Deal on comprehensive reform of EU pharmaceutical legislation

Promoting innovation and increasing access to medicinal products across the EU

Combatting antimicrobial resistance

Optimising European Medicines Agency’s structure and simplifying regulatory procedures

Improving monitoring and management of shortages

Early morning on Thursday, co-legislators reached a provisional agreement on revamping the EU’s pharmaceutical policy framework, to boost competitiveness, innovation and security of supply.

Regulatory data and market protection to support innovation

Parliament and Council negotiators agreed to a regulatory data protection period (during which other companies cannot access product data) of eight years, with one additional year of market protection (during which generic or biosimilar products cannot be sold), following a marketing authorisation.

Pharmaceutical companies would be eligible for additional periods of market protection:

if the particular product addresses an unmet medical need (12 months);

if it contains a new active substance, fulfilling a combination of conditions on comparative clinical trials, clinical trials carried out in several member states, and the obligation to apply for market authorisation within 90 days after the submission of the application for the first marketing authorisation outside the Union (12 months);

if the company obtains an authorisation for one or more new therapeutic indications that bring a significant clinical benefit in comparison with existing therapies (12 months).

The deal envisages a cap of eleven years on the combined regulatory protection period.

Orphan medicinal products addressing a disease with no current available medicinal treatment (“breakthrough orphan medicinal products”) would benefit from up to eleven years of market exclusivity.

To support earlier market entry of generic and biosimilar medicinal products, the deal clarifies the scope of the “Bolar” exemption (which allows manufacturers to conduct certain activities during the market protection period of the original product). Patent rights would not be infringed when necessary studies, trials and other activities are conducted for the purposes of obtaining marketing authorisations, conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications.

Stepping up the fight against antimicrobial resistance (AMR)

Negotiators agreed to introduce a “transferable data exclusivity voucher” for priority antimicrobials, giving the right to 12 additional months of data protection for one authorised product. The 12-month extension may be used once, for the priority antimicrobial or for another centrally authorised medicinal product of the same or different marketing authorisation holder.

Among new measures to promote the prudent use of antimicrobials, the deal introduces stricter requirements, such as compulsory medical prescriptions for all antimicrobials, specific information requirements to be provided with the package leaflet, and an “awareness card” in paper format in case the leaflet is made available only electronically.

When applying for marketing authorisation for antimicrobials, companies would also need to provide an “antimicrobial stewardship plan” and include an evaluation of the risk for antimicrobial resistance as part of the compulsory environmental risk assessment.

Competitive regulatory framework

The updated rules would simplify the European Medicines Agency’s (EMA) internal functioning, to enable it to treat market authorisation requests more rapidly. Marketing authorisation applications would be submitted electronically in a common format. Marketing authorisation for a medicinal product would be valid by default for an unlimited period, avoiding the unnecessary administrative burden linked to renewals (the EMA would still have the possibility to limit validity, on safety grounds).

Under special conditions, the Commission may set up regulatory sandboxes, to allow the development and testing of new and innovative therapies, under the direct supervision of the competent authorities.

Ensuring the availability of medicines

Companies holding marketing authorisations for medicinal products would be required to put in place and update shortage prevention plans for medicinal products subject to prescription and medicinal products that would require a shortage prevention plan identified by the Commission. Shortages would be monitored at both national and EU levels, and the EMA would establish and update a list of critical shortages in the EU.

Press conference

MEPs Adam Jarubas (public health committee chair), Tiemo Wölken (regulation rapporteur) and Dolors Montserrat (directive rapporteur) will hold a press conference on Thursday 11 December, at 9.30 CET, in Parliament’s Anna Politkovskaya press conference room (SPAAK 0A50) in Brussels.

Accredited journalists can attend the press conference in person, while those wishing to participate actively and ask questions remotely can do so via Interactio. The press conference will be streamed live and be made available on Parliament’s Multimedia Centre.

Next steps

Parliament and Council have concluded an "early second reading agreement" (negotiation took place after Parliament’s first reading was adopted in plenary). The Council is now expected to formally adopt its position, which can then be endorsed by Parliament in second reading.

Background

On 26 April 2023, the Commission put forward a pharmaceutical package to revise the EU's pharmaceutical legislation. It includes proposals for a new directive and a new regulation, which aim to make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, and raising environmental standards.