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EU Lawmakers Agree on Pharmaceutical Data Rules Overhaul

 |  March 19, 2024

European Union lawmakers have forged a compromise on the extensive overhaul of EU pharmaceutical regulations, aiming to address concerns raised by the pharmaceutical industry while pushing forward essential reforms.

The compromise, as revealed in a parliamentary proposal, indicates progress in accommodating the pharmaceutical industry’s apprehensions regarding the exclusivity period for new medicines. Notably, this compromise comes after months of deliberation and negotiation among EU lawmakers.

The proposed legislation, introduced by the European Commission in April the previous year, aims to streamline the approval process for new medicines, incentivize the development of medications targeting antibiotic-resistant bacteria, enhance patient access, and adapt regulations to embrace technological advancements such as artificial intelligence.

However, the pharmaceutical industry, represented by the Brussels-based industry group EFPIA, has expressed reservations about the proposed reforms. EFPIA has warned that the changes risk exacerbating the decline in innovation and research within the continent, which has already witnessed a 25% downturn. Central to the industry’s concerns is the linkage of a medicine’s exclusivity period to its availability across all 27 member states, where approval timelines can significantly differ.

In the draft compromise viewed by Reuters, committee members have proposed raising the baseline data protection period to 7.5 years. An additional year of incentives would be granted if the medication addresses “unmet medical needs” and if clinical trials are conducted within the EU. Moreover, a company would enjoy three years of protection against generic competition, extending the total exclusivity period to a maximum of 11.5 years, a slight reduction from the Commission’s proposed 12 years.

Additionally, the responsibility for launching a new medicine would shift to member states, requiring them to initiate the process by requesting the medication, rather than obligating companies to navigate the approval process across all 27 countries simultaneously.

Regarding orphan diseases, where the potential for profitability is significantly lower for pharmaceutical companies, the baseline exclusivity period would remain at nine years, with the possibility of extending to 11 years if the medicine addresses unmet medical needs.

To ensure the legislation remains relevant amidst technological advancements, the proposal includes a “regulatory sandbox” as suggested by the Commission, with added safeguards. This sandbox is designed to provide a structured environment for experimentation, particularly concerning digitalization, artificial intelligence, and machine learning applications in the pharmaceutical domain.

Source: CA News Yahoo