Changes in EU pharmaceutical legislation and topical pharmaceutical issues in the EU attracted a wide audience

Participants of the webinar organised by the University Eastern Finland School of Pharmacy and the Research Network for Rational Pharmacotherapy (RATTI) on 10 October 2023 heard about the pharmaceutical issues currently ongoing in the EU and discussed the changes from Finland’s perspective. 

The main proposals for changes to the European pharmaceutical legislation and their objectives, published by the European Commission in April 2023, were discussed at the event. Speeches commenting on the impacts of the reform of pharmaceutical legislation on Finland and globally were given by representatives from Fimea, Pharma Industry Finland, the Finnish Generic Pharmaceutical Association and SOSTE Finnish Federation for Social Affairs and Health. In addition to the reform of the pharmaceutical legislation, the webinar participants were told about the European Health Union and the operation of the Health Emergency Preparedness and Response Authority (HERA). 

The webinar targeted at stakeholders in the pharmaceutical sector, anyone with an interest in EU pharmaceutical issues and students attracted almost 300 listeners online. 

Massive reform will significantly change legislation on medicinal products

Mari Laurén-Häussler, Senior Officer for Legal Affairs from the Ministry of Social Affairs and Health gave an introduction to the discussion by describing the main content of the EU’s pharmaceutical package. The objective of the Commission’s proposal for pharmaceutical legislation is to promote the development of medicines especially with regard to unmet medical needs, ensure affordable pricing and availability of medicines, reduce the environmental impact of medicines, and lighten the administrative processes related to the different stages in the lifecycle of medicines.

The objectives will be promoted through three “As” and three “Cs”:

• Access – Single Market
• Availability – prevention of shortages
• Affordability – ensuring affordable pricing
• Competitiveness – a competitive regulatory framework
• Compliance – environmental sustainability
• Combatting AMR – reducing antimicrobial resistance

The legislative proposal includes a large number of concrete measures to promote these themes. Examples of the measures include speeding up the marketing authorisation process, increasing the scientific advice and other support preceding the marketing authorisation, lightening the administrative burden and tying the incentives for the pharmaceutical industry to the market entry (Access, Competitiveness). The aim is to prevent shortages of medicines (Availability), for example, by improving monitoring and coordination in the EU, extending pharmaceutical companies’ reporting period for shortages from two months to six months, and introducing an obligation to draw up a shortage prevention plan. Affordable pricing (Affordability) is aimed, for example, at increasing the market access of generic products by promoting and encouraging pharmaceutical companies to undertake comparative clinical trials. Environmental sustainability (Compliance) is promoted by including the environmental risk assessment in the marketing authorisation and by extending the environmental risk assessment to products that were granted a marketing authorisation before 2005. Efforts are made to reduce antimicrobial resistance (Combatting AMR) by promoting prudent use of antimicrobials and creating incentives for the development of new antimicrobials.

In Finland, the Government issued a Union communication on the legislative proposal to the Finnish Parliament on 12 October 2023. At the European level, the Commission’s proposal for pharmaceutical legislation will next proceed to an examination by the European Council and the European Parliament. The European Parliament aims to already form its view before next spring's European Parliament elections, whereas it will take longer for the Council to form its position. In any case, the legislative process will take several years. Because it is a directive, it must be further implemented to national legislation after its adoption.

General agreement about the importance of the objectives of the reforming legislation, debate about the means

The impacts of the reform of the EU’s pharmaceutical legislation were commented on by Director Anna Siira from Fimea, Director Nadia Tamminen from Pharma Industry Finland, Executive Director Heikki Bothas from the Finnish Generic Pharmaceutical Association and Senior Specialist Mirjami Tran Minh from SOSTE Finnish Federation for Social Affairs and Health. All the parties considered the reform of the EU pharmaceutical legislation necessary and its objectives important. Everyone also recognised the necessity of specifying the details and clarifying the definitions. It was also noted that the legislative reform will have a significant impact on the operating processes of the European Medicines Agency, the national pharmaceutical authorities and the pharmaceutical industry.

There was most discussion about the measures proposed to promote the availability of medicines. The Commission’s legislative proposal contains a large number of individual measures, but their real impact on the availability of medicines was interpreted as limited. This is largely linked to issues concerning the prices and reimbursability of medicines being the national responsibility of the Member States, and the EU not having competence in them (Access, Affordability). Especially the measures related to incentives for the pharmaceutical industry gave rise to discussion.

The environmental objectives were considered important, while it was also stated that the environmental impact assessment has to be in balance with the public health-related and therapeutic objectives. According to the Commission’s proposal, an inadequate environmental risk assessment could lead to the refusal of the marketing authorisation even if the other conditions for the marketing authorisation were met. This may lead to ethical reflection in a situation where a medicine is important to a group of patients but toxic to the environment. The environmental impact assessment also sets requirements for developing the environmental competence of national pharmaceutical authorities. The introduction of electronic package leaflets was seen as an opportunity to promote the availability and environmental sustainability of medicines, but it was also stated that introducing them to use will be a long process.

European Health Union and HERA promote preparedness for future crises at the European level

Ulla Närhi, National Expert at the EU’s Health Emergency Preparedness and Response Authority HERA, talked about the operation of the European Health Union, established at the time of the pandemic in autumn 2020. Its aim is that the EU Member States and the Commission together prepare for future pandemics and build functioning cooperation models for future crises.

Setting up the European Health Union and its operation have progressed extremely fast and already cover a wide range of different actions, including the extension of the mandates of the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), the Regulation on serious cross-border threats to health, the establishment of HERA, the Pharmaceutical Strategy for Europe, the Proposal for a Regulation on the European Health Data Space, and the Commission’s communications and recommendations on a comprehensive approach to mental health and cancer prevention. 

At the centre of HERA’s operation are the so-called medical countermeasures, i.e. products that can be used for the diagnosis and prevention of all kinds of serious health threats, for protection against them or for the treatment of diseases related to them. For example, they include vaccines, antibiotics, medical devices, diagnostic tests and personal protective equipment. When the operation was launched, three threats with significant impacts were prioritised as the focus areas of HERA’s operation: pathogens with high pandemic potential, CBRN (chemical, biological, radiological and nuclear) threats and AMR (antimicrobial resistance). The operation is divided into a preparedness phase and emergency response.

Discussion and specification are required regarding what in the management of national health crises should be done at the level of the EU and what belongs to the national mandate of the Member States.  Finland's position is that the responsibility for developing preparedness planning and crisis preparedness in health care must remain with the Member States – and that the Commission's actions complement and support them. However, it is advisable to take advantage of the community’s support, for example, in the joint procurement of medical countermeasures, as was learned during the coronavirus pandemic.

Read more:

The European Commission has published its proposal for the reform of pharmaceutical legislation
On 12 April 2023, the European Commission issued its proposal for the reform of pharmaceutical legislation and for measures against the threat of antibiotic resistance. 
The Commission’s press release, a recording of the press briefing and other information material are available on the European Commission’s website   
The Commission’s press releases and other background material   
The European Commission's reform package:
Reform of the EU pharmaceutical legislation

Health Emergency Preparedness and Response Authority (HERA)