3.4 By 2030, reduce premature deaths from non-communicable diseases by one third through prevention and treatment, and promote mental health and well-being.
3.8 Achieve universal health care coverage, including financial risk protection, access to high-quality and essential health-care services, and safe, effective, high-quality and affordable essential medicines and vaccines for all.
Challenge
The United Nations (UN) has set mortality from cardiovascular diseases, cancers, diabetes and respiratory diseases as one of the indicators of healthy life and well-being. The World Health Organisation (WHO) has also published an action programme for the prevention of non-communicable diseases for 2013–2020. The programme aims to reduce premature mortality from non-communicable diseases by 25% by 2025. For example, cardiovascular diseases, diabetes, asthma and allergies as well as cancer are considered chronic, i.e. long-term, and endemic non-communicable diseases in Finland. However, there are effective medicines for these diseases.
Source: WHO.
Shortages of medicines, however, are a globally growing phenomenon. Even small market areas such as Finland regularly face challenges in the availability of medicines. The number of shortages reported to Fimea has increased over the past ten years. Some of the shortages are due to factors that can be influenced to a very limited extent from Finland, such as the globalisation of pharmaceutical and raw material manufacturing and complex pharmaceutical chains. Shortages may be due to production or logistics problems, shortages of raw materials, unexpected fluctuations in demand or commercial reasons.
It is the sustainability of the marketing authorisation holder of the medicine, i.e. the pharmaceutical company, to ensure that the authorised product is continuously available to wholesalers and pharmacies for the needs of patients and other users. This is also a legal condition attached to the granting of a marketing authorisation.
In most cases, breaks in the availability of medicines are not visible to the patient, as a similar product within the scope of generic substitution that can be supplied by the pharmacy is often available.
Fimea’s role
The evaluation of medicines and ensuring that they are manufactured and distributed appropriately is Fimea’s basic task, which we supervise and promote in many different ways. Fimea grants marketing authorisations for human and veterinary medicines both as a national authority and in cooperation with other EU pharmaceutical authorities. Fimea’s basic duties also include supervising the compliance of medical devices and operators in the sector in Finland. A sufficient range of marketing-authorised medicinal products and medical devices, good pharmaceutical manufacturing and distribution practices (Good Manufacturing Practice, GMP and Good Distribution Practices, GDP), well-functioning distribution and a comprehensive pharmacy network are essential to availability. Fimea’s duty is to ensure the sufficiency of pharmacy services, the security of the supply and distribution of medicines and the functioning of price competition in order to safeguard the consumer’s interests.
Fimea actively influences the EU’s pharmaceutical strategy and supervision. Impactful supervision ensures the safety and quality of medicines and the appropriateness of distribution and deliveries. Appropriately targeted, efficient and impactful supervision of pharmaceutical services and medical device operators is the basis for ensuring patient safety and human and animal well-being.
Fimea’s goals
Fimea’s goal is to promote the health and well-being of the population in a sustainable manner. Fimea ensures that safe, efficient, high-quality and affordable essential medicines and vaccinations are available to citizens.
Fimea aims to be the primary and up-to-date source of information on shortages. Fimea’s goal is that shortages of medicines and medicinal products would have a minimum impact on patient care at the national level.
How the achievement of the goals is assessed
Fimea’s has promoted the achievement of the goals in ways including:
Evaluating and granting marketing authorisations for medicinal products for human and veterinary use. The number of evaluations carried out by Fimea as the responsible rapporteur or co-rapporteur country in the centralised authorisation procedure coordinated by EMA has reached a permanently high level, which increases Fimea’s international impact. In addition:
encouraging the development of medicines for children through legislation, thereby improving access to paediatric medicines;
ensuring the availability of medicinal products needed for sexual and reproductive health (such as contraception, treatment of infertility and sexually transmitted diseases), which also promotes gender equality and non-discrimination.
Proportion of human and veterinary medicines in marketing authorisations
Supervising the compliance of medicinal products and operators in the sector. The supervision of the regulatory compliance of devices pertains to medical devices placed on the market as well as their professional use and maintenance. Fimea grants medical devices sales certificates of free sale, research permits and exemptions.
The goal for 2023 is to develop a suitable indicator for responding to the availability of medical devices.
Issuing licences for pharmacies, national pharmaceutical factories and pharmaceutical distributors and by carrying out regular inspections of operators. Fimea also grants licences for blood and tissue establishments and is responsible for regular inspections of the establishments. Fimea monitors the number of inspections in different sectors on an annual basis, ensuring that each sector is adequately supervised.
