BELGIUM — The European Federation of Pharmaceutical Industries and Associations (EFPIA), based in Brussels, has urged the European Commission to conduct a thorough assessment of the impact of its upcoming rewrite of the pharma legislation, which was drafted more than 20 years ago.
EFPIA has been opposed to the changes from the outset, estimating that the rewritten legislation could cost the industry €640 million (US$688 million).
According to leaked reports, the proposed changes aim to create a level playing field for accessing new medicines across member states, among other reforms.
This would include the requirement for companies to introduce their drugs evenly throughout the EU, ensuring that countries such as Romania have the same access as Germany or France.
Failure to do so would result in a loss of two of the ten years of exclusivity currently enjoyed by companies, with exclusivity only being restored if the drug is launched in all EU countries. An official proposal is expected on March 29.
According to a statement release, Nathalie Moll, the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), welcomed last week’s Communication on Long-term Competitiveness of the EU.
However, she expressed deep concern that a complete competitiveness check has not yet been carried out to assess the real impact that the pharmaceutical legislation proposals will have on access to the latest treatments, jobs, R&D investment, academia, manufacturing, and growth across Europe.
Modeling by Charles Rivers Associates, funded by EFPIA, indicates that the rewrite could result in approximately €14 billion (US$15 billion) in lost biopharma R&D investments per year.
Earlier this month, Novo Nordisk CEO Lars Jorgensen reportedly told Reuters that Europe would lose out to the U.S. and Japan for new R&D investments with the rewritten legislation.
Similarly, in January, Stefan Oelrich, head of Bayer’s drugs business, told the Financial Times that Europe was becoming “innovation unfriendly” and that their company was shifting its commercial footprint and the resourcing of their commercial footprint away from Europe.
According to an EFPIA spokesperson who spoke to Endpoints News, “By 2040, China will have relegated Europe to third place as a destination for company life science investment. A set of proposals designed to save Europe millions are going to cost Europe billions.”
Currently, the European Commission’s efforts to revise medical product-related regulations are not impressive as the implementation of reformed medical device regulations has been postponed to 2028 for certain devices due to supply shortages, despite being officially applicable since May 2021.
However, Europe is not alone in seeking to improve its pharmaceutical industry. The United States and the United Kingdom also have proposals and laws in different stages of implementation to reduce the cost and prices of drugs through negotiations and price-setting, as well as to enhance their markets’ appeal for clinical trials.
At the same time, the UK’s MHRA unveiled a series of plans to expedite approval and conduct clinical trials on the island.
For instance, the plans involve merging regulatory and ethical reviews of clinical trial applications, potentially halving study approval times and reducing the duration from application to enrolling the first patient by 40 days, according to the MHRA.
The new pharmaceutical legislation proposed by the EC is expected to provide benefits to the industry, such as expediting product development and authorizations in areas of unmet need and creating new incentives for antimicrobial development.
Additionally, the legislation aims to reduce administrative burdens and future-proof the industry. The legislation will also allow for regulatory flexibility by utilizing real-world data and artificial intelligence for evidence generation and the ability to adjust decisions based on new evidence.
Meanwhile, big Pharma executives continue to express unease with the UK’s “Voluntary scheme for branded medicines pricing and access” (VPAS), which places the burden of keeping certain medication prices affordable on the companies.
The VPAS agreement is set to expire at the end of 2023, and pharma companies with branded medicines under the voluntary agreement will have to return almost £3.3 billion (US$4.1 billion) in sales revenue to the government.
AbbVie and Eli Lilly have already left the pricing agreement after the announcement of the revenue return.
The Association of the British Pharmaceutical Industry (ABPI) is working on new proposals for a revised agreement, which will be published later this year.
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