Supplementary protection certificate for plant protection products. Recast
63 submissions from 49 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 93 submissions on this file. Shown here: the 63 from organizations. Not shown, by design: submissions from private individuals, which we never publish, and anything filed since our last weekly refresh.
CommitteeJURIRapporteurTiemo Wölken (S&D)
Deliberations in Council working party · 6 Feb 2026
Deliberations in Council working party · 21 Jan 2026
Deliberations in Council · 8 Dec 2025
Deliberations in Council working party · 5 Dec 2025
Deliberations in Council working party · 17 Nov 2025
Who showed up
44 submissions from industry — companies and their trade associations — against 14 from civil society: NGOs, consumer organizations, environmental groups and trade unions. That is 3.1 industry submissions for every one from civil society.
Industry 44Civil society 14Public authorities, academia, other 5
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
21 of 49
in the EU Register
111
full-time lobbying staff
€28.2M+
declared costs a year
99
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 20 Sept 2023 — it ran from 27 Apr 2023.
PhRMA joins EFPIA in raising significant concerns with the European Commissions (ECs) proposal to establish a new mechanism for parties to oppose the grant of SPCs. While PhRMA supports the general intent of the proposed recast of the SPC Regulation to establish a centralized process for seeking SPCs in the EU without altering the substance of that protection, the proposed procedure includes redundant and…
On April 27, 2023, the European Commission submitted proposals for the reform of intellectual property rights for medicinal products. Among other things, a unitary European supplementary protection certificate is to be established to complement the unitary European patent already introduced by Regulations (EU) No. 1257/2012 and (EU) No. 1260/2012 and due to start in 2023.
On April 27, 2023, the European Commission submitted proposals for the reform of intellectual property rights for medicinal products. Among other things, a unitary European supplementary protection certificate is to be established to complement the unitary European patent already introduced by Regulations (EU) No. 1257/2012 and (EU) No. 1260/2012 and due to start in 2023.
Feedback on the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013 COM(2023)222
Please find enclosed the contribution of the National Company of Industrial Property Councils (CNCPI). The CNCPI is the French official body comprising all the Industrial Property Councils (CPI), i.e. liberal professionals practising in France and authorised to represent third parties before the Institut National de la Propriété Industrielle (INPI) in patent matters (including supplementary protection certificates)…
Filed in French · English published by the European Commission
Medicines for Europe is glad to be able to provide its feedback and emphasizes the need for safeguards to ensure high quality SPCs, prevent litigation strategies and ensure access to affordable medicines. First, SPC holders should be able to obtain a SPC protection so to enjoy an overall maximum of 14 years of exclusivity from the marketing authorisation.
The LIF is generally in favour of harmonising and streamlining the SPC application process, but Lif has identified several uncertainties and concerns that need to be addressed, see Annex. Essentially, the possibility of pre grant opposition procedure for a third party should be excluded from the proposal. Furthermore, procedural aspects and timelines should be clarified.
Filed in Swedish · English published by the European Commission
The LIF is generally in favour of harmonising and streamlining the SPC application process, but Lif has identified several uncertainties and concerns that need to be addressed, see Annex. Essentially, the possibility of pre grant opposition procedure for a third party should be excluded from the proposal. Furthermore, procedural aspects and timelines should be clarified.
Filed in Swedish · English published by the European Commission
Farmaindustria, as the representative of the innovative pharmaceutical industry established in Spain, welcomes the proposed revision of the SPC Regulation of, given its objective of creating a harmonised and centralised approach to the application, evaluation and granting of SPC for both classical European and unitary patents (UPs), providing a clearer and more efficient framework for industrial property in the EU…
Filed in Spanish · English published by the European Commission
EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection.
EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection.
The Chartered Institute of Patent Attorneys (CIPA) is the professional and examining body for patent attorneys (also known as patent agents) in the United Kingdom. The Institute was founded in 1882 and was incorporated by Royal Charter in 1891. It represents virtually all of the 2,645 registered patent attorneys in the United Kingdom, whether they practice in industry or private practice.
The Chartered Institute of Patent Attorneys (CIPA) is the professional and examining body for patent attorneys (also known as patent agents) in the United Kingdom. The Institute was founded in 1882 and was incorporated by Royal Charter in 1891. It represents virtually all of the 2,645 registered patent attorneys in the United Kingdom, whether they practice in industry or private practice.
