable operating conditions for the sector should be promoted. Enhanced enforcement of the EU internal market rules and freedom of movement must be prioritized in stockpiling, to prevent market distortions and safeguard equitable access to essential medicines across the whole of EU. The COVID-19 pandemic showed the risk of uncoordinated national responses, particularly through the implementation of export restrictions and unilateral stockpiling initiatives. These measures disrupted established supply chains, undermined the principles of the Single Market, and affected the availability of medicines in other Member States that rely on parallel imports to meet demand. Unfortunately, even post-pandemic, several Member States have maintained or introduced new trade barriers in breach of the EU law, further fragmenting the EU internal market and exacerbating medicine shortages. This trend goes against the EUs objective of fostering a well-functioning Single Market and ensuring equitable access to medicines across all Member States. Therefore, we strongly advocate for a coordinated EU-level approach to stockpiling that not only mitigates these risks but also upholds the principles of the Single Market, ensuring that national measures do not negatively impact the availability of medicines in other Member States.
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Response to EU Strategy on medical countermeasures

9 May 2025

We welcome opportunity to contribute to this public consultation. We represent the independent distribution of medicines across the EEA. By moving medicines between countries at lower prices than standard local rates, parallel trade boosts competition, generates savings for patients and healthcare systems, and helps alleviate shortages and increase access to medicines by supplying markets facing availability problems, marketing delays, non-launches, or withdrawals. The COVID-19 underscored the risks of uncoordinated national responses, particularly in the form of export restrictions. Several Member States introduced export bans on medicines, disrupting established supply chains and undermining the principles of the Single Market. Such measures disproportionately impacted the availability of medicines in other EU countries, reliant on parallel-imported products, exacerbating shortages and hindering access to medicines. Additionally, national stockpiling and transportation delays due to closed borders have further limited accessible volumes resulting in an overall decrease in our sectors supply of approximately 20-40%. Moreover, frequent regulatory changes and unclear procurement processes established in some Member States during the pandemic have added to the uncertainty and complexity faced by the sector. The European Commissions COVID-19 guidelines emphasized the importance of maintaining the free movement of goods, a principle that must be reinforced in the context of future public health crises. We therefore urge the Commission to consider establishing a framework that enables the Commission and EMA to monitor and assess national actions whose effect could be detrimental to the availability of medicines in other Member States. Such a mechanism would provide critical oversight to identify unintended consequences of export restrictions and initiate immediate dialogue with Member States, the EMA, and relevant stakeholders to develop alternative measures that maintain supply chain integrity and public health. Similarly, we support the development of a coordinated EU-level stockpiling strategy to mitigate the risks associated with fragmented national approaches. National stockpiling initiatives risk distorting competition and exacerbating medicine shortages, particularly in smaller Member States. To address these risks, greater emphasis should be placed on fully utilizing the potential of the EU internal market. Independent distributors, who actively trade medicines across the EU/EEA, can play a pivotal role in enhancing supply security by redistributing stocks from regions with surpluses to those facing shortages. It is important to note that independent distribution already serves as a de facto solidarity mechanism within the EU, facilitating the redistribution of medicines where they are needed the most, which is why favourable operating conditions for the sector should be promoted. Leveraging existing supply chain networks and tools would contribute to a more resilient and coordinated EU response in times of health emergencies. However, independent distributors ability to harness their full potential is hindered by the gradual erosion of Single Market rules, driven by rising protectionist measures from national governments and a lack of decisive infringement actions by the European Commission. In this context, it is imperative for the Commission to reaffirm its role as the Guardian of the Treaties by addressing enforcement gaps and ensuring strict compliance with Single Market regulations. Enhanced enforcement of the EU internal market rules and freedom of movement must be prioritized, particularly during public health crises, to prevent market distortions and safeguard equitable access to essential medicines across all Member States. The document attached compiles the knowledge gathered by our sector on export restrictions enacted as a response to the COVID-19 crises from March to July 2020.
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Meeting with Dario Tamburrano (Member of the European Parliament)

29 Apr 2025 · Priorità per la legislatura

Meeting with Valentina Palmisano (Member of the European Parliament)

29 Apr 2025 · shortage of medicine

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

25 Apr 2025 · Pharmaceutical products

Meeting with Kristian Vigenin (Member of the European Parliament)

24 Apr 2025 · Ongoing initiatives

Meeting with Ondřej Knotek (Member of the European Parliament, Shadow rapporteur)

24 Apr 2025 · Critical Medicines Act

Meeting with Michalis Hadjipantela (Member of the European Parliament)

23 Apr 2025 · Introductory meeting

Meeting with Kristoffer Storm (Member of the European Parliament) and Pfizer Inc.

