Compulsory licensing of patents in crisis situations
66 submissions from 55 organizations told the European Commission what they think about this file. Here is what each of them said, in their own words.
The Commission lists 169 submissions on this file. Shown here: the 66 from organizations. Not shown, by design: submissions from private individuals, which we never publish, and anything filed since our last weekly refresh.
Approval of the Council’s first reading position by the EP (adoption of the legislative act) · 16 Dec 2025
Signed · 16 Dec 2025
PLENARY_APPROVE_COUNCIL_POSITION · 16 Dec 2025
Plenary Vote · 16 Dec 2025
Who showed up
41 submissions from industry — companies and their trade associations — against 18 from civil society: NGOs, consumer organizations, environmental groups and trade unions. That is 2.3 industry submissions for every one from civil society.
Industry 41Civil society 18Public authorities, academia, other 7
Groupings use the respondent type each organization selected when filing. Counting submissions, not organizations — a body that filed twice is counted twice.
What the room declares
29 of 55
in the EU Register
164
full-time lobbying staff
€21.1M+
declared costs a year
148
EP accreditations declared
Self-declared to the EU Transparency Register (snapshot 2 Sept 2026). The cost figure sums band floors, so the true total is higher.
The file, right now
The consultation closed on 31 Jul 2023 — it ran from 17 May 2023.
The FCIO welcomes the harmonisation of patent law, which focuses on the granting of compulsory licences. Where supply chains cannot provide necessary services/goods in the event of a crisis, government corrective instruments will be supported. However, such an instrument must not pursue other purposes outside crisis management in Europe’s internal market (e.g. forced technology transfers).
Filed in German · English published by the European Commission
Knowledge Ecology International Europe's (KEI Europe) comments on the Commission's proposal for a regulation on compulsory licensing addresses the following issues. The regulation should not be limited to an emergency. The exceptions for regulatory data protections and market exclusivity are important. The exceptions can be implemented under Article 44.2 of TRIPS, more efficiently than under Articles 31 or 31bis.
PhRMA has serious concerns with the ECs proposed regulation to establish a pan-EU compulsory licensing (CL) mechanism for crisis management. Although most respondents during the consultation process supported a coordinating role only for the EU institutions related to CLs, the proposed regulation goes significantly further.
Innovarte ONG, a non-profit focused on a balanced Intellectual Property (IP) regulation system, healthcare accessibility, and the proliferation of knowledge and innovation, has shared its views on the European Union's Compulsory Licensing Framework Proposal. The organization commends the proposal and advocates for prioritizing public interest over commercial interests in compulsory licensing.
IDEMIA very much welcomes this proposal of regulation, which provides for harmonized rules for the compulsory licensing of patents in case of crisis. IDEMIA believes it will ensure a better resilience of the EU and the single market in case of crisis by ensuring swift and efficient mitigation measures are put in place. However, IDEMIA has some concerns about this proposal it would like to share.
BEUC welcomes the European Commission's proposal for a regulation on compulsory licensing for crisis management. Such a framework is necessary to enable a swift and appropriate response to a crisis or emergency by guaranteeing the supply and the free movement of crisis-critical patented products in the Single Market. However, the Commissions proposal calls for certain improvements: 1.
IP Europe is a coalition of R&D-intensive organisations whose inventions are protected by Intellectual Property Rights. IP Europes goal is to promote the vital importance of IPR in general, and standard essential patents (SEPs) in particular, to the digital-and knowledge-based economy and to ensure that public policies support a strong open innovation ecosystem.
In principle, a lean, uniform, efficient system in the internal market is welcomed instead of a patchwork of 27 different procedures across Member States. If supply chains cannot offer the provision of necessary services and goods in case of crisis, regulatory instruments that can ensure this functioning are supported.
This proposal is extremely worrying, especially as patents enabled the pharmaceutical industry to react quickly to COVID-19 and laid the foundations for the cooperation and partnerships needed to defeat the virus and end the pandemic. Much of this work was based on products, knowledge and research capacities developed over many years, supporting a strong and stable IP system.
