On April 26, 2023, the European Commission brought out the proposed new EU pharmaceutical legislation, the most significant reform in two decades.
This revision was strongly desired to improve availability and accessibility, also in economic terms, of medicines, supporting innovation and environmental protection vital today. In addition to the reform, the European Commission also presented a proposal inherent in antimicrobial resistance, a problem against which the fight must be intensified.
Among the various issues currently facing the health system, which will change with the implementation of the new reform, are certainly unmet medical needs, high prices for innovative treatments, and delays, if not shortages, in the supply of medicines. The bureaucracy also needs a turnaround, speeding up and simplifying procedures by moving toward greater digital transformation and opening up to new technologies. Environmental impact, not least in importance, needs to be greatly reduced so the production of medicines will need to be in line with the goals of the European Green Deal.
Having shed some light on what the current problems are, let’s look in detail at what are the main goals the revision aims to achieve:
- Ensure timely and equitable access to safe, effective and affordable medicines for all patients across the EU by creating a single European market
- Invest in innovation for research, development and production of medicines in Europe
- Reduce administrative burdens by streamlining bureaucracy and speeding up the licensing of medicines so they reach patients quickly
- Improving the availability of medicines in every European country without distinction
- Combat antimicrobial resistance
- Improving the environmental impact that medicines have on our planet.
In order to successfully achieve all these goals, the reform covers the entire lifecycle of medicines and provides important new incentives to encourage companies to make their medicines available to patients in all EU countries, seeking to meet all medical needs. Distribution of generic and biosimilar medicines will also be facilitated to meet different economic needs, and measures to increase transparency of public funding for pharmaceutical development will also be introduced.
On the innovation front, the reform will be no less, creating a regulatory environment conducive to the development of new medicines and the repositioning of existing ones.
The European Medicines Agency (EMA) will provide better regulatory and scientific support to research and development departments; scientific evaluations and authorization by the EMA will be accelerated, and the highest standards of quality, safety, and efficacy for the authorization of medicines will be maintained at all times.
Shortages in medicines and security of supply will be addressed by establishing an EU list of critical medicines and updating shortage prevention plans. Better prescriptions will be implemented to limit the negative consequences of medicines on the environment and public health.
A key chapter in the new reform is on antimicrobial resistance, which will be addressed through a “One Health” approach involving human health, animal health, and environmental health. The proposal advocates prudent and moderate use of antimicrobials by promoting high levels of infection prevention; public awareness, education, and training of professionals in antibiotic use will also be encouraged.
The proposed revision of the current pharmaceutical legislation is ambitious, and puts in place a strategy in response to the challenges currently facing the pharmaceutical sector in the European Union.