9 Apr 2025 · Pharmaceutical Industry

Meeting with Michele Picaro (Member of the European Parliament)

1 Apr 2025 · Pharmaceutical

Meeting with Aurelijus Veryga (Member of the European Parliament)

1 Apr 2025 · Exchange on health policy priorities and potential pharmaceutical reforms in the EU

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

1 Apr 2025 · New EU Pharmaceutical Legislation

Meeting with Tiemo Wölken (Member of the European Parliament)

20 Mar 2025 · Exchange on upcoming Health Policy

Response to Critical Medicines Act

21 Feb 2025

Affordable Medicines Europe welcomes the opportunity to contribute to this consultation. We represent the independent distribution of medicine across the EEA. By moving medicines between countries at prices lower than standard local rates, parallel trade boosts competition, generates savings for patients and healthcare systems, helps alleviate shortages, and increases access to medicines by supplying markets facing availability problems, marketing delays, non-launches, or withdrawals. Medicine shortages have risen significantly, directly impacting our sector. As independent distributors, we rely on surplus supplies after national market needs are met, meaning that increased shortages result in fewer available stocks for import. Combined with regulatory challenges, shortages have led to the decline of our market share in the total EEA pharma market from 3.5% in 2014 to 2.6% today. On another hand, our sector already plays a key role in mitigating shortages that should be further considered in this initiative. As most shortages occur at national or local levels rather than pan-European, in these cases, parallel imports provide a practical solution by redistributing surplus stocks across countries. About the initiative's scope, as reported by EFPIA/IQVIA, in-patent medicines account for only 4% of reported shortages, indicating that most shortages affect generics. Furthermore, 90% of reported shortages of Critical Medicines pertain to generics, as highlighted in the Draft Report of the Critical Medicines Alliance. Therefore, we believe the Acts focus and the proposed solutions should primarily target this area of medicines. Concerning investments, we advocate for EU-level investments over national incentives to address structural shortages. A coordinated European approach better preserves internal market integrity and fosters strategic autonomy. National incentives risk market fragmentation and disparities. Pharmaceutical companies leveraging investment for regulatory concessions (as seen in Germany with Eli Lilly & Co. that reportedly conditioned its 2.3 billion investment in Germany on changes to national legislation regarding the confidentiality of medicine prices) undermine competition and impose societal costs. We support harmonized contingency stock frameworks and stronger EU coordination to prevent market fragmentation. While a solidarity mechanism between Member States is a positive idea, practical challenges arise due to supply chain ownership structures. Member States do not own medicines; wholesalers do. Instead, maximizing the Single Markets potential and leveraging independent distributors should be prioritized. Parallel trade already acts as a de facto solidarity mechanism, redistributing medicines efficiently. Independent distributors can quickly repackage medicines to meet national requirements and deliver them where needed within two weeks. However, the rise of protectionism, marked by increasing export restrictions, and lack of enforcement of EU rules, has undermined this potential. Public procurement significantly influences pharmaceutical market dynamics. We support the Alliances recommendations to promote responsible procurement. We believe though it is essential that any information required in the procurement process, which is exclusively available to the MAH, should also be made available to other players in the tender who do not have direct access to this data. Currently, parallel distributors face challenges in obtaining environmental and other data required in tenders, while MAHs hold a monopoly over this information. Without equal access to this information, competition is undermined. Procurement policies should also consider market access impact. High volume requirements and long contracts may limit competition and exclude market players like independent distributors. Procurement policies should consider that secret price agreements in several EU countries already severely restrict competition.
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Meeting with Ingeborg Ter Laak (Member of the European Parliament)

