By Mark Buckingham, recall advisor
Reports indicate that the European Commission’s proposed overhaul of the EU’s general legislation on medicines for human use was rejected by the Regulatory Scrutiny Board, sending it back to the Commission for revision.
The Commission was originally slated to adopt the proposed changes to the law in the fourth quarter of 2022, but this latest development may push adoption to at least the first quarter of 2023. The overhaul was initially launched in 2021 by the Commission in order “to ensure a future-proof and crisis-resistant medicines regulatory system.”
With this revision, the Commission seeks to ensure affordable access to medicines in all Member States; foster innovation, as part of a goal across sectors to make the EU a centre for innovation; improve security of supply; and integrate new scientific and technological developments.
One of the provisions that is reportedly delaying the proposal relates to market exclusivity. Current rules allow pharmaceutical companies to have market exclusivity over new medicines for 10 years, but the draft proposal would cut that exclusivity to eight years with the goal of making medicines more affordable.
Under the new proposed rules, businesses who launch their medicines in all 27 EU markets within two years of regulatory approval can receive the current 10 years of market exclusivity. But some in the pharmaceutical industry have argued this provision may not promote the intended goal of increasing innovation.
Groups like the European Federation of Pharmaceutical Industries and Associations (EFPIA) have said that this provision “would represent a further erosion of existing [intellectual property] protecting medical innovation in Europe.”
The EU continues to trail other countries, like the U.S. and Japan, in pharmaceutical research and development despite growth in new drug exports. Any regulation that may have the potential to impact the EU’s competitiveness in pharmaceutical innovation will likely run into approval problems. In addition, innovation can introduce new challenges for product safety if new formulas, ingredients, or processes are introduced. This means more risks for companies launching products that lack years of in-market use and testing.
Other key parts of the draft proposal still need to be fleshed out, including the definition of what exactly launching a drug on the market entails. Still, it’s likely that the EU will see a final draft version of the Commission’s proposed legislative overhaul sometime before mid-2023.
Businesses in the pharmaceutical sector should keep a close eye on news related to the proposed legislation and carefully review any public comments from influential industry groups that may have an impact on the final version.
Once the proposal is released, businesses should begin engaging with third-party experts and reviewing their processes to see how the provision discussed in this blog, and the rest of the legislation, would impact their business.
Trusted by the world’s leading brands, Sedgwick has managed more than 5,000 of the most time-critical and sensitive product recalls in 60+ countries and 50+ languages, over 25 years. To find out more about our experience within the pharmaceutical sector, visit sedgwick.com/brandprotection/industries/pharmaceutical