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EFPIA responds to the European Parliament Plenary vote:

Despite improvements, the Pharma-Legislation has a long way to go to restore Europe’s competitive edge.

On 10 April 2024 Members of the European Parliament adopted their position on the EU Pharmaceutical Legislation.

Commenting on the vote, Nathalie Moll, EFPIA Director General, said:

“This is a significant moment for the research based pharmaceutical industry. Today’s vote sets out how Europe sees the future of health and life science research and innovation and patient care in the region.

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.

We believe that the Parliament has voted through certain amendments that have enhanced the European Commission’s original proposals to develop a future-proof regulatory framework. A move welcomed by industry.

MEPs have also taken the pragmatic, common sense step to avoid making two years of a company’s regulatory data protection (RDP) dependent on a new medicine being available in all 27 EU members states within 2 years of getting marketing authorisation. They have recognised that the majority of factors determining whether a medicine is made available or not, are out of the control of an individual company. Rather than waiting for legislation that is not designed to address medicines access in Member States, we are convinced that by getting around the table with patients, payers, providers and national policy makers, we can find workable solutions to improve access for patients today.

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, particularly at a time when Europe recognises that it needs to boost competitiveness to compete for global investment with ambitious nations like the US and China.

The challenge now is for policy makers to align the next iteration of the pharmaceutical legislation with the recurrent calls by European leaders to boost European competitiveness and build a resilient industrial future. As the industry that contributes more to the EU trade balance than any other sector, we believe that health and life sciences should be at the heart of building that future.

 This can only be achieved through the implementation of coherent and complimentary policies within the revision of the Pharmaceutical Legislation that will strengthen, not weaken the research based pharmaceutical industry in all member states.”

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Further EFPIA commentary on individual aspects of the Plenary vote

On the regulatory framework

“Retention of the Commission’s proposals to introduce a regulatory sandbox is a big step towards future-proofing the regulatory framework. The effectiveness of the sandbox provisions in helping bring future breakthrough innovations to EU patients could be maximised by ensuring the sandbox is applicable across several legislative frameworks and not limited to the pharmaceutical legislation.

 Administrative burden will be reduced with the proposal of electronic-only patient information for medicinal products directly administered by healthcare professionals. However, we are missing an opportunity by not giving the European Commission the power to determine when the time is right for all leaflets to be available electronically only. EFPIA does, however, believe that wherever necessary, a paper leaflet should also be available for those patients who need it.

On Antimicrobial Resistance (AMR) and the retention of TEV proposals

“The European Parliament’s inclusion of AMR incentives, such as the transferable exclusivity voucher (TEV) in its text marks a significant step in addressing the AMR challenge. It will be important for these measures to undergo further refinement during legislative negotiations to ensure their effectiveness.

The revision of the pharmaceutical legislation offers a unique chance for Europe to take a leadership position in the global fight against AMR. We look forward to continued conversations with all partners to identify policy solutions capable of realising this goal.”

On orphan medicines

“Robust and reliable incentives remain essential. In order to address the needs of patients suffering from rare diseases, incentives should be strengthened as the economic case for investment in rare diseases is only marginal.

A simple and predictable system of orphan incentives with a strengthened market exclusivity baseline, and modulation that considers the specific challenges related to a given type of development, without using the graduation of HUMN, would have been the better choice for European Rare Disease patients. We hope that Member States will consider these key ingredients and enable an improved ecosystem for research and development of solutions for rare disease patients.

It is great to see that the idea of a European Framework for Rare Diseases is included to foster more coordination of policies and programmes.”

On the definition of Unmet Medical Need (UMN)

“We are pleased to see that under the European Parliament proposals, all relevant stakeholders will be invited to actively engage in identifying unmet medical needs from different perspectives. To ensure a patient-centric definition, the value of innovation has to be acknowledged and advances in prevention, treatments and care encouraged.”

On paediatrics

“In the field of paediatrics, we need to build on the current legislation and create an ecosystem fostering effective research into medicines for children, particularly where unmet medical need exists. The introduction of paediatric investigation plans based on mechanism of action is a step in the right direction, but this so far lacks the appropriate framework to ensure that the expanded research obligations lead to scientifically and clinically meaningful, and feasible R&D that benefits paediatric patients and does not place undue burden on pharmaceutical innovation. Furthermore, this ecosystem needs to make paediatric medicines available where actual patient needs and demands exist across the EU.”

On vaccines

“We welcome the adopted vaccine definition, as it aligns with the EMA’s guidelines for the assessment of vaccines and allows for future innovation in the field of immunisation. Vaccines are unique medicinal products, with complex manufacturing processes, long lead times and very specific regulatory requirements and market access pathways. For instance, in most of the EU countries, routine vaccines must be listed in the national immunisation programmes to be eligible for a pricing and reimbursement procedure. 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, and therefore, an inadequate protection of the European population.”

On medicines shortages

“There are a number of positive elements within the text approved by the Parliament, including proactive consultation with all stakeholders on the Critical Medicines list, the possibility for the European Medicines Agency to assess Member States’ measures to tackle shortages and how they impact on other countries, as well as plans by the Commission to work with the ECDC to build reliable forecasts of potential threats and shortages. 

However, EFPIA continues to have concerns around a few proposals. There remain no plans to use readily available data from the Falsified Medicines Directive (EMVS) repository to monitor shortages, we believe this is a missed opportunity. Extending the current 2-month notification period for temporary supply chain disruptions to 6 months will likely lead to  unnecessary notifications which could reduce visibility of actual shortages. Shortage Prevention Plans (SPPs) should be reserved for critical medicines.

A new requirement to include labelling information on each individual dose of blister packs, would also lead to significant disruptions in the manufacturing processes.”

On manufacturing

“We are encouraged to see platform technology master files having been adopted by the European Parliament, leading to shorter approval times for innovative medicines.

On the other hand, the proposal to enforce environmental and workers’ safety via Good Manufacturing Practices Inspections risk delays to the approval of medicines in the EU and in third countries, and ending the existing mutual recognition agreements on GMP inspections with non-EU countries.  Asking GMP inspectors to enforce environmental and workers’ safety, when this has already been done by Inspectors  specialised in environmental and workers rules is a waste of resources. This will also be difficult to enforce outside of  the EU / EEA.“

On environmental proposals

“The pharmaceutical industry recognises the importance of Environmental Risk Assessments (ERA) in assessing the potential impact of human medicines and their manufacture on the environment. To proactively address and manage this, we propose an extended ERA to proactively address and manage the environmental risks associated with the patient use of human medicinal products. We do, however, have concerns over provisions adopted by the European Parliament which strengthen the possibility to revoke or refuse a Market Authorisation based on environmental concerns and where the ERA is to cover the full lifecycle of a medicine including manufacturing and opens doors to use EMA quality inspectors to enforce environmental standards in manufacturing outside of the EU.”