The European Commission is preparing the biggest pharmaceutical reform in 20 years. What will change?

The challenges addressed by the reform are fundamental. Medicines authorized for marketing in the EU still do not reach patients fast enough and are not equally available in all member states. There are significant gaps in response to unmet medical needs, rare diseases and antimicrobial resistance. High prices for innovative treatments and drug shortages remain a major concern for patients and health systems. In addition, for the EU to remain an attractive investment destination and a global leader in drug development, it must adapt its regulations to the digital transformation and new technologies, while cutting red tape and simplifying procedures. In addition, new regulations must take into account the environmental impact of drug production in line with the goals of the European Green Deal.

The review includes proposals for a new directive and a new regulation that amend and replace existing pharmaceutical legislation, including regulations on medicines for children and medicines for rare diseases. It aims to achieve the following main objectives:

• Creating a single market for medicines to ensure that all patients across the EU have quick and equal access to safe, effective and affordable medicines;
• Continue to offer an attractive and innovation-friendly framework for drug research, development and manufacturing in Europe;
• Dramatically reduce the administrative burden by significantly speeding up procedures, reducing the time it takes to issue marketing authorizations for drugs so that they reach patients more quickly;
• Increasing accessibility and ensuring that medicines reach patients regardless of their country of residence in the EU;
• Addressing antimicrobial resistance and the presence of pharmaceutical substances in the environment through a "One Health" approach;
• Making medicines more environmentally sustainable.

To achieve these goals, the reform covers the entire life cycle of drugs.

Main elements of the proposal:

• Better access to innovative and affordable medicines for patients and national health systems: new incentives for companies to make medicines available to patients in all EU countries and to develop products to meet unmet medical needs. In addition, earlier availability of generic and biosimilar medicines will be promoted, and the marketing authorization procedure will be simplified. Measures will be introduced for greater transparency in public funding of drug development and incentives for generating comparative clinical data;
• Promoting innovation and competitiveness through an efficient and simplified regulatory framework: the reform will create an innovation-friendly regulatory environment for developing new drugs and repurposing existing drugs. The European Medicines Agency (EMA) will provide better regulatory and scientific support to developers of promising drugs to facilitate rapid approval and help SMEs and nonprofits. There will be an acceleration of scientific evaluation and drug approvals (e.g., EMA approval procedures will take 180 days, which currently average 400 days), and the regulatory burden will be reduced through simplified procedures (e.g., by abolishing marketing authorization renewals in most cases and introducing simpler procedures for generics) and digitization (e.g., electronic submission and electronic product information). The highest standards of quality, safety and efficiency for drug approvals will be maintained;
• Effective incentives for innovation: legal protection for innovative medicines for up to 12 years, combined with existing intellectual property rights, will ensure that Europe remains an attractive center for investment and innovation. To create a single market for medicines, the reform will steer the current system away from one-size-fits-all legal protection toward a more effective innovation incentive framework that also promotes public health interests. To achieve this, a minimum regulatory protection period of eight years is proposed, which can be extended in the following cases: if drugs are marketed in all member states, if they address unmet medical needs, if clinical trials with a control group are conducted, or if a new therapeutic indication is developed. Combining existing intellectual property rights with new legal protection periods will also help secure the EU's competitive advantage in pharmaceutical development, one of the most protected areas in the world. The reform will boost efforts to keep research and development focused on the greatest needs of patients and to ensure that patients have more rapid and equal access to medicines across the EU;
• Addressing drug shortages and ensuring security of supply: the reform introduces new requirements for monitoring drug shortages by national authorities and the EMA, and a greater coordinating role for the EMA. Companies' responsibilities will be strengthened, including earlier reporting of drug shortages and recalls, and developing and maintaining shortage prevention plans. An EU-wide list of critical medicines will be developed and vulnerabilities in the supply chain for these medicines will be assessed, with specific recommendations for measures to be taken by companies and other stakeholders in the supply chain. In addition, the Commission may adopt legally binding measures to enhance the security of supply of certain critical medicines;
• Better environmental protection: better enforcement of current environmental requirements will reduce the potential negative effects of drugs on the environment and public health;
• Reducing antimicrobial resistance: antimicrobial resistance is considered one of the top three health risks in the EU. The reform offers incentives in the form of transferable exclusivity vouchers for companies investing in new antimicrobials that can treat resistant pathogens, addressing current market failures. Measures and targets for the prudent use of antimicrobials, including adjusted packaging and prescribing requirements, will also be introduced to maintain antimicrobial efficacy.

Stepping up EU action to combat antimicrobial resistance as part of a "One Health" approach

Antimicrobial agents are essential medicines. Over the years, however, their excessive and inappropriate use has led to an increase in antimicrobial resistance, which means that antimicrobials are losing their effectiveness and treating infections is becoming more difficult, if not impossible. Today's package therefore also includes a proposal for a Council Recommendation containing complementary measures to combat antimicrobial resistance in the fields of human health, animal health and the environment, through the so-called "One Health" approach.

The proposal supports the prudent use of antimicrobials, recommending specific and measurable targets for reducing their use and promoting a high level of infection prevention, especially in hospitals, and control in the field of human health. The proposal also increases public awareness, education and training of relevant professionals, and promotes cooperation among stakeholders from all relevant sectors.

The recommended targets were developed with the support of the European Center for Disease Prevention and Control (ECDC) and take into account national situations (different levels of antimicrobial consumption, spread of key resistant pathogens in member states). They also enable better monitoring of progress in the coming years.

In addition, the proposal will help strengthen national One Health action plans on antimicrobial resistance, support research and innovation, strengthen surveillance and monitoring of antimicrobial resistance and antimicrobial consumption, strengthen global action, contribute to the development of a multi-country EU financial incentive to improve access to antimicrobials, and encourage the development of other medical countermeasures against antimicrobial resistance, such as vaccines and rapid diagnostics.

Source: press mat.