Back in November 2020, the European Commission proposed a new Pharmaceutical Strategy for Europe which aims at ensuring the quality and safety of medicines while strengthening the sector’s global competitiveness.
Specific objectives are, to eliminate weaknesses, especially in the availability of medicines, which have been revealed by the COVID-19 pandemic, as well as to create a future-proof legal framework and to support the industry in driving forward research and development of technologies, especially in areas which benefit patients. [1]
Following an impact assessment and a public consultation in March 2021, the EU Commission examined three different options and, among other things, commissioned a study to support the evaluation and impact assessment of the EU’s general pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No. 726/2004).[2]
The proposal for a reform package finally adopted by the European Commission on April 26, 2023 includes a new version of the Directive on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC [3] as well as the Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006[4] .
On April 10, 2024, the EU Parliament approved the proposed Regulation and Directive, albeit with some significant amendments.
The protection for medicinal products created by patents and supplementary protection certificates interacts with the protection for authorized medicinal products, which is granted by data protection and market protection.[5] These are regulated separately from each other and, according to the current proposals, should remain separate from each other in the future.
This first article in the three-part series deals with the proposed amendments to data protection and market protection.
Status quo
Anyone wishing to market a medicinal product subject to authorization in Germany must first go through the authorization procedure in accordance with Sections 21 et seq. of the German Medicinal Products Act (AMG) which, among other things, sets forth that clinical trials on the efficacy of the medicinal product must be carried out and the corresponding research results submitted to the competent authority in accordance with Section 22 (2) AMG. There is a special regulation for generics manufacturers in the form of Section 24b AMG, according to which, if they wish to market a generic product (based on a reference medicinal product), they may refer to the approval documents of a reference medicinal product without having to carry out extensive clinical trials and studies themselves.
8+2+1 rule
Currently, the so-called 8+2+1 rule applies in Germany pursuant to Section 24b AMG, which implements Art. 10 Para. 1 of Directive 2001/83/EC, according to which there is protection against access to the marketing authorization documents by third parties for a period of eight years after the approval of a medicinal product, the so-called data protection (also known as market exclusivity[6] in the context of so-called “orphan drugs”). If a generics manufacturer decides to obtain marketing authorization with reference to these documents, it may not place the medicinal product on the market for a further two years. During this period, the so-called market protection applies. These two years can be extended by a further year if the manufacturer of the reference medicinal product has obtained a further marketing authorization for a new indication for the same medicinal product within the first eight years after the initial authorization. In total, a regulatory protection period of ten to eleven years is awarded under the current system.
Proposed new regulation
The new regulation proposed by the Commission initially provided for a more complicated and more detailed provision on data protection and market protection, which was significantly revised by the Parliament’s proposal[7] , which is no less complicated. In detail:
The Commission had originally proposed a 6+2+0.5+0.5+1+2 system. According to Art. 80, 81 of the proposed Directive, a so-called “data protection period” in the proposal of six years from the date of authorization should apply. Under certain conditions, it was supposed to be possible to extend this period by up to four additional years in various cases. This is the first time that an extension option has been provided not for the two-year market protection, but for the data protection. According to the Explanatory Memorandum, the Commission wanted to focus on protection for innovative medicinal products in order to promote research and development activities.[8] Compared to the previous 8+2+1 rule, however, the proposed new rule would have shortened the protection to 8 years as opposed to the previous 10 years in favor of generics and biosimilar companies.
Parliament has now proposed an amendment in the form of a 7.5 + 1 + 0.5 (but max. 8.5) + 2 + 1 system.
The extension of the data protection of generally 7.5 years is now to be extended by one year for medicinal products which cover an unmet medical need and by six months if the marketing authorization research was carried out within the EU and at least partially in cooperation with public institutions such as universities. However, data protection period should not exceed a total of eight and a half years, so it must be concluded that, contrary to the wording, the extension in the case of a second marketing authorization is not for 12 months, but for 6 or 12 months, depending on whether a 6-month extension has already been granted or not.
With regard to market protection, the Parliament’s proposal is to maintain the two-year period. The extension privilege of a further year in the event that a medicinal product receives a new marketing authorization for a further indication with significant clinical benefit has been reinstated.
According to Parliament’s proposal, the regulatory protection period could therefore be extended to a maximum of 11.5 years, whereby the standard case would be a reduction in protection to 9.5 years compared to the 10 years previously possible.
Suspension of the protection
Unchanged by Parliament, Art. 80 (4) of the new proposal for a directive provides for the suspension of regulatory protection in the event that a compulsory license has been issued to deal with a public health crisis. A separate proposal for a regulation was introduced to create corresponding compulsory licences under EU law in times of crisis, which aims in particular to standardize what the Commission considers to be a “patchwork of different national regulations”.[9]
Further procedure
What is interesting about Parliament’s proposal is not only the change in the respective timelines, but above all the change in the reasons for the extensions. For example, the option for extensions for small research companies has been abandoned in completely.
It remains to be seen whether Parliament’s proposal will survive in its current form. So far, the proposal has only “survived” the first reading in Parliament and must now prove itself in further legislative procedure.
[1] On the Commission’s proposal and the European pharmaceutical strategy, we refer to previous blog posts (January 4, 2021 and March 8, 2023) as well as Stief/Grabow: Quo vadis pharmaceutical law – an overview of the revision of EU pharmaceutical legislation, PharmR 2023, 317 ff.
[2] European Commission, Directorate-General for Health and Food Safety, Jongh, T., Becker, D., Boulestreau, M. et al. (2021) Future-proofing pharmaceutical legislation – Study on medicine shortages: final report (revised). Publications Office of the European Union. https://data.europa.eu/doi/10.2875/211485
[3] Commission amendment proposal: COM/2023/192 final, available at https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:52023PC0192.
[4] Commission amendment proposal. COM/2023/193 final, available at https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:52023PC0193.
[5] Stief/Grabow: Quo vadis pharmaceutical law – an overview of the revision of EU pharmaceutical legislation, PharmR 2023, 317.
[6] Article 8(1) of Regulation (EC) No 141/2000.
[7] https://www.europarl.europa.eu/doceo/document/TA-9-2024-0220_EN.pdf and https://www.europarl.europa.eu/doceo/document/TA-9-2024-0221_EN.pdf.
[8] Explanatory Memorandum (COM(90) 101 final – SYN255), p. 16: Document protection for innovative medicinal products for up to 12 years; the transitional period should be mentioned – the new regulations should not apply to reference medicinal products for which applications for marketing authorization were submitted before 18 months after the Directive came into force.
[9] Commission proposal COM/2023/224 final, available at https://eur-lex.europa.eu/resource.html?uri=cellar:a58d3568-e4e2-11ed-a05c-01aa75ed71a1.0017.02/DOC_1&format=PDF; Parliament proposal P9 TA(2024)0143, available at https://www.europarl.europa.eu/doceo/document/TA-9-2024-0143_DE.pdf.
