2.1 End hunger by 2030 and ensure that everyone, especially the poor and the disadvantaged, including young children, receive enough safe and nutritious food throughout the year.
Challenge
Safe and effective medicines are needed for the treatment of production animals in order to properly prevent and treat animal diseases. Only medicines for which the safety of residues has been studied may be used for production animals. The medicine shall be administered in such a way that the safety or quality of food derived from the animal (meat, milk, eggs, honey) does not unnecessarily deteriorate or cause significant harm to humans or the environment. For example, precautionary periods should be observed in the use of medicines to prevent the presence of medicinal residues harmful to human health.
Excessive use and misuse of antimicrobials (antibiotics) in both humans and animals increases the development of resistant microbial strains (antimicrobial resistance) and poses a growing threat to human and animal health worldwide. In some countries, antimicrobials may also be used to promote the growth of production animals, but the practice has been banned in the EU since 2006. The weaknesses of environmental legislation in countries where pharmaceuticals are produced and wastewater discharges from pharmaceutical plants significantly increase the risk of the development of antimicrobial resistance.
Fimea’s role and goals
In Finland, the medicinal treatment of production animals is supervised by both Fimea and the Finnish Food Authority. Fimea grants marketing pharmaceutical companies the authorisations for veterinary medicines and supervises the efficacy, safety and quality of veterinary medicines. The Finnish Food Authority (pdf, in Finnish) supervises and guides the medication of production animals.
In addition, Fimea monitors the adverse effects of veterinary medicines, carries out inspections of the pharmacovigilance functions of marketing authorisation holders, i.e. pharmaceutical companies, monitors clinical trials of veterinary medicines, keeps statistics on the sales of antimicrobials in animals, and grants special permits for veterinary medicines.
How the achievement of the goals is assessed
Fimea ways of promoting the safe medicinal treatment of production animals include the following:
Evaluating and granting marketing authorisations for medicinal products for veterinary use.
Providing scientific advice to operators in the veterinary medicine sector and organising medication counselling clinics.
Ensuring the availability of veterinary medicines by:
Monitoring and investigating shortages of veterinary medicines with pharmaceutical companies. Fimea maintains a list of current shortages on its website.
Promoting the availability of veterinary medicinal products by means enabled by the Veterinary Medicinal Products Regulation, for example by granting special permits and exemptions for veterinary medicinal products.
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.
Estimating the withdrawal period for veterinary medicines in connection with the granting of marketing authorisation and special permits. Withdrawal period refers to the minimum period of time from administering the last dose of medication and the use of meat or other animal-derived products for food.
As part of the marketing authorisation process, an environmental risk assessment (ERA) of the active substance of the medicine is carried out, possibly using external environmental experts. The ERA pays particular attention to endocrine disrupting compounds and the risk of so-called secondary poisoning in vertebrates and invertebrates used for human consumption.
In line with the EU Pharmaceutical Strategy, guidance and resources are now directed at global AMR management work. One of the goals of European Commission’s 2020 Farm to Fork Strategy is sustainable food production and the promise to halve the use of antimicrobials for production animals and aquaculture animals by 2030.
Fimea aims to safeguard the availability of old antimicrobials and encourages the development of new antibiotic treatments where possible.
Fimea monitors the sales of antimicrobials and the situational picture of antimicrobial resistance in production animals, and certain antimicrobials are reserved only for human medicinal treatment (Veterinary Medicines Decree, 2022).
Protection of the environment and reduction of pharmaceutical waste
UN Sustainable Development Goal 3:
3.9 By 2030, significantly reduce deaths and diseases caused by hazardous chemicals and air, water and soil contamination and pollution.
UN Sustainable Development Goal 12: 12.4 By 2030, ensure environmentally sustainable handling of chemicals and waste throughout their life cycle in accordance with agreed international frameworks and significantly reduce their release to air, water or land in order to minimise adverse effects on health and the environment.
Challenge and goals
Promotion of health is about preventing and treating illnesses, but it is also about environmental issues.
Pharmacotherapy is a key part of the comprehensive treatment of illnesses. If pharmacotherapy is successful, it can be used to prevent, cure and slow down diseases as well as alleviate symptoms. In outpatient care, a pharmacy is ordered to deliver the medicinal product to the patient, whereas in the hospital, pharmacotherapy is carried out in accordance with the decision on pharmacotherapy. Pharmacotherapy serves its purpose when the user uses the medicines that they need and uses them according to instructions, at the right time and at suitable doses.
* Includes human and veterinary medicines. ** Medicine sales transactions in pharmacies, subsidiary pharmacies, pharmacy service points and online pharmacy services. *** With a prescription issued by a physician, dentist, veterinarian or, in certain cases, a nurse. An indicator of consumption per kilogram is under development. Source: Finnish Statistics on Medicines 2021.
