Spanish MEPs hope for ‘balance’ between incentives and access in pharmaceutical reform

Spanish MEPs from different political groups hope to find a balance between incentives for industry innovation and equal access to medicines as EU lawmakers work on a revamp of the pharmaceutical legislation.

The European Parliament has been debating the proposed revision of the European pharmaceutical strategy the Commission presented in April.

The deadline for delivering amendments to the Committee on the Environment, Public Health and Food Safety is 13 November for the regulation and 14 November for the directive.

The Commission’s proposal builds on the Pharmaceutical Strategy for Europe communication the Commission adopted on 25 November 2020.

Dolors Montserrat, Spanish Christian democrat MEP, led the Parliament’s report on a pharmaceutical strategy for Europe. She believes the report “sets the course” of the current discussion on the Commission’s proposal.

Montserrat told EFE the current legislative review must “decouple incentives for intellectual property from continued access and supply”, and stressed that her political group’s priority is to “strengthen the current intellectual property framework, regulatory data protection incentives and market exclusivity for orphan medicines”.

Montserrat argued that these differences could be reconciled if “all stakeholders are involved” and believes that the reform should be “addressed as a whole and in a comprehensive way”.

“This legislation has to be a victory for both patients and public health systems so that Europe is a place with a solid legal framework that gives stability to industries and the European market,” she said.

On stakeholder involvement, Susana Solís, Spanish MEP from centrist liberal Renew Europe, argued that “the most controversial thing” in the parliamentary debate “will be to find a balance between everyone”.

Solis said it was “important to listen to the innovative pharmaceutical industry but also to the generic and biosimilar industry (…), as well as to patients’ associations”.

This balance, she said, is “essential for the future of European health,” as it will provide competitiveness and at the same time “access to innovative medicines in the case of cancer, rare diseases, gene therapies, antimicrobial resistance”.

Another Spanish MEP, Nicolás González Casares from S&D, underlined the need to update current legislation, which represents “the first update of this regulatory framework in 20 years” and has two main objectives: to achieve “good accessibility to medicines” and at the same time ensure “pharmaceutical innovation in Europe.”

In this sense, he accepted that “what is really under discussion” in the reform is “the intellectual property of medicines”, i.e. “the time during which the exclusivity of sale for laboratories is guaranteed”.

On this issue, Margarita de la Pisa of the European Conservatives and Reformists Group for Vox, argued that it makes no sense to improve accessibility by “conditioning the incentive,” because if this issue is neglected, “patients are left unattended.”

“Disincentivising innovation is to disincentivise the possibility of treatments for diseases that do not exist today,” she said.

De la Pisa argued that with this new incentive scheme proposed by the Commission, there is a concern about a possible decrease in the development of new medicines in Europe and a transfer of that innovation “to other places.”

Currently, Europe is governed by a system of regulatory data protection for innovative drugs of eight years plus two years of market protection, with the possibility of a further extension, which ultimately gives a period of protection of 10 or 11 years before the entry of generic drugs.

The new regulation proposes a minimum period of regulatory protection of eight years, which includes six years of data protection and two years of market protection.

Additional periods of protection are given for those that meet certain criteria, such as introducing medicine in all member states, addressing unmet medical needs, or conducting comparative clinical trials. Overall, this can increase the total period to up to 12 years.

But according to De la Pisa, the proposal of extending the protection based on these criteria is “open to interpretation” and therefore “provides legal uncertainty” when developing a drug.

“There is a lot more work to be done to ensure that this pharmaceutical legislation is the tool we need in Europe,” she said, stressing that it should favour patients, “those with a vocation for research,” and the industry so that it can develop and not be dependent on third parties.

A “tight” legislative timetable ahead of the plenary session

The four interviewees agreed that their respective political groups will present the amendments to the pharmaceutical legislative review in time for the penultimate plenary session of the current term next April, given that the European elections will be held from 6 to 9 June.

However, they all said that the European Commission proposal arrived with many delays, which meant the European Parliament had to work to a tight schedule and with the possibility of not finalising the revision in this mandate.

“We want to have all the amendments to the text in November and be able to vote on it in the penultimate plenary session of the term (….) but considering the complexity of this legislation of more than 400 articles, the timetable is very tight,” said Solís from Renew Europe.

For her part, Montserrat also said that it was in her group’s interest that “the package comes out in this legislature”, but clarified that the European Parliament needs the Presidency of the Council of the EU, currently held by Spain, to also “be pushing it”.

The acting Spanish health minister, José Manuel Miñones, acknowledged on 23 October that during the six-month Spanish presidency, there would not be enough time to achieve a breakthrough on pharmaceutical reform, given the “complexity” of the matter.

Montserrat said that health “has not been one of the main priorities” for the Spanish presidency. “If it had been, the pharmaceutical legislative review would probably have more chance to succeed.”

[Edited by Giedrė Peseckytė/Zoran Radosavljevic]