The Chartered Institute of Patent Attorneys (CIPA) is the professional and examining body for patent attorneys (also known as patent agents) in the United Kingdom. The Institute was founded in 1882 and was incorporated by Royal Charter in 1891. It represents virtually all of the 2,645 registered patent attorneys in the United Kingdom, whether they practice in industry or private practice.
The Chartered Institute of Patent Attorneys (CIPA) is the professional and examining body for patent attorneys (also known as patent agents) in the United Kingdom. The Institute was founded in 1882 and was incorporated by Royal Charter in 1891. It represents virtually all of the 2,645 registered patent attorneys in the United Kingdom, whether they practice in industry or private practice.
Supplementary protection certificates, by restoring part of the effective duration of patent exclusivity and applying in the presence of the MA, are crucial to ensure sustainable investment in research and development of new medicines and vaccines. Farmindustria supports the creation of a unitary SPC.
Filed in Italian · English published by the European Commission
The creation of a supplementary unitary protection certificate (SPC) will incentivise plant protection companies to participate in the unitary patent system. In the absence of a robust unitary certification system, there would be uncertainty and inconsistency in the European Union as regards the implementation and validity of unit certificates.
Filed in Spanish · English published by the European Commission
CropLife Europe is pleased to share its views on the proposal on the unitary Supplementary Protection Certificates (SPC) for Plant Protection Products (PPPs). Its key messages include: (i) The system to grant a unitary SPC for PPPs needs to align with the current procedures for PPP marketing authorisations; (ii) Pre-grant opposition proceedings create unnecessary delays; (iii) The unitary SPC should be adopted as…
Please find enclosed a feedback from the Bundesverband Deutscher Patentanwalt e.V. on the Commission’s proposal for a uniform procedure for the granting of supplementary protection certificates. Yours sincerely, Detlef by AHSEN
Filed in German · English published by the European Commission
On behalf of Mr Stephan Freischem, Secretary-General of the German Association for Industrial Property and Copyright (GRUR), I enclose the GRUR’s opinion on the Commission’s SPC proposals. We also submitted our comments to the German Federal Ministry of Justice on 9 August 2023. Should you have any further questions, please do not hesitate to contact us.
Filed in German · English published by the European Commission
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.
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.
Forum of International Research and Development Pharmaceutical Companies, EIG (FarmaForum), as a Slovenian innovative pharma industry association, generally supports and accepts the objectives outlined by the European Commission regarding proposed changes to the EU framework for SPCs for medicinal products.
The German Environment Agency (UBA) welcomes the possibility to provide its views on a regulation on supplementary protection certificates (SPCs). Residues of pharmaceuticals, be it the active ingredient itself or their metabolites, are practically ubiquitous in the environment, as they are excreted by patients after intended use and wastewater treatment plants are often hardly able to eliminate these trace…
The supply of innovative products such as pharmaceuticals and plant protection products is a complex, time-consuming and financially risky process. The patent system guarantees investment protection in return for the provision of the knowledge acquired.
Filed in German · English published by the European Commission
Dear Sirs, The Standing Committees Unitary Patent/Unified Patent Court as well as teh Standing Committee Pharma of the AIPPI have concluded the attached declaration with respect to Unitary Patents and SPCs. The International Association for the Protection of Intellectual Property, known as AIPPI (Association Internationale pour la Protection de la Propriété Intellectuelle), is the world’s leading non-profit…
INTERPAT is a global trade association of Chief intellectual property (IP) Counsels from the biopharmaceutical industry that seeks to share knowledge, experience and expertise in creating and nurturing sustainable innovation ecosystems in life sciences.
1. A Unitary Supplementary Protection Certificate, providing a uniform scope in the same territory as the Unitary Patent which serves as its basic patent, should be made available under the enhanced cooperation between EU member states. 2. As the basic patent of a Unitary SPC, only European patents with unitary effect (Unitary Patents) should be eligible. 3.
The supply of innovative products such as medicines is a complex, time-consuming and financially risky process. The patent system guarantees investment protection in return for the provision of the knowledge acquired.
