The EC proposes the biggest pharmaceutical reform
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Council Recommendation to fight against AMR
April 27, 2023
Yesterday, 26th of April, the European Commission released a statement to communicate a very important reform to the current pharmaceutical legislation. The main goal is to “make medicines more available, accessible and affordable” as well as to boost the European pharmaceutical industry. Another relevant part of this revision is a Council recommendation to fight Antimicrobial Resistance (AMR).
At a European level, according to the European Commission, these are the main challenges that this revision wants to tackle, regarding health and medicines:
- Medicines authorised in the EU don’t reach patients quickly enough
- Significant gaps when dealing with unmet medical needs
- Rare diseases
- Innovative treatments being too expensive
- Shortages of medicines
- A necessary common effort towards digital transformation
- Environmental negative effects on the medicine production
- Antimicrobial resistance (AMR)
The European Union counts on a pharmaceutical legislation that already addresses these issues, but the European Commission is planning a reform, “the largest in 20 years”. This way, the EC aims at facing these problems by transforming the pharmaceutical sector into one “more agile, flexible and adapted to the needs of citizens and businesses across the EU”. Also, this way, this institution wants to boost innovation, competitiveness and attractiveness to the to the European pharmaceutical industry.
What are the specific goals of this reform?
According to the official release, there are several specific goals to reach with the reform of the pharmaceutical legislation:
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
- Reduce drastically the administrative burden by speeding up procedures significantly, reducing authorisation times for medicines, so they reach patients faster;
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
- Make medicines more environmentally sustainable.
How will they be achieved?
The key of this proposal lays on several vital pillars in order to achieve the proposed goals and face the different challenges. Better access to innovative and affordable medicines for patients and national health systems is the first one, as new incentives will encourage companies to make their medicines available to patients in all EU countries and develop products that address unmet medical needs. The second one is promoting innovation and competitiveness through an efficient and simplified regulatory framework: the reform will create an innovation-friendly regulatory environment for the development of new medicines and the repurposing of existing ones.
Effective incentives for innovation is the third one, with regulatory protection of up to a maximum of 12 years for innovative medicines, combined with the existing intellectual property rights, will ensure Europe remains an attractive hub for investment and innovation. Also, addressing shortages of medicines and ensuring security of supply by introducing new requirements for monitoring of shortages of medicines by national authorities and EMA and a stronger coordination role for EMA. Obligations on companies will be strengthened, including earlier reporting of shortages and withdrawals of medicines and development and maintenance of shortage prevention plans. Es the environmental protection is one of the main reasons of this reform, better enforcement of current environmental requirements will limit the potential negative consequences of medicines on the environment and public health.
This reform as well as the proposal for council recommendation to tackle Antimicrobial Resistance come in a post COVID-19 moment and in a time when environmental measures as well as AMR solutions are much needed. If you want more information, here is the whole European Commission press release.
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[…] pharmaceutical legislation, with several goals and challenges to be addressed, as we told you in this post. This revision is a very ambitious one, the biggest in 20 years, and seeks to “make medicines […]