Pharmaceutical package: the EU needs to be more strategic

The long-awaited updating of EU pharma legislation offers potential benefits for Europeans but should give more consideration to strategic autonomy

The proposed revamp of EU regulation relating to the vital pharmaceuticals sector is welcome, says the EESC, but it should put greater weight on broader social and geopolitical concerns in addition to its focus on ensuring that the industry remains competitive and attracts investment.

We need to achieve strategic autonomy and for that we need security of supply. Administrative and financial incentives have to be developed, says Martin Schaffenrath, rapporteur of the EESC opinion on the Commission’s proposal.

We need investment in this sector. We need sustainable support for this area. And we need to bring back production, which has been outsourced to other countries.

The European pharmaceuticals industry is one of the largest and most economically important industries in the European Union, employing around 840 000 people directly and generating three times as much employment indirectly. In 2021, the industry invested an estimated EUR 41 billion in research and innovation. The opinion makes clear that supporting the sector as a high-tech cornerstone of the EU economy should be at the heart of the Union’s long-term approach.

We have tried to emphasise how essential measures are for strengthening pharmaceutical research and development in the EU, the rapporteur says.

We need effective measures in order to promote pharmaceutical innovation, particularly in areas which have been neglected in the past and also for orphan medicines, for rare diseases.

Strategic autonomy

With the Commission’s proposal coming in the wake of the devastating Covid-19 pandemic, the EESC uses its opinion to set out its views on making Europe less dependent on third countries for manufacturing of drugs and the supply of key pharmaceutical components.

The Committee endorses offering incentives to favour drug manufacturers in the EU and to encourage the relocation of production from non-EU countries in order to reduce external dependency. It also proposes the establishment of a European contingency reserve of medicines of strategic importance.

As for the shift in production in the pharmaceutical industry, we have to bring production back here. This is a huge problem which we will have to turn around, says Mr Schaffenrath.

An EU fund for rare diseases

An equitable approach to strategic autonomy is a common thread throughout the EESC’s opinion. It calls for an expanded approach to the joint purchasing of medicines in the EU, leveraging the savings potential from bulk purchases, and points to the successful procurement and development of Covid-19 vaccines across the Union as an example of the potential of this approach.

Focusing on the social importance of regulatory revision, the opinion also suggests the creation of a special EU-level fund to ensure access to treatment for all patients in Europe suffering from rare diseases. The purpose of such a fund would be to take into account disparities in healthcare provision between Member States, such as when statutory health insurance does not cover the entire cost of treatment.

Read the EESC opinion on the draft pharmaceutical package