EU reaches agreement on comprehensive reform of drug legislation

Main content and key changes:

Although the full text of the agreement has not yet been published, the press releases from the European Council and the European Parliament have identified key areas for reform:

Currently, the agreement still requires formal approval from the European Parliament and the Council, and will take effect after being published on the official EU channels. The new regulations are expected to be implemented by mid-2026, with a 2-3 year transition period. The European Commission will also set up a dedicated platform webpage to provide guidance for the implementation of the new regulations. China pharmaceutical companies need to closely monitor changes in EU market access policies, optimize their supply chain layout and innovation strategies in a timely manner, and better respond to the opportunities and challenges brought by the new regulations.

 Source: Medical Insurance Chamber of Commerce compiled and organized according to the European Parliament notice

1. The most contentious aspect of the regulatory data protection and market protection period reform concerns the oversight of innovative drug data and market safeguards. The agreement stipulates that the standard regulatory data protection period for new drugs remains at 8 years (during which competitors cannot reference the originator's data for market approval), while the additional market protection period is reduced from 2 years to 1 year (during which generic drugs or biosimilars are prohibited from being sold). Compared to the initial proposal of a 6-year baseline, the total baseline protection period approaches current levels, which is seen as a concession to the pharmaceutical industry and helps maintain the competitiveness of the EU's pharmaceutical sector.

Meanwhile, the EU incentivizes companies to address specific public health needs through conditional extension of regulatory protection periods. For instance, all EU member states may grant additional extensions for launching drugs, addressing unmet medical needs, conducting controlled clinical trials, or adding new indications, with a maximum total regulatory protection period of 11 years. Breakthrough orphan drugs for currently untreated conditions may enjoy a market exclusivity period of up to 11 years.

The agreement also introduces a Transferable Exclusivity Voucher (TEV), granting companies developing novel antimicrobial drugs an additional year of market protection. The voucher can be transferred to their own or other products, but not to those with annual sales exceeding €490 million in the first four years, thus avoiding strain on the national healthcare budget.

The agreement also seeks to expand the scope of the Bolar exception for generic drug manufacturing infringement, permitting generic manufacturershttps://www.jxserum.com/generic-medicines/ to conduct essential trials during the original patent's protection period. These trials may include pricing preparations, reimbursement applications, and tender submissions in public bidding processes, thereby accelerating market access after the patent expires.

2. Addressing antimicrobial resistance (AMR) The protocol establishes stricter measures to promote prudent antimicrobial use: all antimicrobialshttps://www.jxserum.com/hot-product-list/ must be sold with prescriptions; marketing applications require submission of an antimicrobial stewardship plan, with mandatory inclusion of resistance risk assessment in environmental risk evaluations; packaging and drug labels must include specific information, and if only electronic versions are available, a printed awareness card must be provided to promote rational medication use and public awareness.
3. Drug Shortage Management and Pharmaceutical Supply Chain Security Agreement significantly enhance the prevention and response to drug shortages. Marketing authorization holders must develop and regularly update shortage prevention plans, notifying potential shortages at least six months in advance. The European Medicines Agency and national authorities will monitor shortage situations, assess supply chain vulnerabilities, establish a list of critical EU medicines, and strengthen cross-member state coordination.
4. Regulatory Restructuring and Procedural Streamlining The EMA's regulatory framework will be streamlined to expedite marketing authorization applications. The Human Medicines Committee (HMC) will be consolidated into two entities: the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC). The marketing authorization review period will be reduced from 210 days to 180 days, with enhanced evaluation resources for drug developers. Digital solutions will be implemented, including standardized electronic submission formats and QR code-based patient information. Marketing authorizations will be granted with indefinite validity by default, eliminating administrative burdens associated with renewals (though the EMA may impose temporary validity limits for safety reasons).
5. Other measures: The agreement further requires enterprises to disclose information on public funding support obtained during R&D to enhance transparency, and to strengthen environmental risk assessment and sustainability standards for pharmaceuticals.
6. Impact and Outlook:

    The EU's pharmaceutical policy reform aims to reduce disparities among member states and improve patient access to medications. It plans to introduce a series of innovative incentive measures, particularly targeting unmet medical needs in areas such as novel antimicrobial agents, pediatric drugs, and treatments for rare diseases. EU stakeholders have acknowledged that the protection periods in the reform have not been significantly reduced. However, some critics argue that the current incentives remain insufficient to fully attract global R&D investment. Additionally, the reform has made limited progress in enhancing price transparency and affordability, failing to address member states' pricing sovereignty.

   Currently, the agreement still requires formal approval from the European Parliament and the Council, and will take effect after being published on the official EU channels. The new regulations are expected to be implemented by mid-2026, with a 2-3 year transition period. The European Commission will also set up a dedicated platform webpage to provide guidance for the implementation of the new regulations. China pharmaceutical companies need to closely monitor changes in EU market access policies, optimize their supply chain layout and innovation strategies in a timely manner, and better respond to the opportunities and challenges brought by the new regulations.