Filed in Danish · English published by the European Commission
BIO is deeply concerned with the Commissions initiative to revise its compulsory licensing (CL) legislation. The proposal of a revised CL regime suggests that the envisioned new framework remedies a dysfunctional system despite no objective evidence that the existing regime is inadequate.
The European Commission proposal COM(2023)224 and accompanying documents is an overdue step forward towards a more nuanced balanced between innovation and access as it aims to streamline and facilitate the use of Compulsory Licenses.
On behalf of the Japan Pharmaceutical Manufacturers Association (JPMA) Intellectual Property Committee, we hereby provide our public comments on the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on compulsory licensing for crisis management and amending Regulation (EC) 816/2006-COM(2023)224 (Proposed Regulation).
During the COVID-19 pandemic, voluntary partnerships and cooperation, including licensing, enabled the rapid production and production of vaccines. Furthermore, it was thanks to basic research and a well-functioning intellectual property system that effective vaccines could be researched, developed and then produced at record speed.
Filed in Swedish · English published by the European Commission
In its Compulsory Licensing (CL) proposal, the European Commission (EC) posits a new EU-wide CL for crisis response. This harms IP rights and is a dramatic expansion of the ECs role into Member State (MS) remit, where viable CL provisions already exist. CLs are a last resort, all attempts at voluntary licensing having failed.
Medicines for Europe welcomes the opportunity to provide valuable feedback on the EC proposal to review the compulsory licensing system in Europe. At Medicines for Europe, we firmly maintain that voluntary licensing agreements present the most effective approach to tackle health crises.
The development of new medicines requires extensive research and considerable time and resources, the path from basic research to a new authorised medicine is long and involves many uncertainties. To deal with uncertainties, and the long timelines for development and marketing authorisation, IP rights are fundamental.
Pfizer welcomes the opportunity to respond to the proposal. Our purpose Breakthroughs that change patients lives fuels everything we do and reflects our passion for science and our commitment to patients. Alongside this, a strong system of intellectual property (IP) protection provides the economic incentive necessary to achieve sustainable scientific advancement and enable companies like Pfizer to apply their…
MEDEF comments on the European Commission proposals dated 27 April 2023 for a Regulation on the unconditional supplementary protection certificate for plant protection products; on compulsory licensing for crisis management and amending Regulation (EC) 816/2006; on standard essential patents and amending Regulation (EU) 2017/1001 (Patent package).
Filed in French · English published by the European Commission
The COVID-19 pandemic has shown the importance for Europe to have the right tools to respond to major health crises. The EU has already adopted several laws to improve its ability to respond to health emergencies and the coordination between the Member States.
The EC proposal on the granting of compulsory licences (LO) is of great concern to FARMAINDUSTRIA by providing for the suspension of IP rights and preventing the choice of partners to voluntarily grant manufacturing licences for their products without any legal basis being observed to limit the use of this measure.
Filed in Spanish · English published by the European Commission
The U.S. Chamber of Commerce welcomes the opportunity to share our perspectives on the European Commissions revised framework for compulsory licensing (CL) of patents. Both the U.S. and EU economies lead the world in intellectual property (IP) protection, as evidenced by the Chambers International IP index.
The IP Federation represents IP intensive companies in the United Kingdom - a list of members is at: https://www.ipfederation.com/member-list/ The IP Federation supports the BusinessEurope position paper on compulsory licencing for crisis management submitted on 19 July 2023 and also available here: https://www.businesseurope.eu/publications/compulsory-licencing-crisis-management-businesseurope-position-paper
A predictable and reliable intellectual property system is necessary for companies to innovate. The existing systems of national compulsory licensing already create an appropriate IP environment, and an EU-wide Compulsory License would create unnecessary burdens for businesses.
Intellectual property protection is the key to promoting innovation and driving investment towards innovative production. The current IP protection system, as demonstrated by the COVID crisis, has played a crucial role in the path that innovative pharmaceutical companies, governments and research partners have successfully carried out in order to quickly respond to unmet medical needs.