In practice, these conditions are not nearly always met. According to research data, only about one third of medicinal treatments are carried out as planned. In addition, outdated and unused medicines produce a lot of pharmaceutical waste every year, which is disposed of by incineration. Materials and energy used in the life cycle of the medicine that was not used have been wasted.
Incineration of pharmaceutical waste generated in Finland in 2017–2021, t/year
Pharmaceutical waste delivered to incineration abroad
105
205
176
201
173
196
Total
143
593
361
1 120
1 158
* Waste categories LoW 180108, 180109, 180207, 180208, 200131 and 200132, includes both human and veterinary medicines. Source: YLVA information system.
Therefore, attention must be paid to the appropriate manufacture, packaging and package size, transport, use, storage and disposal of the medicine (or medicinal product). The packaging material and method are primarily chosen so that it is appropriate and adequately protects the product. The packaging must also be as easy to use as possible and safe for transport, storage and children. Due to the quality requirements, recyclable packaging materials have so far not been suitable for the packaging of medicines. Pharmaceutical residues may also be a challenge in the recycling of used pharmaceutical packaging. In Finland, the correct disposal of medicines is supervised by regional administrative authorities, Centres for Economic Development, Transport and the Environment and the Finnish Environment Institute.
The manufacture of the active substances in medicines mainly takes place in countries outside the EU, such as China and India. However, most of the pharmaceutical chemical load in the environment arises after the use of the medicine when it is excreted or flushed out of humans or animals. For this reason, the environmental impacts of both human and veterinary medicines are already assessed at the marketing authorisation stage. Promotion of health is about preventing and treating illnesses, but it is also about environmental issues.
Fimea’s role
Fimea develops the pharmaceutical sector, promotes rational pharmacotherapy for the health of the population and looks for new perspectives and innovative and sustainable practices.
As part of the marketing authorisation process, an environmental risk assessment (ERA) of the active substance of the medicine is carried out, possibly using external environmental experts. In addition, Fimea engages in EU cooperation with other authorities conducting ERA assessments. If necessary, efforts will be made to reduce the risks to the environment of medicines used for humans. A negative ERA assessment of a veterinary medicine may lead to the rejection of a marketing authorisation application. Appropriate package size is also assessed in connection with the marketing authorisation application for medicines.
To promote rational pharmacotherapy, Fimea compiles information packages that discuss an up-to-date list of medicines, the identification and prevention of pharmacotherapy problems, and the assessment and supervision of pharmacotherapy.
Fimea participates in the work of the AdHoc working group of the European Commission’s Pharmaceutical Committee, provides expert assistance and provides information in the SUDDEN and Generation Green projects. In addition, Fimea’s environmental working group consisting of experts participates in commenting on regulations, instructs operators from the environmental perspective and provides preventive advice.
How the achievement of the goals is assessed
Fimea has promoted environmental protection in ways including:
In 2022, Fimea advocated more efficient supervision of pharmaceutical waste treatment by pharmaceutical manufacturers in connection with the reform of the legislation on good manufacturing practices (GMP) for active substances.
Inspections of pharmaceutical manufacturers carried out by Fimea also assess wastewater treatment. The inspections of hospital pharmacies, pharmaceutical centres and contract manufacturing pharmacies monitor deficiencies related to pharmaceutical waste and ensure that the deficiencies are corrected appropriately.
As part of the report on a national centralised medicinal data repository, produced in 2022, Fimea has surveyed the possibilities of promoting awareness of the environmental impacts of medicines. Similarly, the possibilities of reducing the environmental impacts of medicines have been highlighted in the activities of the medicines information network coordinated by Fimea (referred to in the Medicines Information Strategy).
Participating in discussions on the sustainable development of medicinal products and packaging at EU level and cooperating between the Nordic countries. Fimea approves the recycling instructions for empty packaging added in a way that they are not visible on the unopened packaging.
Fimea has aimed to reduce pharmaceutical losses at the national level in ways including:
Supporting the implementation of rational pharmacotherapy. For example, Fimea provides a publication platform for the research results of researchers in rational pharmacotherapy. In 2022, five research results, or so-called Policy Briefs, were published on the Fimea website.
Carrying out mystery shopping studies, the aim of which is to examine the implementation of OTC medication counselling in the services of Finnish pharmacies.
Based on the mystery shopper studies of Finnish pharmacies in online and other distance selling services conducted by Fimea in 2021 and 2022, the connection between the mystery shopper and the customer service provider was most commonly realised only after the purchase had been paid for. Rarely advised topics included non-medication treatments and the duration of pharmacotherapy. Based on this, pharmacy supervision carried out by Fimea is increasingly targeted at pharmaceutical advice provided in (online) pharmacies to better support rational pharmacotherapy.
Supervising the compliance of operators subject to mandatory reserve medical supply storage obligations and, if the conditions are met, granting exemptions to maintain lower or no stocks of mandatory reserve medical supplies on application.
