🔶The European Commission has unveiled draft legislation that addresses the planned reform of EU pharmaceutical law. This is the biggest revision of pharmaceutical law at EU level in 20 years.
🔶The main reason for reforming this area of law in the European Union is the need to ensure equal access to safe and affordable medicines wherever you live in the EU and to reduce the environmental impact of medicines. The changes also respond to the need to create a more innovative and competitive environment for the development and production of medicines and innovative treatments in Europe.
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➤The reasons for the new regulations also include other shortcomings in pharmaceutical legislation:
Patients' medical needs are not sufficiently met.
Affordability of medicines is a challenge for healthcare systems.
Patients in the EU have unequal access to medicinal products.
Shortages of medicinal products are becoming an increasingly serious problem in the EU.
The life cycle of a medicinal product can have a negative impact on the environment.
The regulatory framework does not take sufficient account of innovation and in some cases creates unnecessary administrative burdens.
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➤REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26.04.2023. laying down EU procedures for the authorisation and supervision of medicinal products for human use and laying down the rules governing the activities of the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 - as this document is referred to - highlights that EU pharmaceutical legislation has enabled the authorisation of safe, effective, high-quality medicinal products. However, patient access to medicinal products in the EU and the safety of the supply are of increasing concern.
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➤The document outlines the overall objectives of the changes such as:
to guarantee a high level of public health by ensuring the quality, safety and efficacy of medicinal products for EU patients;
to harmonise the internal market for the supervision and control of medicinal products and the rights and obligations of Member States' competent authorities.
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➤And specific objectives:
Ensure timely and equitable access to safe, effective and affordable medicines for all patients across the EU;
to improve security of supply and ensure that patients have access to medicines wherever they live in the EU;
to create an attractive, innovation-friendly and competitive environment for research, development and manufacturing of medicines in Europe;
to make medicines more environmentally sustainable.
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➤Key further plans at EU level :
Establish an EU list of critical medicines to identify which medicines require additional measures in the supply chain.
Introduce common derogations in 2024 so that medicines reach patients.
Organise an exchange of best practices on mutual pricing and reimbursement levels between EU countries.
Issue EU guidelines on importing medicines to increase security of supply by early 2024 at the latest.
Initiate joint EU purchases of antibiotics and medicines for respiratory viruses for the winter season 2024/25.
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➤Key changes following the amendment:
1. Ensuring drug safety - managing drug shortages in the EU.
All patients in Europe should have equal access to medicines. Medicines should reach where there is demand for them. All countries in the Union should receive medicines at the same time. In practice, this means that all patients in the EU will have equal access to safe, effective and affordable medicines that are available on time.
The European Commission has prepared tools to address the shortage of medicines in the EU. The institution responsible for managing this issue will be the European Medicines Agency, which will be given more competences and tools under the reform. Pharmaceutical companies will have to inform the EMA in good time about shortages of medicinal products and create their own strategies to address drug shortages. Manufacturers will also be responsible for taking action to reduce critical shortages of specific products and will be obliged to report the results of their actions to the EMA. The EMA will also create an EU list of medicines considered to be the most critical for health systems in the European Union.
In addition, the possibility of obtaining a temporary marketing authorisation for a medicinal product in a state of emergency at EU level in the event of a public health emergency is foreseen.
2. Better access to innovative and affordable medicines for patients.
The EU is introducing new incentives for companies to make medicines available to patients in all EU countries and to develop products to address unmet medical needs. Earlier availability of generic and biosimilar medicines will be promoted. The marketing authorisation procedure will be simplified. Measures for greater transparency in public funding of drug development and incentives for the generation of comparative clinical data will be introduced.
3. Promoting innovation and competitiveness through an effective and simplified regulatory framework
The reform will create innovation-friendly regulation for the development of new medicines and the repurposing of existing medicines. The European Medicines Agency (EMA) will provide better regulatory and scientific support to developers of promising medicines to facilitate rapid approval. There will be an acceleration of the scientific assessment and authorisation of medicines (e.g. EMA authorisation procedures will take 180 days, which currently average 400 days). The regulatory burden will be reduced through simplified procedures - the abolition of marketing authorisation renewals in most cases and the introduction of simpler procedures for generic medicines, and digitalisation - electronic submission and electronic product information. The highest standards of quality, safety and efficacy for the authorisation of medicines will of course be maintained.
4. Longer protection periods
The Commission has proposed to reduce the basic data protection period from eight to six years. Instead, it will be possible to extend this period if a number of additional conditions are met:
by 24 months - if the medicine is launched in all EU countries where a marketing authorisation is valid (and additional conditions to meet patients' needs are met),
by 6 months - if the medicine addresses an unmet health need or contains a new active substance (and comparative clinical trials are conducted),
by 12 months - if a new therapeutic action is indicated, during the data protection period, showing significant clinical benefit compared to existing therapies, and this extension can be used once.
Other (longer) periods of data exclusivity will apply for orphan drugs; it is also envisaged to introduce a short period of data exclusivity for a repurposed medicine, i.e. when a completely new indication is registered for a medicine previously authorised and used in the European Union.
5. Emphasis on environmental protection
Better enforcement of current environmental requirements will reduce the potential negative effects of medicines on the environment and public health;
6. Reduction of antimicrobial resistance
Antimicrobial resistance is recognised as one of the top three health threats 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 adapted packaging and prescribing requirements, will also be introduced to maintain antimicrobial efficacy. All these recommendations - at both national and EU level - aim to reduce antibiotic use by 20% by 2030.