Filed in Italian · English published by the European Commission
BUSINESSEUROPE is the leading advocate for growth and competitiveness at the European level, standing up for companies across the continent and actively campaigning on the issues that most influence their performance. We speak for enterprises of all sizes in 35 European countries whose national business federations are our direct members. Patents are meant to stimulate innovation.
Confindustria contributed and agrees with BusinessEurope's position paper on European Commission proposal for mandatory authorization for the crisis management. Confindustria, in line with European industry, expresses strong concern about the EC proposal, which risks weakening the European patent law system to the detriment of innovation and competitiveness in the Eurozone
Forum of International Research and Development Pharmaceutical Companies, EIG (FarmaForum), as a Slovenian innovative pharma industry association, expresses its concern regarding the European Commission's (EC) proposal of the new compulsory licensing legislation. The EC's proposal introduces a new right to issue compulsory licenses throughout the EU, which the EC would activate in a "crisis" situation.
Innovation is the lifeblood of the biopharmaceutical industry and has delivered some of the most incredible life-changing innovations for safeguarding and improving health. Policy and legal frameworks must therefore continue to incentivise and create environments that drive innovation for long-term wellbeing and economic growth, as well as providing solid platforms for response to new and emerging health threats.
The current very robust intellectual property protection system (SGE) in the EU has made it possible to invest significantly in research to develop novel AM (AM) and vaccines, including those to fight COVID-19. The SGE has put in place the legal framework and incentives to do so. This formed the basis for countless cooperation that was and is necessary for the entry into the trade mark.
Filed in German · English published by the European Commission
Compulsory Licensing in the EU: Call for Evidence Submission by Access to Medicines Ireland (AMI) 29 April 2022 [max 4000 characters] AMI is a voluntary membership group of Cómhlamh, and we welcome the opportunity to provide feedback on the EU’s proposal to review the compulsory licensing in Europe.
Without the robust IP system, significant investments in R & D in novel technologies, vaccines, therapeutic & other products, including COVID-19, would not have taken place over the last decades. IP is a key tool to promote innovation and secure high-risk and high-cost investments for this purpose.
Filed in German · English published by the European Commission
Médecins Sans Frontières/Doctors Without Borders (MSF) welcomes the European Commission (EC)’s ambition to improve compulsory licensing (CL) in the EU. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the Doha Declaration recognise that WTO members are free to determine the grounds on which to issue a CL.
International Treatment Preparedness Coalition (ITPC) & Médecins du Monde (MDM) Compulsory licensing (CL) is one of the few existing tools to balance general interest and private rights. To enhance the efficiency of this legal mechanism in the EU, especially in public health, several actions are needed: Public interest and health grounds The TRIPS agreement allows WTO Member States (MS) to set the grounds for…
Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries (53% of our APIs are manufactured in house, 40% of which are in Europe), and in 2020 saving healthcare systems more than 8.4. billion EUR across 9 European countries in which we support more than 105,000 jobs.
The Confederation of Swedish Enterprise is Sweden’s largest and most influential business federation representing 60 000 member companies. Among the member companies many are Small and Medium-Sized Enterprises (SMEs). The Confederation of Swedish Enterprise (Svenskt Näringsliv) is taking an active part in the field of intellectual property rights since knowledge-based assets are crucial in the knowledge economy.
1. Compulsory licences are an important public health safeguard ensuring access to medicines, vaccines, diagnostics and health technologies in general at critical times that can be produced for different reasons. However, there are a number of legal obstacles that hinder the use of this mechanism effectively and quickly during a public health emergency, including within the EU. 2.
Filed in Spanish · English published by the European Commission
The European Alliance for Responsible R&D and Affordable Medicines welcomes the opportunity to provide feedback within this call for evidence in preparation of an impact assessment of compulsory licensing in the EU.
Health Action International (HAI) welcomes the step taken by the European Commission towards an enhanced use of Compulsory Licenses (CL) in EU territory; such measure will have a positive impact on access to medicines and health technologies, strengthening the ability of governments to fulfill the human right to health beyond crisis or exceptional circumstances.