4 Feb 2025 · Medicine shortages

Response to Single Market Strategy 2025

30 Jan 2025

Affordable Medicines Europe welcomes this European Commission's call for evidence and values the opportunity to contribute. We represent the independent distribution of medicines across the EEA. Our sector has long played a pioneering role in shaping the Internal Market, serving as its ultimate expression. By moving medicines between countries at prices lower than standard local rates, parallel trade boosts competition, generates savings for patients and healthcare systems and helps alleviate shortages and increase access to medicines by supplying markets facing availability problems, marketing delays, non-launches, or withdrawals. The significant rise in medicine shortages has intensified the political pressure around this issue. This has fueled a politically driven narrative, which has often hindered a clear understanding of the market and resulted in measures that are not always the most effective for addressing the problem. Indeed, many EU member states have adopted increased trade barriers to restrict parallel exports of medicines, leading to a re-fragmentation of the EU internal market. Our response highlights these critical issues, supported by evidence and examples in the attached document, and outlines some concrete proposals to overcome those problems. These export bans often violate Articles 3436 TFEU and fail to meet the criteria required by the European Commissions 2018 paper on the obligation of continuous supply to address medicine shortages. Instead, they seem politically driven, aimed at protecting the commercial interests of Marketing Authorization Holders (MAHs) by restricting parallel exports. Currently, 17 of 30 EEA countries impose such restrictions, with at least 10 likely non-compliant and disproportionately applied. Both the OECD and the European Commission have found no evidence linking parallel distribution to medicine shortages. According to IQVIA (2024), only 0.1% of the 8.2 billion packs of generic medicines, where most shortages happen, circulated annually in the EU are parallel distributed, underscoring its minimal impact on the issue. And indeed, export bans have not resolved the problem, as shortages persist even in countries with the strictest restrictions. Weak enforcement of EU laws and the European Commission's lack of infringement actions have exacerbated the problem, undermining the EU Rule of Law, encouraging protectionism, and resulting in losses for EU citizens. Without the rise in export restrictions since 2012, parallel trade would likely have maintained a 3.7% share of the EU pharma market, valued at 9.4 billion instead of 6.6 billion. Economic studies show our sector saves 1 for every 1 of turnover, meaning healthcare payers lose nearly 3 billion annually due to these restrictions. Stronger enforcement of Single Market rules must be a key focus of the 2025 Single Market Strategy. The Commission must ensure full compliance with Single Market rules and efficiently use existing tools (e.g., the 2015/1535 procedure). Enhancing competition will lower healthcare costs and deliver clear benefits to EU citizens. Moreover, improved coordination is essential to prevent individual Member State actions from undermining the Internal Market and disrupting medicine availability. The European Medicines Agency (EMA) and the European Commission should play a central role in collecting data, assessing national measures, and providing oversight to safeguard supply integrity and maintain the Internal Markets functionality. The upcoming revision of pharmaceutical legislation offers a key opportunity to introduce these reforms. Finally, we emphasize the importance and urge the European Commission to push for stricter application by Member States of the May 2018 paper criteria on export restrictions in its forthcoming Single Market Strategy for 2025. This will ensure a more consistent and transparent approach to addressing medicine shortages while safeguarding the integrity of the Internal Market.
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Meeting with Elena Nevado Del Campo (Member of the European Parliament)

30 Jan 2025 · EU Healthcare

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

8 Jan 2025 · Medicines

Meeting with András Tivadar Kulja (Member of the European Parliament)

5 Dec 2024 · Medicines accesibility

Meeting with Lynn Boylan (Member of the European Parliament)

3 Dec 2024 · Parallel distribution of medicines

Meeting with Tilly Metz (Member of the European Parliament)

14 Nov 2024 · Pharmaceutical policy

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

25 Oct 2024 · Dostępność i ceny leków w UE

Meeting with Tomislav Sokol (Member of the European Parliament) and AbbVie and

17 Oct 2024 · Health policy

Meeting with Ondřej Dostál (Member of the European Parliament) and RPP Group and Cepheid Europe SAS

15 Oct 2024 · Introduction

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

14 Oct 2024 · Pharma regulation

Meeting with Oliver Schenk (Member of the European Parliament)

30 Sept 2024 · potential reforms in the health sector

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Bristol-Myers Squibb Company

5 Jan 2024 · Directive on Medicinal products for human use

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

9 Nov 2023 · medicines

Meeting with Ville Niinistö (Member of the European Parliament, Shadow rapporteur for opinion)

