Spanish MEPs hope to strike a balance between incentives and affordability in pharmaceutical reform.

Madrid (EuroEFE).- European parliamentarians from different political groups who recently gathered at a meeting organized by OncoLAB, an initiative supported by AstraZeneca, said in an interview with EFE that they favor a "balance" between innovative industry incentives and equal access to medicines for the entire market in the revision of pharmaceutical legislation.

This interpretation regarding the combination of both factors presented in the European Commission's (EC) April proposal arose because the European Parliament (EP) is in full political debate to submit amendments to the Committee on Environment, Public Health and Food Safety (ENVI) 14''The MEP points out that these differences can be reconciled if "all stakeholders are involved" and believes that the reform must be "holistic and global". "This legislation must be a win for both patients and public health systems to make Europe an area with a strong legal framework that provides stability for industry and the European market," she adds.

With regard to stakeholder engagement, the MEP of the Renew Europe political group from the Ciudadanos party, Susana Solis, argues that "the most controversial thing" in the parliamentary debate will be to "find a balance between everyone". She therefore considers it "important to listen to the innovative pharmaceutical industry, as well as''the generic and biosimilars industry (...) as well as patient associations'. She emphasizes that this harmony is "essential for the future of European healthcare" as there will be "competitiveness" and at the same time "availability of innovative medicines in the case of cancer, rare diseases, gene therapy, antimicrobial resistance".

Euro MP of the Progressive Socialist Union (S&D) group, Nicolás González Casares, defends the need to unlock this reform, which would be "the first update of this regulation in 20 years". And points to two main objectives: achieving "good accessibility to medicines" and at the same time achieving "pharmaceutical innovation in Europe". In this context, he recognizes that "what''really discussed' in the reform is the 'intellectual property of medicines', that is, 'the period during which laboratories have exclusive sales rights'. On this topic, the MP from the Vox party, Margarita de la Pisa, argues that "it makes no sense" to improve accessibility by "dependence on the incentive", because if this issue is not taken into account, it somehow "leads to patients being ignored".

At present, Europe''is guided by a system of data regulation of innovator drugs for 8 years plus an additional 2 years of market protection with the possibility of expansion, resulting in a total of 10-11 years of protection until generic drugs become available. The new legislation proposes to shorten that scheme to 8 years, with the possibility of partially restoring the protection if certain requirements are met, which include, according to de la Piz, "interpretation of susceptible" concepts that "create legal uncertainty" in drug development. "We have much more work to do to make this pharmaceutical legislation the tool we need in Europe," says the MEP, and emphasizes that it must be beneficial for "patients", for "people with an attraction to research" and for'''industry'' so that it can develop and ''not be dependent on third parties''.

Ordering a LEGISLATIVE CALENDAR FOR ADDRESS IN THE COURT OF THE SESSION:

All four respondents agree that their political groups will present amendments to pharmaceutical legislation on November 14 to try to get them through to the penultimate meeting in April, as the EU elections take place between June 6 and 9. However, they argue that this proposal from the European Commission has come with major "delays", resulting in the EP working to a "set timetable" and with the possibility that this review "will not be finalized this term". "We want all amendments to the text to be submitted in November so that it can be voted on at the penultimate''all European citizens,' the MEP adds and concludes that otherwise inequalities in access between countries in the European area will continue.

Edited by Lucia Leal