Euro Convergence: Experts seek ‘future proof’ pharma legislation as EU elections nears

BERLIN – Experts and stakeholders involved in the discussions over the EU’s pharmaceutical legislation say they are in talks with key players to ensure the upcoming June parliamentary elections don’t disrupt its chances of being implemented.

As part of its Pharmaceutical Strategy for Europe in 2020, the European Commission proposed a comprehensive review of the EU’s pharmaceutical legislation. After multiple delays, the Commission adopted its proposal to overhaul the pharmaceutical framework to include revising the existing legislation and introducing a new regulation last year. In April, the European Parliament adopted a revised package that included some concessions to industry, though work to finalize the deal will continue after the European elections in June. (RELATED: European Parliament adopts pharmaceutical reform package, Regulatory Focus 11 April 2024)

During a panel at the 2024 RAPS Euro Convergence conference, experts gave insight into how the legislation came about, what changes are being proposed, and what the future holds.

While the proposal has come a long way, Rebecca Lumsden, head of regulatory science and policy EU/AMEE at Sanofi, pointed out that European parliamentary elections are coming up in June that could ultimately lead to significant changes in the proposal. She noted that Hungary and Poland, which are set to hold presidency of the EU Council for the next two periods have said they are actively reviewing the legislation.

“Those of us who are interested and engaged on this legislation are now beginning our discussions with the European Council representatives on potential changes to really future proof this legislation because it is a once in a 20-year opportunity for us to make an environment for Europe that's fit for purpose and flexible,” said Lumsden.

She noted that even if the legislation does pass, there will be an 18-month implementation period so it will likely not go into effect until 2027 or early 2028.

Lilia Luchianov, a policy officer at DG SANTÉ at the European Commission, said the proposed legislation is intended to achieve availability, accessibility, and affordability of drugs in the EU. She noted that currently there is a significant disparity in terms of what drugs are available in different member states; she noted that while Germany approved 147 drugs between 2018 and 2021, Malta only approved 10.

"We wanted to solve this issue so that patients are not told anymore that the medicines are not available in their country but also that companies get their reward when they deliver on their public health objectives,” said Luchianov.

Luchianov said the new legislation is intended to make the EU a more competitive market for drugmakers by offering tailoring incentives, such as longer exclusivity, to specific products and streamlining the review process to reduce decision times. She also said the legislation is intended to provide more protection and help bring more drugs to market that serve unmet medical needs.

Alberto Ganan, the head of Committees and Quality Assurance Department at the European Medicines Agency (EMA), gave additional details on how the legislation would enhance and streamline the currently regulatory oversight of medical products in the EU. For instance, he noted that EMA’s Committee for Medicinal Products for Human Use (CHMP) currently has no healthcare professional or patient representatives. Under the proposed legislation, the committee would add at least five healthcare professionals and eight patient advocates to diversify the perspectives included in its reviews. Similarly, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) would double the number of healthcare professional and patient representatives.

Ganan also said that currently standard marketing authorization applications take 210 days to be reviewed by CHMP, but under the proposed legislation those applications should be complete within 180 days and potentially 150 days for certain products. He also noted that while the European Commission takes about 67 days to give a decision, the legislation aims to shorten that to 46 days.

Luchianov and Ganan also mentioned that the legislation proposes new regulatory tools that can help streamline the review process, such as a phased review intended for products that offer exceptional therapeutic advantage for unmet needs, though the European Parliament would like to expand that definition to products that are "expected to be of major interest from the point of view of public health or for conditions with no authorized alternatives in the Union."

Another important tool that is being proposed is a regulatory sandbox that would allow products that address an unmet need but don't have a traditional regulatory pathway.

"[It] is basically a structured environment where you can test a product or a type of product because it doesn't fit into the regulatory box," said Luchianov."[It let's you] see how to deal with that product in a safe manner before you can actually put it on the market."

Julie Spony, a policy officer at the European Patients’ Forum (EPF), a patient advocacy group co-funded by the EU, said the proposed legislation would help patients by incentivizing drug development in the EU, improve access to generics and biosimilars, and increase patient involvement in the regulatory decision-making process.

She also noted that while the European Commission has proposed greater regulatory data protection for drugs that address unmet medical needs, she argued that the limited definition of unmet medical need based on mortality and morbidity isn't enough.

"From a patient perspective, unmet medical need is way more than mortality and morbidity," said Spony. "It encompasses the broader impact of the treatment on the patient's quality of life."

"We also need to ensure that all medicines are tailored to patient needs," she added. "That's why we are calling for the inclusion of patient experience data into the marketing authorization dossier because it would provide invaluable information on the impacts on the outcomes that matter the most to patients."

Sini Eskola, director of regulatory strategy at the European Federation of Pharmaceutical Industries and Associations (EFPIA), pointed out that while the legislation is driven by availability, accessibility, and affordability of drugs in the EU, it is also an important proposal to close the drug research and development gap between the US and EU.

Eskola pointed out that while drug R&D spending in the US was $2 billion more in the US than in the EU in 2002, today drugmakers invest $25 billion more in the US than in the EU.

"It was said a couple of decades ago that Europe is the pharmacy of the world, that is no longer the case," she said. "Almost 50% of the new medicines arrive from the US."

Eskola said the new legislation is an opportunity for the EU to make it more attractive to drug developers and not be left behind by other regulatory regimes.

“This is a once-in-a-generation opportunity to upgrade our system and really ensure that the gap is bridged,” she added.

Eskola said that while the European Commission proposed the updated legislation, and the European Parliament suggested their own changes to the legislation in April, the European Council is in line to consider the proposal. She noted the presidency will go to Hungary in the second half of the year, followed by Poland and Denmark, all of whom have voiced significant interest in concluding the legislation.

One area of concern Eskola raised is the legislation would enforce environmental and workers standards through good manufacturing practice (GMP) inspections. She said it would be very hard to enforce such requirements, especially outside the EU and EEA. She also said that while industry tries to act responsibly, some of the environmental protection penalties in the legislation such as revoking or refusing marketing authorization for failing to meet environmental requirements, are disproportionate.

RAPS Euro Convergence

Euro Convergence: Experts seek ‘future proof’ pharma legislation as EU elections nears

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