26 Oct 2023 · Reform of the EU pharmaceutical legislation

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

23 Oct 2023 · Pharmaceutical Package (Regulation)

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and Novo Nordisk Foundation

23 Oct 2023 · Pharma Revision (staff level)

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

9 Oct 2023 · discussion on the General Pharmaceutical Package revision

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and European Healthcare Distribution Association

26 Sept 2023 · Directive on Medicinal products for human use

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

13 Sept 2023 · Directive on Medicinal products for human use

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

5 Sept 2023 · Pharmaceutical legislation

Meeting with Margrete Auken (Member of the European Parliament, Shadow rapporteur)

31 Aug 2023 · Pharma legislation

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

12 Jul 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and AstraZeneca PLC and Pharma Deutschland e.V

6 Jul 2023 · Revision of Pharmaceutical Legislation (staff level)

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

Meeting with René Repasi (Member of the European Parliament, Shadow rapporteur) and SMEunited aisbl and Independent Retail Europe (formerly UGAL - Union of Groups of Independent Retailers of Europe)

20 Mar 2023 · Binnenmarktnotfallinstrument/ Single Market Emergency Instrument (SMEI) - Staff Level

Meeting with Simon Genevaz (Cabinet of Executive Vice-President Margrethe Vestager)

8 Mar 2023 · Revision of the Pharmaceutical Package

Meeting with Peter Van Kemseke (Cabinet of President Ursula von der Leyen)

7 Mar 2023 · EU pharmaceutical legislation-and discuss specifications the Environmental Risk Assessment (ERA)

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament)

7 Mar 2023 · Pharmaceutical review

Meeting with Joanna Stawowy (Cabinet of Commissioner Janusz Wojciechowski)

7 Mar 2023 · Upcoming revision of the EU pharmaceutical legislation; the critical point of the public service obligation proposed for manufacturers (Article 39(2)); the need for a European level public service obligation; the electronic patient leaflet;

Meeting with Nils Torvalds (Member of the European Parliament, Rapporteur) and European Environmental Bureau and Merck Sharp Dohme Europe Belgium SRL

14 Feb 2023 · Urban wastewater treatment

Meeting with Margrete Auken (Member of the European Parliament, Shadow rapporteur) and BDEW Bundesverband der Energie- und Wasserwirtschaft e. V.

9 Feb 2023 · Recast of the UWWTD

Meeting with Michèle Rivasi (Member of the European Parliament)

2 Feb 2023 · pénurie des médicaments

Meeting with Cristian-Silviu Buşoi (Member of the European Parliament)

25 Jan 2023 · the upcoming revision of the EU pharmaceutical legislation

Response to Informal guidance for businesses on rules for agreements distorting competition and abuse of dominant market position

16 Jun 2022

Dear Sir or Madam, We would like to point out that under the current draft revised text of the Commission Notice on informal guidance there is no possibility for interested third parties to participate in the Commission’s evaluation of the request. The draft only foresees in section IV. 13. that “the Commission (…) may ask (…) IN EXCEPTIONAL CASES, other selected parties to provide supplementary information” (emphasis added). We believe that it is important to strengthen the involvement of interested parties in the Commission´s assessment. Hence, the draft should provide a possibility for input from interested parties when they can be affected by the guidance letter. Even if the guidance of the Commission is informal, it will certainly carry some weight, particularly at the national level and might therefore affect third parties. For example, a pharmaceutical manufacturer might request a guidance letter in relation to a new form of obstacle to parallel distribution. A guidance letter would have direct effect on parallel distribution companies. In that case, Affordable Medicines Europe would like to provide input to the Commission during the assessment of the request. The Commission Notice on informal guidance should therefore foresee the general possibility for comments of interested parties in ongoing assessments rather than only in exceptional cases. Furthermore, in our opinion, there are a number of novel and as yet unaddressed issues in the pharma sector and the Commission should focus its efforts on issuing binding infringement decisions where necessary. The invitation to possibly infringing pharmaceutical manufacturers to request informal guidance letters should play a minor role as it is not an effective tool to tackle the existing issues in the pharma sector. With kind regards, Olga Ruppert Senior Legal Advisor Affordable Medicines Europe
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Response to Single Market Emergency Instrument (SMEI)

