About this consultation
Summary of the replies to the public consultation SWD(2018)242
All citizens and organisations are welcome to contribute to this consultation. Contributions are particularly sought from:
- originators in the agrochemical and pharmaceutical sectors (large companies, universities, start-ups, small and medium-sized enterprises)
- the EU-based generic and biosimilar medicines and plant protection products industry, and active pharmaceutical ingredients (APIs) suppliers
- innovative sectors whose products require pre-market regulatory authorisation but are not eligible for an SPC
- national authorities
- consumer organisations, patient groups, research and academic institutions, and individual citizens
Objective of the consultation
The Single Market Strategy, adopted in October 2015, announced that the Commission will ‘consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations’.
In particular, the Strategy aimed to explore a recalibration of certain aspects of patent and supplementary protection certificate (SPC) protection, and announced that this recalibration could comprise the following 3 elements:
- the creation of a European SPC title
- an update of the scope of EU patent research exemptions
- the introduction of an SPC manufacturing waiver
SPCs are a unique intellectual property right that constitute an extension (of up to 5 years) to the term of a patent right (of 20 years). SPCs apply to innovative pharmaceutical and plant protection products that have been authorised by regulatory authorities. They aim to offset the loss of effective patent protection that occurs due to the compulsory and lengthy testing and clinical trials that products require prior to obtaining regulatory marketing approval. The relevant EU legislation is Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96 on SPCs covering pharmaceutical and plant protection products respectively.
The ‘Bolar’ patent exemption aims at speeding up the entry of generic medicines into the market by allowing early preparatory development on generics to obtain pre-market regulatory approval, even when the SPC of the reference medicine is still in force. The Bolar exemption is regulated at EU level for the pharmaceutical industry only. This is done through Article 13(6) of Directive 2001/82/EC and Article 10(6) of Directive 2001/83/EC. The scope of the EU Bolar exemption has been updated in some EU countries, to meet new pharmaceutical-related requirements among other things. With this consultation the Commission seeks the views of stakeholders on the SPC and patent research exemption of SPCs. Citizens and stakeholders are invited to provide feedback on their experience and knowledge, which the Commission will carefully analyse before deciding whether and to what extent it should take further action. Input from stakeholders will be used for evaluation of the above legislation and impact assessment of any potential modification of the SPC and patent exemption framework in the EU.
How to submit your response
Please submit your contribution via one of the following online questionnaires.
The questionnaires are available in English, French and German. However, responses may be submitted in any official EU language.
- Economic Analysis of Supplementary Protection Certificates in EuropeEconomic Analysis of Supplementary Protection Certificates in Europe
- Assessing the economic impacts of changing exemption provisions during patent and SPC protection in EuropeAssessing the economic impacts of changing exemption provisions during patent and SPC protection in Europe
- 25 years of SPC protection for medicinal products in Europe: Insights and challenges25 years of SPC protection for medicinal products in Europe: Insights and challenges
View the contributions
In the interest of transparency, organisations are invited to provide the public with relevant information about themselves by registering in the Transparency Register and subscribing to its Code of Conduct. If the organisation is not registered, the submission will be published separately from the registered organisations.
Results of the consultation and next steps
The Commission will assess and summarise the results in a report, which will be made publicly available on the website of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. The results of this consultation will provide valuable input for the Commission when preparing an evaluation of EU legislation on SPCs, and any future policy proposals on SPCs and patent exemptions, including the assessment of the impact of different policy options.
Protection of personal data
The contributions received and the identity of the contributor will be published on this website, unless the contributor objects to the publication of their personal data.
Please read the specific privacy statement for information on how your personal data and contribution will be dealt with.