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EU pharmaceutical legislation reform: the importance of transparency and cooperation.

In April 2023, the European Commission published the proposed reforms of the general pharmaceutical legislation. Their overarching aim is to make access to medicines more resilient, fair, and competitive, and are structured according to five key objectives: affordability of medicines, supply of medicines, competition and incentives, environmental sustainability and fighting AMR. Each in turn raises concerns and interest for different stakeholders. We discuss the proposed changes across a two-part series, starting with the affordability and supply of medicines and finishing with competition and incentives.

Affordability of medicines

Whether medicines are funded by patients or healthcare systems, affordability is a persistent and widespread concern. The new EU General Pharmaceutical Legislation aims to make medicines more affordable namely thought transparency and cooperation.

What does this mean for pharmaceutical companies? Following the implementation of the legislation, pharmaceutical companies will now be required to publish information on any direct public financial funding they have received for the support of research and development of medicines. Improving transparency on funding is expected to aid reimbursement negotiations and make medicines more affordable. Companies will also be incentivised to generate comparative clinical data to further strengthen decision making. However, within the literature there are also concerns that greater transparency could impact the flow of new medicines by increasing administrative costs. Incentivising comparative clinical data could also cause commercial rivalry as research based pharmaceutical companies—more adept at providing data—are likely to be favoured.

At a country-level, the Commission proposes non-legislative action for cooperation between member states on relevant pricing and reimbursement policies. Since cooperative action is proposed at a non-legislative level, there may be some concern among patient organisations and funding bodies that this will not occur or translate into changes in pricing and reimbursement policies. However, the Commission has also promoted the use of joint procurement of medicines as a successful way to improve cooperation between member states, citing COVID-19 therapeutics and monkeypox vaccines as success stories.

Supply of medicines

As part of the reforms, the Commission has drawn attention to medicine shortages. To pre-empt challenges, the new legislation proposes coordination and transparency at a national and EU level.

Relevant authorities will be required to monitor shortages and companies will need to develop shortage prevention plans and maintain contingency stocks. The European Medicines Authority (EMA) will be given more power to coordinate and monitor critical medicines and will be required to draw up a list of medicines that are considered critical in the EU health systems. For medicines that are identified, recommendations will be made to improve the security of supply. To meet these reforms, companies and relevant authorities will face a large upfront—although mostly administrative—burden.

Will transparency from companies and cooperation between member states translate into change?

These reforms focus on providing patients with better access and making medicines more affordable for the healthcare system. If successful, the proposed first steps to alleviating the financial burden could result in significant implications for future pricing and reimbursement decisions. In turn, these steps may make it easier for companies to roll out medicines across all member states, alleviating concerns raised by potential changes to the regulatory protection period (and addressed in our second article). However, as we have highlighted, the changes will impose a significant administrative burden on industry and will require significant cooperation between national bodies.

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