9 May 2022

Affordable Medicines Europe welcomes the European Commission’s proposal of a new Single Market Emergency Instrument aimed to guarantee the free movement of goods, services, and people, with greater transparency and coordination during crises. Parallel distribution of medicines is an integral part of the medicines supply chain in the Single Market, and it is strictly anchored to the principle of free movement of goods. As a sector, we, therefore, acknowledge the key role played by the Single Market in strengthening the EU’s resilience and the competitiveness of our economy. In the context of the COVID-19 pandemic, our Single Market has proved to be a key asset in managing crisis. However, it has also been severely tested by supply restrictions, border closures, and fragmentation. During the first wave of the COVID-19 crisis, a vast number of Member States introduced hastily made emergency export bans on medicines. This has severely impacted our business and resulted in a negative effect on our turnover of around 10-20% during the first 2-3 months of the pandemic. The costs were felt somewhat uneven on the export side (primarily affecting countries imposing bans), whereas on the importing side, the effects were felt by all importing countries (20+ Member States have established parallel import markets). Furthermore, stockpiling requirements on medicines in some countries exacerbated the problems - acting as de facto export restrictions (usual export volumes were not allowed to leave the countries). Finally, some of our members were negatively affected by restrictions on the free movement of persons and services in relation to workers operating in border areas, and cross-border service providers. Worse yet, was the fact that export restrictions led to shortages of medicines in a number of Member States dependent on imports for given products. This could both be smaller Member States like Malta and Cyprus relying on unlicensed imports (Articles 126a or 5 of Directive 2001/83), the Baltics relying for some products on launching of products only from parallel import/distribution companies, or Member States with large parallel import/distribution volumes for given products/treatments. We estimate, for our sector, that around 5-10 shortages per Member States in about 15 Member States materialised within the first month of the COVID-19 pandemic as a consequence of unjustified export bans on non-COVID-19 related products. The COVID-19 crisis clearly highlighted just how detrimental such restrictions can be to the ordinary and long-standing medicine supply chains. The free movement of medicines is a key aspect in ensuring patient access to all Europeans and, therefore, Affordable Medicines Europe would support every effort to ensure that the free circulation of goods, services, and persons is to some extent preserved also during an emergency. Our association acknowledges the positive impact of the actions taken at the EU level to mitigate or solving the negative effects of the COVID-19 crisis on the Single Market and, specifically, those aimed at ensuring free movement of goods and an adequate distribution of goods and services of potential relevance to a crisis across the Single Market. These include, inter alia, the creation of green lanes system, as well as the establishment of exemptions from restrictions to free movement for cross-border commuters, strong efforts to keep free movement of goods and free movement for transport and service providers intact. However, it has to be noted that these initiatives sometimes lacked the necessary coordination and appropriate communication channels dedicated to Single Market crisis management between the EU Institutions and Member States. In light of the above, as a sector, we urge the constitution of this new Instrument that would provide reinforced European governance to support policy to anticipate and prevent disruptions and prepare for and respond to future crises.
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Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

