A year of many legislative changes for Fimea and operators
The EU Clinical Trials Regulation entered into force in 2014 and took effect on 31 January 2022. The EU Veterinary Medicines Regulation took effect only a few days earlier, on 28 January 2022, following a three-year transition period. In the beginning of April, a large number of amendments to the Medicines Act entered into force along with complementary regulatory amendments.
EU competitive for the conduct of clinical trials
The aim of the Clinical Trials Regulation is to improve the competitiveness of European clinical research by harmonising practices in the Member States and to facilitate the functioning of the authorisation procedure.
With the application of the Regulation, the Clinical Trials Information System (CTIS), maintained by the European Medicines Agency EMA, was introduced. It allows one submission to all Member States concerned by a given trial. The Regulation provided for a transition period of 1 year for the implementation of the system, and as of 31 January 2023, all new applications must be submitted through the system. In April 2022, Fimea received the first trial application in compliance with the EU Regulation through the EU portal.
The national Act on Clinical Trials on Medicinal Products (983/2021) came into effect at the same time as the Regulation. It supplemented the Regulation in the use of the national leeway provided by the Regulation.
Together with TUKIJA, Fimea prepared a draft for a national decree on fees related to clinical drug trials which the Ministry of Social Affairs and Health put out to consultation in December 2021. The Decree on fees chargeable by the Finnish Medicines Agency entered into force on 2 February 2022.
Veterinary Medicines Regulation helps to combat antimicrobial resistance
The EU Veterinary Medicines Regulation, which took effect at the beginning of 2022, is directly binding on all operators. The Commission is preparing supplementary regulations, some of which have already been completed while others are still under preparation. These will also be binding on all Member States.
The Veterinary Medicines Regulation also requires amending the national laws. The Ministry of Social Affairs and Health was preparing these amendments, but a government proposal was not put forward during the session, and its preparation was carried over to the next parliamentary session. Fimea’s updated regulations will be finalised and put out to consultation after the amendments to the Medicines Act enter into force.
The Veterinary Medicines Regulation aims to ensure the highest level of public and animal health and environmental protection. One of the key objectives is to combat antimicrobial resistance in the entire EU through minimal and responsible use of antibiotics. The Veterinary Medicines Regulation harmonises the measures binding on all Member States.
The Regulation sets out to reduce the administrative burden, enhance the internal market and increase the availability of veterinary medicinal products. The practical means to reach these goals include harmonising the authorisation of veterinary medicinal products, building common databases and clarifying pharmacovigilance measures.
Price competition now possible for OTC products
At the beginning of April, with the amendments to the Medicines Act and the supplementary regulation amendments, a historic change took place: price competition for over-the-counter drugs was allowed. The regulation amendments also affect the establishment of pharmacies, pharmacy licence notices and application for a pharmacy licence, change of the pharmacy owner as well as online pharmacy services and pick-up boxes, for example.
Allowing price competition for OTCs means that they have a minimum and maximum price based on pharmaceutical tariffs, but each pharmacy can individually set the price between these two extremes. Price competition may lower the price citizens pay for OTC products.
This also means changes to Fimea's supervisory tasks. Previously, supervision focused on marketing authorisation holders and the content of marketing. Now, it also focuses on the retail prices of medicinal products and notification of these prices. Fimea conducts supervision in close cooperation with the Finnish Competition and Consumer Authority (FCCA).
Supervision of clinical drug trials (on the Fimea website)
EU Veterinary Medicines Regulation becomes effective on 28 January 2022 – national regulations currently under preparation (Fimea.fi-news 17.12.2021)