Sustainable well-being through safe and effective medicines and medicinal products

Water treatment plant.
© GettyImages/Bim

Fimea's role in achieving the UN Sustainable Development Goal

Fimea ensures the availability of safe and effective medicines and medicinal products on the Finnish and European markets. Fimea actively influences the EU's pharmaceutical policy and pharmacovigilance and steers innovation activities in the pharmaceutical and health sectors. The goal is to promote the health and well-being of the population in a sustainable manner.

Actions to promote the goal

Fimea is responsible for monitoring the safety, efficiency and quality of medicines throughout their life cycle. Fimea is responsible for assessing marketing authorisations for human and veterinary medicinal products and vaccines as part of the European Heads of Medicines Agencies network. To ensure pharmacovigilance, Fimea participates in Europe-wide safety monitoring of medicines and in the development of global testing and inspection activities. The supervision of clinical trials and medical device clinical trials, the monitoring of the advertising of medicinal products and medical devices and the provision of reliable information are essential in ensuring safe and effective medicines and medical devices. Fimea participates in the European cooperation network to ensure the good quality of blood products and tissue and organ transplants. Fimea also designates and supervises notified bodies for medical devices that issue certificates of conformity to medical devices.

For its part, Fimea is responsible for the comprehensive selection of medicines required by health care. The marketing authorisation assessment, the classification, the safety monitoring and the quality assurance of cheaper products, such as generic medicines and biosimilars, contribute to ensuring economically sustainable access to medicines and health benefits for the widest possible population.

As part of the UN Sustainable Development Goals, Fimea contributes to the marketing authorisation assessment, product classification, safety monitoring and quality and availability assurance of medicinal products, drug replacement therapy and nicotine products required for sexual and reproductive health (such as contraception and treatment of infertility and sexually transmitted diseases).

In terms of the environment and food production, sustainability requires the correct and safe handling of medicinal substances, chemicals and pharmaceutical waste. Medicinal substances are released to the environment through, for example, the use of a medicine or through households due to the incorrect disposal of medicines that have expired or have not been used in. In the environment, medicinal substances can have direct effects on water bodies and wildlife. Antibiotics released to the environment can increase antibiotic resistance, which is a global threat to human and animal health. One of Fimea's duties is carrying out Environmental Risk Assessments (ERA) related to the marketing authorisation for medicines and to cooperate with other assessors carrying out ERA assessments in the EU. The agency also participates in the activities of the European Commission's Pharmaceutical Committee's environment working group. Pharmaceutical waste is also generated in pharmaceutical production facilities, pharmaceutical wholesalers, hospitals, dispensaries, pharmacies, social welfare and health care institutions, animal production facilities and veterinary centres. Fimea supervises the waste processing of pharmaceutical production facilities, pharmacies and hospital pharmacies. Supervision ensures that pharmaceutical waste is not mixed with the medicines that are being sold and that the pharmaceutical waste is disposed of appropriately. Fimea is responsible for monitoring animal consumption of antibiotics, and guidance and monitoring can be directed correctly based on the results. Fimea, the Finnish Food Authority and the University of Helsinki monitor antibiotic resistance in the FINRES-Vet programme and compile joint reports on animal consumption of antibiotics and the susceptibility of bacteria isolated from animals.

Guaranteeing a healthy life and sustainable well-being for people of all ages requires scientific research on medicines and medicinal products, guiding actors in their development projects and encouraging innovation that produces health benefits at the population level. Fimea provides guidance on promoting innovation activities to actors in the sector. Fimea participates in the work of the EU Innovation Network and aims to support the success of both national projects and foreign research investments in Finland. Fimea also advises academic research groups on issues related to regulatory processes and clinical trials. With regard to the UN Sustainable Development Goals, Fimea will pay particular attention to supporting environmentally friendly packaging and innovations aimed at reducing packaging waste and, in accordance with the OECD goal, reducing the animal experiments needed in the development of medicines. In its monitoring activities, the agency aims to promote the introduction of alternative testing and research methods to animal experiments.