European Parliament adopts pharmaceutical reform package

The European Parliament has voted to adopt a pharmaceutical reform package that includes new legislation and regulations in the first major overhaul of the EU’s pharmaceutical rules in two decades. The Parliament said the package is intended to encourage innovation in the economic zone, though the compromise reform package has received criticism from both consumer and pharmaceutical groups.

The European Parliament voted 495 to 57 with 45 abstentions to adopt the revised pharmaceutical legislation and 488 to 67 with 34 abstentions to adopt a new regulation. The move comes roughly a year after the European Commission released its draft proposal for the pharmaceutical reforms.

With its position adopted, the new Parliament will meet to discuss the legislation again after the 6-9 June European elections and the European Council must approve the legislative package before negotiations on a final deal can take place.

“The revision of the EU pharmaceutical legislation is vital for patients, industry and society,” said Member of Parliament (MEP) Pernille Weiss, EPP – DK, rapporteur for the directive. “Today’s vote is a step towards delivering the tools to tackle present and future healthcare challenges, particularly for our market attractiveness and access to medicine across EU countries.”

“We hope Council takes note of our ambition and commitment to create a robust legislative framework, setting the scene for effective negotiations,” she added.

If the legislation and regulations are adopted as is, drugmakers will have at least seven and a half years of regulatory data protection after receiving marketing authorization, down from eight years under the current legislation, in addition to two years of marketing protections for their drugs against rival companies that may want to manufacture generics, hybrids, or biosimilars.

Drugmakers could also get additional data protection depending on several factors, such as the type of drug and how it was developed. For instance, drugs that address an unmet medical need could get an additional year; if the drugmaker conducts a comparative clinical trial, they could receive an additional six months; and if the drug research and development is significantly European-based and it is developed in collaboration with EU research entities, it could get another six months of data protection.

The Parliament also wants to set a maximum data protection limit of eight and a half years. If the drugmaker receives marketing authorization for the drug for an additional indication that provides significant clinical benefits over existing treatments, it could be eligible for a one-time one-year extension of the two-year marketing protection.

Orphan drugs that address a high unmet medical need are given special consideration as they could get up to 11 years of market exclusivity under the proposed legislation.

The legislation also addresses a major global health concern with the rise of infections from antimicrobial resistance (AMR) and the lack of new antibiotics to treat them.

“To boost research and the development of novel antimicrobials, MEPs want to introduce market entry rewards and milestone payment reward schemes (e.g. early-stage financial support when certain R&D objectives are achieved prior to market approval),” the EU parliament said in a statement. “These would be complemented by a subscription model scheme through voluntary joint procurement agreements, to encourage investment in antimicrobials.”

“They support the introduction of a ‘transferable data exclusivity voucher’ for priority antimicrobials, providing for a maximum of 12 additional months of data protection for an authorized product,” it added. “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.”

The European Federation of Pharmaceutical Industries and Associations (EFPIA) had a mixed response to the news, stating that while the Parliament's package is an improvement compared to the Commission’s proposal, it falls short of its objectives. EFPIA Director General Nathalie Moll said the votes were a "significant moment" for pharmaceutical research but bemoaned that legislators reduced the data protection timeframe to seven and a half years from eight years under current legislation.

“Despite some improvement to the original European Commission proposals, the position adopted in the plenary reduces regulatory data protection by six months,” said Moll. “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 recognizes that it needs to boost competitiveness to compete for global investment with ambitious nations like the US and China.”

EFPIA also said it would have preferred if legislators had used other incentives for orphan drug development instead of a graduated high unmet medical need (HUMN) system that would have been simpler and more predictable and would have considered the unique challenges of the drugs being developed. It also said that the EU needs to update the current legislation to encourage pediatric drug development, especially for unmet needs.

"The introduction of pediatric investigation plans (in the legislation) 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 pediatric patients and does not place undue burden on pharmaceutical innovation," said Moll. "Furthermore, this ecosystem needs to make pediatric medicines available where actual patient needs and demands exist across the EU."

EFPIA also addressed other areas for improvement in the legislation where it thinks it fell short, including vaccines, drug shortages, and compliance with good manufacturing practices (GMP). The group, however, praised legislators for being "pragmatic" by not requiring a drug to be available in all 27 EU member states as a prerequisite for receiving the full seven and a half years of regulatory data protection.

“They have recognized that the majority of factors determining whether a medicine is made available or not, are out of the control of an individual company,” said Moll. “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.”

EU statement

EFPIA statement

European Parliament adopts pharmaceutical reform package

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