Filed in German · English published by the European Commission
Pharmaceutical companies turn scientific insights into medicinal treatments by conducting lengthy R&D that establish the therapeutic properties of compounds for humans and animals. This “knowledge” is extremely difficult and expensive to produce, requiring over a decade of tests and clinical trials with a 90% failure rate in last phases. It is thanks to robust IP protection that we have medicines.
The European Social Insurance Platform (ESIP), representing statutory social health insurances in the EU and Switzerland, welcomes the intention to revise and rebalance incentives in the pharmaceutical sector, including supplementary protection certificates (SPCs). Any regulatory revision should aim at promoting fair competition and access to affordable medicines.
Médecins Sans Frontières (MSF) recently published research in a peer-reviewed journal (attached) on supplementary protection certificates and their impact on access to medicines in Europe.1 The study examines sales revenue of and R&D investments in a number of lifesaving medicines (sofosbuvir, trastuzumab, and imatinib).
FICPI Sweden provides the following suggestions in response to the European Commission’s Call for evidence for an impact assessment on medical and plant protection products – single procedure for the granting of SPCs. 1.
Bayer is committed to continuously working with the EU Institutions, Member States and all other stakeholders towards creating a healthier future, improved food systems and a more competitive Europe. Therefore, we welcome the opportunity to share feedback in the call for evidence of the European Commission’s impact assessment regarding a unitary SPC and/or single SPC granting mechanism.
Bringing new therapies to patients is a long, complex and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions.
The Pharmaceutical Research and Manufacturers of America, and the innovative biopharmaceuticals companies that they represent, commend the European Commission’s call for the development of a single procedure for the granting of supplementary protection certificates (SPCs) in Europe.
The SPC is a very important intellectual property right for pharmaceutical companies, enabling innovation and the making available of new medicines. The positive effect of the SPC in this regard was confirmed by the Commission’s evaluation of the SPC legislation in 2020. In view of the above, Lif strongly believes that no changes should be made to the SPC itself or to related legislation (alt C2).
Filed in Swedish · English published by the European Commission
The Association of Danish Intellectual Property Attorneys (ADIPA) support a Unitary Supplementary Protection Certificate, providing a uniform scope in the same territory as the Unitary Patent which serves as its basic patent, should be made available under the enhanced cooperation between EU member states.
The Danish Group under the International Association for the Protection of Intellectual Property (AIPPI) welcomes the initiative from the European Commission proposing legislative amendments to the current SPC system.
Dear Sirs, thank you for the involvement into the strategical discussion on the Supplementary Protection Certificates (SPCs). Indeed, the competitiveness of the European active pharmaceutical ingredient producers (and accordingly the robustness of European-based generics industries) with respect to foreign competitors is a crucial aspect to be evaluated and supported.
APOGEN welcomes the chance to provide feedback on the proposal to reduce fragmentation in the SPC system. The Call for Evidence (CfE) makes almost no reference to a need to tackle fragmentation in enforcement/litigation phase of SPC lifecycles, arguably the highest priority for ensuring timely patient access to generic/biosimilar medicines, legal certainty & address national budget issues, ignoring the core problem…
The CNCPI, a body representing the regulated liberal profession comprising all French patent agents, thanks the European Commission for the opportunity to participate in this call for contributions and welcomes its desire to review the system for granting supplementary protection certificates (SPCs).
Filed in French · English published by the European Commission
Bringing new therapies to patients is a long, complex and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions.
Family-owned since it was established in 1885, Boehringer Ingelheim pursues a long-term vision and stands for continuous investment in medical innovation to improve the health and quality of life of humans and animals. We welcome the opportunity to input into this consultation and urge the EU Commission (EC) to consider the below industry view put forward by EFPIA.
The Deutscher Anwaltverein (DAV) is the professional association for lawyers in Germany; membership is optional. The DAV brings together more than 61 000 lawyers and notaries of lawyers, organised in 252 local lawyers’ clubs at home and abroad. He represents the interests of the German Bar at national, European and international level. This opinion responds to the Commission’s request of 8.3.2022.
Filed in German · English published by the European Commission
The VCI expressed its gratitude for the possibility of issuing an opinion on an impact assessment on: “Medicinal products and plant protection products — uniform procedure for the granting of supplementary protection certificates” of 8 March 2022 and comments in the attached document.