The significant investment in research and development (R & D) by several actors and for many years in new technologies, vaccines, therapeutic and other products, now available to deal with COVID-19, would not have existed without the current and robust EU IP system.
Filed in Swedish · English published by the European Commission
AIM is the international umbrella organisation of federations of health mutuals and other not-for-profit healthcare payers. Its 54 members from 28 countries in Europe, Latin America and Africa and the Middle East provide compulsory and/or supplementary health coverage to around 240 million people around the world, including close to 200 million people in Europe, on a not-for-profit basis.
The CNCPI, a body set up by the French Intellectual Property Code and representing the regulated liberal profession of all French patent agents, thanked the European Commission for the opportunity to participate in this call for contributions and welcomed its willingness to consult with a view to possible legislative work on compulsory patent licences.
Filed in French · English published by the European Commission
IP EUROPE RESPONSE EC Call for Evidence for an Impact Assessment on the Revised Framework for Compulsory Licensing of Patents About IP Europe IP Europe is a coalition of research and development-intensive organisations whose inventions are protected by intellectual property rights.
1. In the European Union (EU)’s revised framework for compulsory licensing of patents, the EU anticipates establishing an EU-level compulsory licence for use in a crisis, acknowledging that a patchwork of fragmented, national compulsory licensing laws are not fit for purpose in dealing with the pandemic response or other crises. The following are KEI Europe’s recommendations regarding this issue. 2.
Intellectual property (IP) protections provide a vital framework to help enable the continuous investment in cutting-edge research and development of innovative and life-changing treatments and cures, including in times of a health crisis. IP encourages the disclosure of information and data that promotes competition, as well as collaboration and knowledge-sharing.
AIM is the international umbrella organisation of federations of health mutuals and other not-for-profit healthcare payers. Its 54 members from 28 countries in Europe, Latin America and Africa and the Middle East provide compulsory and/or supplementary health coverage to around 240 million people around the world, including close to 200 million people in Europe, on a not-for-profit basis.
ADIPA (the Association of Danish Intellectual Property Attorneys) generally agrees with the expected advantages that could be derived from an EU compulsory licensing system and supports the commission’s initiative and suggestions. ADIPA’s support is made with the reservation that the current suggestions are not very concrete.
Without the continuous and substantial investments in R &D, new technologies would not be developed. The (mRNA) vaccines and medicines used in the COVID pandemic would not have been there without the robust EU Intellectual Property (IE) system. IE, more specifically patents provide incentives for innovation through knowledge-sharing and in return temporary market protection to recoup (financial) investments.
Filed in Dutch · English published by the European Commission
The position of the Stanislas de Boufflers Institute regarding compulsory licensing has been made public in May 2021 (https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3850550). Briefly, the Institute considers that voluntary agreements between patent holders and those willing to produce vaccines should be favoured and promoted in the first place.
Bio Germany is the German Association of Biotechnology Industries and, with 360 member companies, the voice of innovative SMEs in this sector. As the main objective of the COVID-19 pandemic, BIO Germany sees access to vaccines for everyone.
Filed in German · English published by the European Commission
A robust intellectual property framework is the essential key to promote innovation and to drive investments towards innovative manufacturing. The COVID19 crisis demonstrates that the current IP system has successfully played a crucial role in enabling innovation and collaboration, between biopharmaceutical innovators, Governments and research partners to speed up unmet medical needs, including hundreds of potential…
The BPI e.V. (BPI), representing more than 270 companies, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Start-ups. These companies ensure timely and safe drug supply for all patients across the EU and globally.
Finland’s reply to the European Commission’s Call for Evidence on the revision of the framework for compulsory licensing of patents Finland thanks the European Commission for its position on the initiative to review the functioning of the compulsory licensing framework for patents. Finland considers it important to strengthen the EU’s crisis preparedness and resilience.