20 Mar 2022 · The upcoming revision of the EU pharmaceutical legislation.

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

While we welcome the reforms and actions put forward by the Commission in this strategy, there is also a lack of ambition when it comes to expanding the use of the tools already available in the toolbox. This includes creating a better framework for the parallel import/distribution sector in order to deliver better affordability and access. Our sector has contributed to increased intra-brand competition – not least for on-patent products – and over the past five decades. This is one of the most efficient and proven tools in terms of fostering savings for healthcare payers. Our sector also contribute to alleviating shortages every day. Better utilisation of the regulatory framework and revisions of certain provisions could further foster this. Finally in terms of availability, our sector may contribute by importing to Member States CAP’s where MAH’s otherwise choose not to launch or have deferred launch. This happens already. Likewise, with revised procedures for granting of PI licenses, we could help mitigate the negative effects of MAH commercial withdrawals. In relation to shortages, we consider diversification the key word. Furthermore, we consider it critical to ensure that Europe overall is supplied enough medicines. National PSO's need to be strengthened, and a European overview of supply developed. For the purposes we consider it necessary to revise certain aspects of Directive 2001/83. In order to create greater transparency on prices and pricing, something we consider crucial to ensure better affordability, we suggest the Transparency Directive be revised addressing four key areas in relation to expanding its scope; inclusion of voluntary/secret agreement, inclusion of public procurement, and inclusion of generics. Also, shorter timeframes for price decisions should be considered. The Commission has, over the last years, launched some cases in the pharmaceutical market, notably on excessive pricing and pay-for-delay. However, recently our sector have seen a surge in examples, where Article 102 TFEU, the abuse of dominant market position, in our opinion applies. We have seen evidence of such practices being used by pharmaceutical companies, seeking to fragment the Internal Market, in order to extract the maximum price and profit in each Member State. How-ever, DG COMP seem to have a lack of resources to investigate such cases. We believe this has an impact on the affordability of medicines in the EU. Hence, we believe the Commission should play a much more active role and divert further resources to enforcement of competition rules in the Internal Market. We therefore call on the Commission and DG COMP in particular, to divert more resources to investigations into potential anti-competitive practices by the pharmaceutical sector. Finally, it is in the interest of all citizens and patients alike that we have an environment free of pollutants, toxins, and other substances dangerous to our health. In this decade, where making strides on Climate Policy is no longer optional but urgent, strong environ-mental requirements need to be included in the European Framework for Good Manufacturing Practice. As a positive side effect, enforcing strict environmental standards in the pharmaceutical productions process, could provide incentives to bring at least some medicines production back to Europe (or to countries in EU proximity). This is because it would help level the production-cost differences between Europe and other parts of the World. Any policy proposal on production standards of medicines must integrate green principles into the production process. This in turn should be facilitated through changes to the “Good Manufacturing Practice (GMP)” framework, not through the framework of procurement and distribution.
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Meeting with Cyrus Engerer (Member of the European Parliament)

13 Apr 2021 · European Medicines Authority

Meeting with Eszter Batta (Cabinet of Commissioner Thierry Breton), Pauline Weinzierl (Cabinet of Commissioner Thierry Breton)

2 Feb 2021 · Resilience of the EU pharmaceutical supply chain

Response to Intellectual Property Action Plan

29 Jul 2020

We would like to point out the importance of the continuation of the Community-wide exhaustion regime. EU rules on exhaustion were mainly developed by the European Court’s interpretation of Article 34 TFEU on measures having equivalent effect to quantitative restrictions between Member States. The Court of Justice holds that IP rights are exhausted within the single market once the relevant goods have been put on the EU market (by the right holder or with his/her consent). Therefore, it is important that in the EU, intellectual property rights cannot be used to artificially split up the common market along national borders. The legislative framework should make sure that the holder of an IP right in a Member State cannot oppose the import of a product protected by the IP right into that Member State, when that product was already put on the market in another Member State by the holder or with his consent. Furthermore, we want to address the issue of future application of the Specific Mechanism. The Specific Mechanism is as an exception to the principle of exhaustion. Its purpose is to balance effective protection of patent rights and the free movement of goods. The Specific Mechanism as laid down in the Accession Treaty dated 16 April 2003 is not applicable anymore as it has expired on 31 December 2019. Hungary had introduced a patent on pharmaceutical products on 1 July 1994 as the last accession country. A patent is limited to a maximum of 20 years, plus 5 years of possible supplementary protection and 6 months of possible pediatric extension. Hence, after 25,5 years at the latest the applicability of the Specific Mechanism ends. Currently, there are difficulties regarding the interpretation of the Specific Mechanism which lead to increased costs and extra workload for patent holders, parallel traders and authorities. Since the Specific Mechanism provides an exemption of the single market rules, it should be interpreted strictly and no further application, e.g. for second medical use cases should apply. We therefore call for a clear system – like in the accession treaty of Spain and Portugal – with - a clear fixed date for the transition period - a clear definition of the protection = only product patents (no use-patents, formulation patents, second medical use patents etc.) - no notifications – neither to patent holder nor to authorities.
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Meeting with Kaius Kristian Hedberg (Cabinet of Commissioner Elżbieta Bieńkowska), Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska) and European Healthcare Distribution Association

28 Aug 2018 · pharma sector - medicines

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

18 Jul 2018 · Parallel import of medicines

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

13 Oct 2017 · Parallel trade

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

8 Dec 2016 · new export ban list Poland

Meeting with Vytenis Andriukaitis (Commissioner) and

11 Jul 2016 · Shortages of medicines

Meeting with Ladislav Miko (acting Director-General Health and Food Safety)

18 May 2015 · Trade in drugs

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

6 Mar 2015 · Falsified medicines