European Commission publishes proposal for new EU pharmaceutical legislation

On 26 April 2023, the European Commission  published its long-awaited  proposal for new EU pharmaceutical legislation. The new legislative proposal is intended to revise the entire European pharmaceutical legislation. 

The aim is to create a uniform legal framework for the research, development and production of medicinal products at a European level. This should ensure that all European patients have the same opportunities to benefit from innovative therapies and medicines. All patients should therefore have equal access to effective and affordable medicines. In addition, the increasingly frequent supply bottlenecks of medicinal products are to be prevented as best as possible. 

Reduced administrative burden 

A central approach of the Commission within the framework of the revision of the pharmaceutical legislation is to optimise the European authorisation procedure for medicinal products as much as possible and thus reduce the overall administrative burden. The aim is to make the European pharmaceutical industry internationally competitive and to promote the development and production of innovative medicinal products in Europe. 

Up to now, the European authorisation procedure has been very time-consuming and costly, which affects smaller and medium-sized companies in particular.

In order to be able to grant European marketing authorisations more efficiently in the future, the structure of the European Medicines Agency (EMA), which is responsible for marketing authorisations, is to be improved. In future, instead of seven European committees, only the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) will be involved in the authorisation process. The Commission expects this to avoid duplication of work and to improve the efficiency of the entire procedure. 

Streamlined timeframes

In addition to this structural change, it is planned that the EMA's decision-making period will be shortened. While the average duration of the European authorisation process currently takes about 400 days, the EMA is now to decide on an authorisation in 180 days.

Moreover, the digital submission of applications for authorisation is planned to simplify the authorisation procedure and minimise the administrative burden. Electronic patient information is also intended to save costs.  

Another starting point of the European Commission is the extension of the period of validity of the central European marketing authorisations. The Commission plans to grant European marketing authorisations for medicinal products for an indefinite period of time in the future. Currently, marketing authorisation are usually granted for five years only. Which leads to the fact that after the expiry of these 5 years, a new examination of the medicinal product becomes necessary, which leads to a considerable administrative burden.  

Osborne Clarke comment 

Even if the simplification of the entire authorisation procedure as well as the idea of an innovative European pharmaceutical industry seems reasonable, it is doubtful whether the submitted pharmaceutical legislation can contribute to the realisation of the intended goals. 

In addition to the simplifications of the authorisation procedure, the reduction of the standard document protection period from eight years to six years is also included in the proposed legislation. Such a reduction of data exclusivity could, however, contrary to the Commission's intention, lead to a weakening of the innovative capacity of the European pharmaceutical industry.  

In a next step, the legislative proposal will be discussed in the Parliament and the Council. It remains to be seen what regulatory changes the pharmaceutical industry will face in the future.