In November 2020, the European Commission proposed a new Pharmaceutical Strategy for Europe aimed at ensuring the quality and safety of medicines while strengthening the sector’s global competitiveness.
The most important objectives are:
To eliminate weaknesses, especially in the availability of medicines, that were revealed by the COVID pandemic;
To create a future-proof legal framework; and
To support the industry in driving forward R&D of technologies, especially in areas that benefit patients.
Further information on the European Commission’s proposal and the European pharmaceutical strategy can be found in Maiwald blog articles posted on March 8 2023 and January 4 2021, respectively.
Following an impact assessment and a public consultation in March 2021, the European Commission examined three options and, among other things, commissioned a study to support the evaluation, and create an impact assessment, of the EU’s general pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No. 726/2004).
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, as well as a 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.
On April 10 2024, the European Parliament approved the proposed regulation and directive, albeit with significant amendments.
The protection for medicinal products created by patents and supplementary protection certificates interacts with the protection for authorised medicinal products, which is granted by data protection and market protection. These are regulated separately from each other and, according to the current proposals, should remain separate from each other in the future.
The status quo
Anyone wishing to market a medicinal product subject to authorisation in Germany must first go through the authorisation 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) of the AMG.
There is a special regulation for generics manufacturers in the form of Section 24b of the 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.
The 8+2+1 rule
Currently, the so-called 8+2+1 rule applies in Germany pursuant to Section 24b of the AMG, which implements Article 10, paragraph 1 of Directive 2001/83/EC, according to which, there is protection against access to the marketing authorisation 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 (see Article 8(1) of Regulation (EC) No. 141/2000) in the context of so-called orphan drugs).
If a generics manufacturer decides to obtain marketing authorisation 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 authorisation for a new indication for the same medicinal product within the first eight years after the initial authorisation.
In total, a regulatory protection period of 10 to 11 years is awarded under the current system.
Proposed regulation
The new regulation proposed by the European Commission initially provided for a more complicated and more detailed provision on data protection and market protection, which was significantly revised by proposals by the European Parliament that are no less complicated (see P9_TA(2024)0220 and P9_TA(2024)0221).
The Commission had originally proposed a 6+2+0.5+0.5+1+2 system. According to articles 80 and 81 of the proposed directive, a so-called data protection period in the proposal of six years from the date of authorisation 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 to promote R&D activities.
Compared with the previous 8+2+1 rule, however, the proposed rule would have shortened the protection to eight years as opposed to the previous 10 years in favour of generics and biosimilar companies.
The European Parliament has now proposed an amendment in the form of a 7.5+1+0.5 (but a maximum of 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 that cover an unmet medical need and by six months if the marketing authorisation research was carried out within the EU and at least partially in cooperation with public institutions such as universities.
However, the data protection period should not exceed a total of 8.5 years, so it must be concluded that, contrary to the wording, the extension in the case of a second marketing authorisation is not for 12 months but for six or 12 months, depending on whether a six-month extension has already been granted.
With regard to market protection, the European 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 authorisation for a further indication with significant clinical benefit has been reinstated.
According to the European 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 with the 10 years previously possible.
Suspension of the protection
Unchanged by the European Parliament, Article 80(4) of the new proposal for a directive provides for the suspension of regulatory protection in the event that a compulsory licence 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 standardise what the European Commission considers to be a “patchwork of different national regulations” (see European Commission proposal COM/2023/224 final and European Parliament proposal P9_TA(2024)0143).
Final thoughts on the European Parliament’s proposal and next steps
What is interesting about the European 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 completely.
It remains to be seen whether the European 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.
