iStockphoto/enviromantic

Amendment to the pharmaceutcal legislation – insights into a complex proposal

Working drafts provide first insights

CC – 02/2023

With the proposal on the amendment to the pharmaceutical legislation, which is to be presented on 29 March, the European Commission aims to secure or improve access, availability and affordability of pharmaceutial products. According to the European Commission, the aim is to create a balanced and competitive system that keeps pharmaceutial products affordable for healthcare systems while promoting innovation.

Draft versions of the amendment pharmaceutical legislation

About two months prior to the official publication, working drafts and accompanying documents have been made public. They have not been officially published by the European Commission as internal consultations are still ongoing. Therefore, the contents are still subject to change until the official release. Nevertheless, one gets a first glimpse of the project.

Two new laws on medicinal products - one regulation and one directive

The amendment is intended to pass two new laws on pharmaceutical products. On the one hand, the directive establishing a Union code on medicinal products for human use is being entirely redrafted. Secondly, the five existing regulations - laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency, as well as on advanced therapies, clinical trials, medicinal products for paediatric use, orphan drugs - are to be merged into one legislative text.

Shortening market exclusivity

According to the initial considerations of the European Commission, the market exclusivity of pharmaceutical products is to be shortened, or at least made subject to conditions in specific cases. When medicines are launched in all 27 EU Member States, meet unmet medical needs (UMN) or undergo rigorous clinical trials with comparator therapies, there are additional periods of market exclusivity. The term of patent on orphan drugs - i.e. pharmaceutical products for rare diseases - is also to be shortened to 9 years, unless specific conditions are met.

Delivery bottlenecks

In order to avoid shortages in pharmaceuticals, their manufacturers are to draw up a "shortage prevention plan". In the event of an imminent interruption of supply, they should inform the EU Member States as soon as possible, but at least six months in advance. In addition, there is to be a list of medicinal products that are critical for the supply. Reporting and information obligations of Member States and manufacturers are to be linked to the listed pharmaceutical products in order to make bottlenecks transparent and allow countermeasures to be taken. In addition, as a lesson learned from the COVID-19 pandemic, the European Commission is planning a regulation to suspend patent protection in the event of a public health emergency.

Antimicrobial resistance

In order to provide incentives in the production of antibiotics, the European Commission plans to introduce transferable exclusivity vouchers (also called vouchers or TEE - Transferable Exclusivity Extension). The voucher is intended to extend the term of patent on a pharmaceutical product by one year and the developer of the new antibiotic can apply it once to a pharmaceutical product of its choice that has a central marketing authorisation. It should also be possible to sell the voucher to another pharmaceutical company.

In addition to these measures, the European Commission is planning, among other things, new regulations in the areas of package inserts, packaging, research transparency, reorganisation of the European Medicines Agency (EMA). The German Social Insurance (DSV) had already positioned itself in its feedback on the amendment to the legislation on medicinal products and the pharmaceutical strategy. The official proposal of the European Commission is now eagerly awaited at the end of March.