AseBio expects new improvements in the EU Pharmaceutical Legislation proposal that ensure biotechnological innovation, following the voting on amendments in the April plenary session

On March 19th, the Committee on Environment, Public Health and Food Safety of the European Parliament adopted its position on the new directive regulating human medicinal products with 66 votes in favor, two against, and nine abstentions. With this step, MEPs support the renewal of the General Pharmaceutical Legislation of the European Union (GPL), aiming to promote innovation and improve the security of supply, accessibility, and affordability of medicines.

On April 26, 2023, the Commission presented a "pharmaceutical package" to revise EU pharmaceutical legislation. This includes proposals for a new directive and a new regulation, aimed at making medicines more available, accessible, and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, in compliance with higher environmental standards.

MEPs are expected to debate and vote on the Parliament's position during the plenary session on April 10th and 11th, 2024. The new Parliament will deal with the file after the European elections from June 6th to 9th.

From AseBio, we advocate for European pharmaceutical policy to support and serve as a driving force to ensure that patients, society, and the European economy can fully benefit from biotechnological innovations. In this regard, a recent study published by EuropaBio warned of the risk that the GPL could pose to biotechnological innovation in Europe, particularly negatively impacting small companies.

From AseBio, we continue to follow with interest the legislative process of the GPL, whose progress we positively value. We emphasize the need to protect and particularly watch over small companies, which make up the majority of the innovative biotechnological fabric in the European Union, through a framework that allows them to take risks and thrive by attracting investments. This is a key aspect, as reducing incentives for innovation and overcomplicating them could jeopardize the foundations upon which the biotechnological innovation ecosystem works. We will remain attentive to the next steps with a focus on the debate and vote in the plenary session to be held on April 10th and 11th.

EU Pharmaceutical Policy: What do MEPs Support?

With the aim of incentivizing innovation, MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid, or biosimilar products cannot be sold), subject to marketing authorization.

Pharmaceutical companies would be eligible for additional data protection periods if the particular product addresses an unmet medical need (+12 months), if comparative clinical trials are conducted for the product (+6 months), and if a significant portion of the product's research and development is conducted in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a limit on the combined data protection period of eight and a half years.
A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains marketing authorization for an additional therapeutic indication, providing significant clinical benefits compared to existing therapies.

Orphan drugs (medicines developed to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a "high unmet medical need."
MEPs emphasize the need to boost research and development of new antimicrobials, particularly through market entry incentives and milestone payment schemes (e.g., financial support in early stages upon reaching certain R&D milestones before market approval). These would be complemented by a voluntary joint procurement plan based on a subscription model, to encourage investment in antimicrobials.

They also agree on introducing a "transferable data exclusivity voucher" for priority antimicrobials, providing a maximum of an additional 12 months of data protection for an authorized product. The voucher could not be used for a product that has already benefited from maximum regulatory data protection and would be transferable only once to another marketing authorization holder.

Among the new measures to promote prudent use of antimicrobials, MEPs want stricter requirements, such as restricting prescription and dispensing to the amount necessary for treatment and limiting the duration of their prescription.

These new regulations would require companies to submit an Environmental Risk Assessment (ERA) when applying for marketing authorization. MEPs insist that risk mitigation measures (taken to prevent and limit emissions to air, water, and soil) must address the entire life cycle of medicines.

To effectively address public health challenges and drive European research, MEPs want the European Health Emergency Preparedness and Response Authority (HERA, currently a department of the Commission) to become a separate structure under the European Centre for Disease Prevention and Control (ECDC). This way, HERA should focus on combating the most urgent health threats, including antimicrobial resistance and medicine shortages.