EFPIA reaction to European Parliament plenary vote

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has shared its perspective on the European Parliament plenary vote. The Members of the European Parliament (MEPs) adopted their position on the EU on 10 April 2024.  

EFPIA explained that while some improvement to the original European Commission proposals were made, certain additional changes must be implemented to support the EU’s position, EFPIA noted.

“This is a significant moment for the research based pharmaceutical industry… Ensuring patients have faster, more equitable access to new medicines – and how Europe can close the investment gap on other parts of the world – has been the subject of significant debate in the past months,” commented Nathalie Moll, Director General of the EFPIA.

Moll continued, noting that EFPIA believes the Parliament’s vote “through certain amendments that have enhanced the European Commission’s original proposals to develop a future-proof regulatory framework… [is a] “move welcomed by industry”.

She explained that MEPs avoiding “making two years of a company’s regulatory data protection (RDP) dependent on a new medicine being available in all 27 EU Member States within two years of getting marketing authorisation”, is a logical decision.

Importantly, they “recognised that the majority of factors determining whether a medicine is made available or not, are out of the control of an individual company.”

EFPIA on supporting Europe’s competitiveness

However, “despite some improvement to the original European Commission proposals, the position adopted in the plenary reduces regulatory data protection by six months. It is difficult to understand how reducing incentives to research, develop and manufacture new medicines and vaccines could ever be in the best interest of Europe or European patients”.

This is important to consider when working to increase Europe’s competitiveness. As such, Moll argued that this will be a challenge for policy makers working on the subsequent revision of the pharmaceutical legislation. She believed it can be achieved by implementing “coherent and complimentary” policies that will “strengthen the research based pharmaceutical industry in all Member States”.

Additional response to the vote by the EFPIA discussed regulation, vaccines and medicines shortages in the EU:

Regulation

“A regulatory sandbox is a big step towards future-proofing the regulatory framework”. Yet to increase its effectiveness for “future breakthrough innovations” in the EU, the sandbox should be “applicable across several legislative frameworks and not limited to the pharmaceutical legislation”.  

The EFPIA also stated that a significant step in addressing antimicrobial resistance (AMR) is the “European Parliament’s inclusion of AMR incentives, such as the transferable exclusivity voucher (TEV) in its text.” However, to ensure the measures are effective, they should be further refined in future negotiations, the organisation asserted.

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Vaccines 

EFPIA welcomed the adopted vaccine definition, acknowledging its alignment to EMA guidelines on vaccines assessment. It also “allows for future innovation in the field of immunisation.… [however] we regret not to see vaccines specificities fully covered by the adopted texts, especially when it comes to the obligation to file for a pricing and reimbursement procedure, which could lead to a suboptimal and unequal access to immunisation”. 

EU medicines shortages 

Considering the medicines shortages that have impacted the EU supply chain, EFPIA deemed that including “the possibility for the European Medicines Agency to assess Member States’ measures to tackle shortages and how they impact on other countries” in the text approved by the Parliament is “positive”.

Although, EFPIA communicated that having no plans to use data from the Falsified Medicines Directive (EMVS) to monitor shortages, “is a missed opportunity”. 

Furthermore, in helping to mitigate supply chain disruptions, shortage prevention plans (SPPs) should be reserved for critical medicines, according to EFPIA. The organisation asserted that the vote, which sought to extend the current two-month notification period for temporary supply chain to six months, “will likely lead to unnecessary notifications which could reduce visibility of actual shortages”.

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