Pharmaceutical Legislation

[Anita Damelio]

TheCommission has considered the positions and priorities raised by interested parties and the public and has been working closely with Member State authorities in the context of its consultative committees.

The reform of the pharmaceuticals framework also aims to address systemic shortages and ensure security of supply of critical medicinal products, at all times. It was informed by a Structured Dialogue with relevant stakeholders on the security of supply of medicines (launched in June 2021). A study on shortages of medicines (published in June 2021) analysed the root causes of shortages of medicines and analysed the current framework in that respect. It presented a series of 16 policy measures at EU and national level, which were considered in the reform of the pharmaceutical framework.

Access to medicine varies across Europe. Some Europeans have to wait for 4 months on average to find a given medicine in their nearest pharmacy, while others have to wait more than 2 years for the same medicine. There is also growing concern about possible shortages of medicines, such as antibiotics and painkillers.

The European Commission is therefore proposing to modernise the pharmaceutical sector with a patient-centred approach, that also fully supports an innovative and competitive industry. Its approach will preserve the EU's high standards for the authorisation of safe, effective, and quality medicines.

All patients should have the same access to medicine in Europe. Medicine should reach patients when they need it, and all Member States should receive the medicine at the same time. This legislative proposal aims to give a better access to effective and affordable medicines to all.

In practice, this means making sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines. To this end, new incentives encourage companies to make their medicines available to patients in all EU countries, while EU legislation on medicines for children and rare diseases will also be revised.

To better prepare for the winter of 2023/24, the Health Emergency Preparedness and Response Authority and the European Medicines Agency have already identified key antibiotics for which they anticipate the risk of critical shortages ahead of this and future winters.

In the immediate, the Commission launched a European Voluntary Solidarity Mechanism for medicines on 24 October 2023. This allows a Member State to flag their needs for a given medicine to other Member States, that can respond by indicating the medicines available for redistribution.

Beyond the EU, we will establish a network of international partners to address supply chain resilience. We will also set up strategic partnerships with non-EU countries for the production of critical medicines, reflecting both local demands and needs at the EU and global level.

The EU aims to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe. The EU will create this environment by promoting world-class innovation, governed by stable and consistent rules that keep pace with innovation and which increase competitiveness while reducing red tape and costs.

It will seek to ensure faster authorisation of innovative medicines by implementing simpler rules and procedures and through more patient involvement in the medicines assessment processes without compromising safety.

To establish this system, the Commission is proposing a directive that contains all the requirements for authorisation, monitoring, labelling and regulatory protection, placing on the market and other procedures for all medicines authorised at EU level and at national level and harmonises the authorisation rules in the EU.

Antimicrobials are medicines used to prevent and treat infections in humans, animals and plants. Antimicrobial resistance (AMR) occurs when microbes stop responding to medicines designed to kill them, and is caused by overuse or misuse of antimicrobials such as antibiotics.

The European Commission put forward a Council Recommendation on stepping up EU actions to combat AMR to provide solutions for human, animal, and environmental health. The Council adopted the proposed Recommendation on 13 June 2023.

EFPIA is committed to working with all stakeholders to close the competitiveness gap with other regions of the world, while taking action now to create faster, more equitable and sustainable access to medicines.

The EU Pharmaceutical Legislation will shape the future of research, development and manufacturing in Europe for decades to come. Unless changes are made, Europe will become reliant on other regions' medical innovation and our citizens will wait longer for the latest advances in care.

The proposed legislation significantly reduces European intellectual property (IP) rights while adding complex, incompatible and unworkable criteria to recover the lost IP protection. Its impact will accelerate several negative trends:

Include a patient-centred, broad definition of UMN that would incentivise avenues of research to meet the needs of people living with rare diseases and chronic conditions, and appropriately value incremental innovation.

Deliver a robust framework for mechanism of action Paediatric Investigation Plans (PIPs) to ensure that it is effective and manageable for developers, including an additional reward for this increased obligation.

Over the coming months, EFPIA and its members remain committed to working with Members of the European Parliament (MEPs), Member States and other stakeholders to close, rather than widen, the gap between the EU and the US and Asia.

The pharmaceutical industry had been looking forward to the revision of legislation as an opportunity to fix long-standing problems, update a 20-year-old regulatory system and make it fit for purpose for the innovations of the future.

Improving access and availability of medicines requires solutions to be developed in partnership with member countries, not ill-repurposing of the EU legislation that provides the basis for an entire European research and development (R&D) ecosystem for the benefit of its patients.

Any proposal to try to improve access by linking it to incentives such as intellectual property rights in a review of EU legislation aimed at approving or incentivizing medicinal products, will be ineffective and unworkable. While intellectual property rights are the sole responsibility of the innovative company, access to market is not. Making the former dependent on the latter leads us nowhere, except less attractive as a region to do R&D.

First, the entire industry is relying on the EU pharma legislative review delivering just that: a first-class, 21st-century regulatory framework that will help reduce regulatory burden, speed up access and ensure Europe is a globally competitive region for medical innovation.

It takes the EMA 426 days to approve a new active substance, compared to 244 days in the U.S., 306 in Canada, 313 in Japan or 315 in Australia. This means that Europe has become less attractive to developers, with the percentage of global clinical trials being carried out in Europe declining from 29 percent to 25 percent over the past 10 years. Right now, many European patients miss out on the latest innovative treatments that are available in Asia and the U.S.

EFPIA has four proposals for legislative improvement that could take our current framework to the next level. The industry also proposes eight nonlegislative actions that could ensure we improve the competitiveness of our EU regulatory system even before the legislation is revised.

Our request is that while legislators focus the revision of the pharma legislation on the regulatory review to make our region competitive again, we all commit now, to working together to find predictable, practical and timely solutions to improving access to medicines, outside of the review of legislation.

* In April of this year, industry committed to file for pricing and reimbursement approval in all 27 member countries within two years of receiving marketing authorization, where local systems allow, and following that commitment by means of the Access Portal.

The above access actions are supported by a series of other measures, which if taken together will help address inequality of access: Evidence generation; horizon scanning; improved public procurement processes; and the implementation of novel pricing and payment methods, including equity-based tiered pricing reflecting member country ability to pay to help address access, affordability and availability challenges, as well as the correct implementation of the EU Health Technology Assessment regulation.

Incentives will be given to companies which launch medicines in all Member States, develop medicines that address unmet medical needs, conduct comparative clinical trials or develop medicines that can treat other diseases as well (second indications of repurposing).

Given the practical difficulty to identify how indirect public funding instruments (e.g., tax advantages) have supported a particular product, marketing authorization holders will be required to publish a report listing all direct financial support received from any public authority or publicly funded body for the research and development of the medicinal product (clinical trials), whether successful or not.

The reduction of the overall period for marketing authorization procedure from 210 days to 180 days is foreseen. The proposal also aims at optimising the regulatory support (e.g., scientific advice) to SMEs (small-medium enterprises) and non-commercial organisations, resulting in additional reductions of administrative costs for these parties. According to the proposed Regulation, scientific advice from EMA is also provided for any legal or natural person developing a medicinal product intended for paediatric use.

According to the Preamble of the proposal for the new Directive, the Marketing authorization applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment (ERA) or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorization should be refused.

3a8082e126