Home Pharmaceutics Innovation or stagnation? Europe’s pharma industry at crossroads ahead of rule overhaul – EURACTIV.com

Innovation or stagnation? Europe’s pharma industry at crossroads ahead of rule overhaul – EURACTIV.com


War, the COVID-19 pandemic and vulnerable supply chains are pushing the EU to be more resilient and self-sufficient in pharmaceutical production. Reviewing existing legislation offers the possibility of unlocking investment and research in this area.

Europe’s pharmaceutical industry has warned that the bloc is lagging behind in innovation and losing its position in the global market.

For example, pharmaceutical research in the American industry grew twice as fast as that in Europe between 2017 and 2019.

The disparities between the United States and Europe are also evident from the perspective of patients who are concerned about the accessibility of new drugs.

Currently, it takes an average of 150 days longer to get an innovative drug approved in Europe than in the United States – a delay that could be crucial for some patients.

As Sini Eskola, Director of Regulatory Strategy for the European Federation of Pharmaceutical Industries and Associations (EFPIA) stated, 48% of innovative medicines are currently developed in the United States, while in Europe it is only 22%.

The main focus should therefore be on supporting the resilience and growth of the industry, said Heike Prinz of pharmaceutical giant Bayer.

A unique opportunity in 20 years

The EU currently finds itself at a crossroads represented by the bloc’s upcoming pharmaceutical legislation review. The new legal framework should guarantee access to affordable and quality medicines, make the pharmaceutical system more resistant to crises and increase the security of supply.

The review will also emphasize innovation, a crucial component for the industry. The new legislation could reduce the regulatory burden and help in areas where diagnosis, prevention or treatment is insufficient.

“But development can either be for innovation or for stagnation,” warned Bayer’s Prinz

In particular, representatives of the innovative pharmaceutical industry are calling for more flexibility, which will make it easier for innovative technologies to enter the market and should help to improve the availability of medicines.

This should also be addressed in the review, as the European Commission has stressed that the new legal framework for pharmaceuticals should now be adapted to new scientific and technological developments.

“It is extremely important that people coming directly from the industry can participate in the legislative process. A bad decision would affect the entire sector for the next 20 years”, underlined Nathalie Moll, director of the EFPIA, during a pharmaceutical strategy conference organized in the Czech Senate before the start of the Czech EU Presidency.

According to the Commission’s provisional work programme, the initiative will be presented in December 2022.

Digitization of the health sector

In order to be adaptable and able to respond to new challenges, the EU must also keep an eye on current trends and fill market gaps. One of them could be, for example, biotechnology, in which the EU currently invests little.

Another, even more important, is the area of ​​data. This is what should be the next step towards European resilience, in particular through the digitization of the health system and the sharing of health data. It is by sharing and making data comparable that countries can better identify the sources of problems and solve them effectively.

However, data sharing is currently only voluntary. The legislative proposal for a European Health Data Area presented by the Commission last March aims to change this.

Work will be taken over by the Czech EU Presidency in the second half of 2022.

Given the timing of the process, it is important to continue the work already started, said Antonius Rodiadis of the European Commission’s Directorate-General for Health (DG Health).

The Czech Republic’s key role will be to draw the attention of EU health ministers to individual member states and the implementation of legislation at national level.

[Edited by Gerardo Fortuna and Benjamin Fox]