The European Commission recently issued multiple proposals focused on perceived shortfalls in the European pharmaceutical industry. The proposals are the most significant changes to the EU’s pharmaceutical regulations in two decades and aims to make medication “more accessible, affordable and innovative” as well as “more agile, flexible, and adapted to the needs of citizens and businesses across the EU.”
What is in the Proposals?
The reform proposals includes a new Directive and a new Regulation, which together create the EU regulatory framework for all medicines. The Directive includes the requirements for authorization, monitoring, labeling and regulatory protection, placing on the market, and other regulatory procedures for medicines authorized at the EU and national levels. The Regulation outlines additional specific rules for medicines authorized at the EU level and sets out rules on coordinated management of critical shortages and security of supply of crucial medicines, as well as sets out the rules that govern the European Medicines Agency (EMA).
The proposals would create a Single Market for medicines, with the goal of allowing patients across the EU to have “timely and equitable access to safe, effective, and affordable medicines,” as well as reduce the administrative burden by speeding up procedures and reducing authorization times for medicines.
The proposals would also shrink the review timelines for drugs, leaving the EMA with only 180 days to review medicines for authorization (instead of the current 210 days). Once the EMA recommends a drug, the Commission has only 46 days (compared to the current 67 days) to approve. In the cases of drugs with a “major public health interest,” the timeline is even shorter. Additionally, “rolling reviews” will be implemented, which will allow for phased reviews of data as they become available.
The proposals also allow for regulatory “sandboxes” which allow testing new regulatory approaches for novel therapies under real world conditions and real-world evidence.
With respect to the drug authorization process, the proposal would allow only two committees of the European Medicines Agency to review efficacy and safety data during drug reviews, while all other committees (including the existing orphan, pediatric, and advanced therapy committees) would be eliminated.
Additionally, once a drug is approved, the Commission proposes shortening the exclusivity period from ten years to eight (six years of data protection and two years of market protection) for most medicines. In an effort to promote R&D, companies would be able to extend their exclusivity periods to a maximum of 12 years if they released their product in all EU member states (+2 years), addressed diseases with an unmet need (+6 months), conducted comparative trials (+6 months), or created drugs that are able to treat multiple diseases (+1 year). For medicines for rare diseases, the standard duration of market exclusivity will be nine years. Additional exclusivity time can be granted if the drug addresses a high unmet medical need (+1 year), is launched in all Member States (+1 year), is a new therapeutic indication for an already authorized orphan medicine (up to 2 years). The regulatory production periods can add up to maximum of 13 years, compared to the maximum of 10 years today.
The rules also would require companies to disclose any research funding received from public authorities or publicly funded organizations on public websites.
In addition to the proposals, the European Commission also proposed a Council Recommendation to work on improvements in the fight against antimicrobial resistance (AMR).
Comments
In the press release announcing the proposals, the Commission stated that “there are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems.” The release also referenced “digital transformation and [adapting to] new technologies” as well as the European Green Deal.
However, Nathalie Moll, Director General at the European Federation of Pharmaceutical Industries and Associations (EFPIA) said that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.” Hubertus von Baumbach, President of EFPIA, echoed Moll’s sentiment, saying “although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk: overall, it weakens the attractiveness for investment in innovation and hampers European science, research, and development.”