Filed in German · English published by the European Commission
The development and marketing of new medicines requires time and investment in research, the outcome of which is uncertain: many developments do not lead to a useful medicine. There is no doubt that a well-functioning IP system is indispensable for a good innovation and investment environment.
Filed in Dutch · English published by the European Commission
Pro Generika is the German Association of the Generics and Biosimilar Pharmaceutical Industry. It has 17 members covering around 70 % of the German generics market. Our member companies guarantee for the German health system that every patient has access to modern and affordable medicinal therapies.
The planned examination by the Commission is a further step in the discussions that have been going on for years in the sensitive area of supplementary protection certificates, which is extremely important for the pharmaceutical industry. An evaluation of options is therefore to be welcomed.
The Human Body is made up of the same ingredients as Plants as well as Mother Earth/Planet. For a healthy Body we need to comply to the Natural Law of the Human Body which is part of Human Rights. We all know consumption of raw salad vegetables etc. are Healthy. We give our teething child a stick of carrot, cucumber etc for them to gnaw at which also sooths their gums.
Gedeon Richter welcomes the chance to provide feedback on the proposal to reduce fragmentation in the SPC system. The Call offers several policy options to achieve specific policy objectives such as to increase legal certainty about the procedure for granting SPCs, to provide unitary SPC protection in relation to unitary patents.
GSK supports policy initiatives that aim to modernise the existing EU IP framework to ensure it remains robust, agile and predictable for investments in research. A healthy innovation ecosystem is the foundation for both a strong, vibrant and globally competitive industry in Europe as well as a healthcare system that benefits patients and society.
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.
Research and development of new innovative medicines is a very costly and lengthy process, thus also entailing significant commercial risks for businesses. Patents are therefore a prerequisite for a successful pharmaceutical industry that creates value and welfare for patients.
Filed in Danish · English published by the European Commission
Bringing new therapies to patients is a long, complex, and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions.
Medicines for Europe welcomes the chance to provide feedback on the proposal to reduce fragmentation in the SPC system. The Call for Evidence (CfE) makes almost no reference to a need to tackle fragmentation in enforcement/litigation phase of SPC lifecycles, arguably the highest priority for ensuring timely patient access to generic/biosimilar medicines, legal certainty & address national budget issues, ignoring the…
The European Commission is examining measures to optimise the existing system of Supplementary Protection Certificates (SPCs) in order to make it more transparent and efficient. SPCs are an intellectual property protection instrument that has the effect of extending the term of protection of a pharmaceutical patent by up to five years.
Filed in German · English published by the European Commission
Research and development of new innovative medicines is a very costly and lengthy process, patents are therefore a prerequisite for a successful pharmaceutical industry that creates value and welfare for patients. SPCs, ensure sustainable financing of innovation by precisely compensating for the period of patent exclusivity lost during a lengthy and costly research and development process.
Filed in Danish · English published by the European Commission
Dear Sir/Madam, Supplementary Protection Certificates are an integral part of the process for protecting innovation in plant protection products. We therefore greatly appreciate the opportunity to participate in the call for evidence on a unitary SPC and/or single procedure for granting national SPCs. Please find attached CropLife Europe's feedback to this call for evidence.
A centralized system for the grant and enforcement of a Unitary SPC (“uSPC”) through a single procedure, analogously with what is being achieved with the European Patent with Unitary Effect and Unified Patent Court ( EP-UE and UPC, respectively) is certainly a very desirable option with a view to creating a more predictable, less burdensome and cost-effective system for Europe.
Medicines for Poland has a negative opinion on the plans to implement the Unitary Supplementary Protection Certificate (SPC) system. The same view is also shared by Medicines for Europe. In the discussion on the possible introduction of a single SPC, the following issues should not be overlooked: • A unitary SPC system would actually increase the geographic scope of protection: Currently, SPCs are not registered in…
Bringing new therapies to patients is a long, complex and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions.
Making new therapies available to patients is a long, complex and risky process that requires considerable investment, giving industrial protection — and the period for which it is effective — a key role in embarking on this process.
Filed in Spanish · 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.