Filed in Finnish · English published by the European Commission
Please find enclosed the opinion of the German Lawyers’ Association (DAV) by the Intellectual Property Committee on the Commission’s impact assessment on compulsory licensing in the EU. The DAV welcomed in principle an evaluation of the compulsory licensing system for patents. However, the DAV is critical of the creation of a uniform system of compulsory licensing in the EU.
Filed in German · English published by the European Commission
Strong IP protection has allowed the pharmaceutical industry to react quickly to COVID-19 and facilitates the cooperation and partnerships needed to defeat the virus and end the pandemic. Much of this work builds on products, knowledge and research capacities developed over many years to support a strong and stable IP system.
Filed in Danish · English published by the European Commission
In previous years, many innovative vaccines, new technologies and products were developed that are now ready to use against the COVID-19 pandemic and in many more treatment fields. This innovation would not be possible without investment in R&D by many subjects throughout many years. However, the willingness of these subjects is dependent on the existence of a comprehensive intellectual property system in the EU.
The substantial investment in R&D by multiple actors over many years into novel technologies, vaccine, therapeutic and other products now available to address Covid-19 would not have occurred without the robust IP system in the EU and elsewhere. IP, particularly patents, has provided the legal framework and incentive for the high risk, high-cost investment underpinning the response to the pandemic.
In this contribution, DIGITALEUROPE follows up on the IP Action Plan’s proposal to evaluate the EU’s Compulsory Licensing framework. This builds on the comments previously provided as part of our comments on the IP Action Plan as a whole (our 2021 paper is attached separately).
PhRMA, and the innovative biopharmaceutical companies that it represents, has serious concerns with the call for legislative action regarding compulsory licensing in the EU and its Member States. While the call for evidence recognizes that compulsory licensing should be a tool of last resort, it suggests that there is a need for a central compulsory licensing mechanism in Europe for use in a potential crisis.
Attached please find the comments of the Intellectual Property Owners Association regarding the European Commission’s call for evidence regarding a potentially revised framework for compulsory licensing of patents. Thank you for this opportunity to comment.
The substantial investment in R&D by multiple actors over many years into novel technologies, vaccine, therapeutic and other products now available to address Covid-19 would not have occurred without the robust IP system in the EU and elsewhere. IP protections, particularly patents, has provided the legal framework and incentive for the high risk, high-cost investment underpinning the response to the pandemic.
FIR ( the Danish Group under the International Association for the Protection of Intellectual Property(AIPPI)) generally agrees with the expected advantages that could be derived from an EU-wide compulsory licensing system and supports the commission’s initiative and suggestions. FIR’s support is made with the reservation that the current suggestions are not very concrete.
Compulsory licensing of patents in the European Union Submission by Medicines Law & Policy, 28 April 2022 Medicines Law & Policy (ML&P) welcomes the opportunity to respond to the call for evidence for an impact assessment of compulsory licensing in the EU.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the European trade association for small to mid-sized innovative companies active in the field of pharmaceuticals and medical technologies at the European level.
Medicines for Europe welcomes the chance to provide feedback on the proposal to review the compulsory licensing system in Europe. Medicines for Europe is strongly convinced that voluntary licensing agreements are the right way forward to tackle health crises.
In the BDPA’s view, the aim should be to adopt a directive to approximate the national laws of all EU Member States concerning the issuing of state use orders and the granting of compulsory licences for patents, as a timely possibility to be implemented. The following shall be taken into account: (a) Such measures must remain exceptional in absolute circumstances.
Filed in German · English published by the European Commission
The Bundesverband Deutscher Patentanwalt (BDPA) is an association representing the profession of German patent attorneys, in particular professional patent agents. The BDPA should be given an objective answer to questions and problems in the field of industrial property.
Filed in German · English published by the European Commission
Method. Every quote is verbatim from the organization’s own submission to the European Commission, trimmed to its opening passage and never summarized by a model. Where a submission was filed in another EU language we show the English text the European Commission publishes alongside it, labeled on the quote; the original is one click away at the source. Groupings use the respondent type the organization itself selected when filing. We deliberately do not label anyone “supportive” or “opposed” — you read what they wrote and draw your own conclusion. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.