Ensuring that the Finnish pharmacy network is sufficiently comprehensive: the pharmacy network evolves according to customer needs and medicines are well available also in remote areas. The number of operators in pharmacy services is restricted. Pharmacies will contribute to the development of new service forms, such as online pharmacy services and home delivery services, which promote the availability of medicines. Fimea annually assesses the coverage of the distribution network and monitors the number of pharmacy outlets per inhabitant.
Contributing to maintaining a comprehensive range of medicines needed by health care and maintaining a list of interchangeable medicines. Fimea monitors the number of marketing authorisations granted and the pricing policy of medicines. Products with lower prices, such as generic medicines and biosimilars, enable the availability of economically sustainable medicines and health benefits for the widest possible population. In April 2022, Fimea participated in a legislative amendment enabling OTC medicine price competition. Thanks to the price competition enabled by the legislative amendment, citizens can get OTC medicines at a lower price than before.
Monitoring and, if necessary, investigating shortages with pharmaceutical companies. Fimea maintains a list of current shortages on its website. The list is based on information provided by pharmaceutical companies. The pharmaceutical company is responsible for the information on the availability of the medicine and for its introduction to the market. Fimea’s goal in 2023 is to develop reporting on shortages in currently available medicinal products.
Case example: Fimea works with the European Medicines Agency to reduce shortages
Fimea actively works in the availability management networks of medicines of the European Medicines Agency (EMA). EMA’s working group of designated national contact points for shortages became operational in 2022. Fimea’s long-term work to reduce disruptions in the availability of medicines also continued in the working group that implements the common strategy of EU authorities. Fimea leads one subproject of the EU cooperative project, and this work will continue in 2023. The aim of the subproject is to prevent and reduce disruptions in availability and prevent their impact on patients. The project is closely intertwined with the strategy work of the EU medicines authorities concerning the availability management of medicines and the operation and goals of the working group for national contact points. The aim is to harmonise availability management of medicines among medicines authorities to minimise the impact of availability disruptions on patient treatment at a national level.
By supervising the mandatory reserve medical supplies, the purpose of which is to ensure the availability of medicines in situations where the normal availability of medicines to our country has become more difficult or is prevented due to disruptions in the supply of medicines, a serious crisis or a similar reason. If necessary, Fimea may grant or propose that the Ministry of Social Affairs and Health grants exemptions for pharmaceutical companies to maintain lower or no stocks of mandatory reserve medical supplies in order to secure the uninterrupted distribution of medicinal products.
To ensure that pharmacotherapy is not interrupted, Fimea may grant special permits or exemptions for the release of medicinal products for consumption in situations where a critical medicinal product with a marketing authorisation is not available in Finland. The special permit procedure ensures the medical treatment of an individual patient in exceptional cases by granting a permit for a medicinal product that does not have a marketing authorisation in Finland for special medical reasons.
Fimea monitors various transactions that affect the availability of medicines, such as shortage notifications, the number of exemptions to lower the stock of mandatory reserve medical supplies, and the number of exemptions and special permits.
Decisions on mandatory reserve medical supply storage
391
313
478
Decisions on exemption to maintain lower reserve medical supplies
312
270
441
Applications for an exemption received (human medicines)*
198
125
175
Exemption decisions (human medicines)*
189
107
152
Applications for an exemption received (veterinary medicines)*
33
49
60
Exemption decisions (veterinary medicines)*
31
46
53
Patient-specific special permit decisions
7 327
6 809
7 402
Institution-specific special permit decisions
8 465
7 730
8 019
Fixed-term special permit decisions
110
Fimea monitors various variables that affect the availability of medicines, such as shortage notifications, the number of exemptions to lower the stock of mandatory reserve medical supplies, and the number of exemptions and special permits. * For exemptions, the method of calculation has changed, which is why the figures are not directly comparable with previous years’ figures.
The total number of notifications has increased annually. The growth of the R group in 2022 may be due to the post-coronavirus removal of restrictions, which has been reflected in an increased demand for antibiotics.
By anticipating the availability of medicines and medicinal products needed in various crises in Finland and Europe.
By making proposals to the Ministry of Social Affairs and Health concerning the need to restrict or target the distribution, sale or release for consumption of a medicinal product or substance for a fixed duration or order the prioritisation of a medicinal product or substance in distribution if it is necessary for the protection of public health.
