Value chain for pharmacotherapy
Pharmaceuticals-related development, research and innovations
The facilitation of research and development of pharmaceuticals is a requirement for new pharmaceutical innovations. It is characteristic of the pharmaceuticals industry that the process from inventing a pharmaceutical to a ready to use pharmaceutical is a multi-year one.
The development pattern for a pharmaceutical involves a great deal of regulation, the purpose of which is to ensure safety and quality.
Finnish Medicines Agency Fimea is responsible for the official duties related to clinical pharmaceutical trials, and the National Committee on Medical Research Ethics (TUKIJA) and regional ethical committees are responsible for the ethical assessment of pharmaceutical trials.
The industrial manufacture of pharmaceuticals
The industrial production and supervision of pharmaceuticals are legislated by the EU and international agreements. The processes and practices related to regulation, licences and supervision are for the most part harmonised. Authorities can intervene in practices and processes that compromise the quality or safety of pharmaceuticals or to terminate the manufacture of a pharmaceutical the quality of which does not meet with requirements.
Marketing authorisations for pharmaceuticals
The objective of the marketing authorisations for pharmaceuticals is to ensure the availability of pharmaceuticals that are of high quality, safe and effective. There may be conditions and obligations related to the granting of marketing authorisation, which the holder of authorisation must see to. A marketing authorisation can be applied:
- through a centralised procedure (all EEA states),
- the mutual recognition procedure ( a marketing authorisation granted in one EEA state is also approved in other member states),
- a dispersed marketing authorisation procedure (numerous EEA states at the same time) or
- a national procedure (if it does not have marketing authorisation in other EEA states)
In Finland, marketing authorisations are granted by the Finnish Medicines Agency (Fimea) in cases where the recognition procedure, dispersed procedure or national procedure for marketing authorisation are in question. The European Medicines Agency (EMA) coordinates the processing of applications and the EU Commission grants marketing authorisation for centralised procedures.
Fimea can grant a temporary authorisation (special permit) for a product that does not have marketing authorisation in Finland for special therapeutic or public health-related reasons. Pursuant to the Medicines Decree (693/1987), a special permit can be granted in special circumstances, when no other treatment can be considered or provide the desired result. Special permits are granted for outpatients case by case and to medical institutions institution-specifically. A special permit is granted for one year from the date on which it was granted.
Controlled introduction of pharmaceuticals
The marketing authorisation system does not take a stand on whether the pharmaceutical is necessary i.e. are there already effective pharmaceuticals for the same illness on the market. The purpose of assessing pharmacotherapy is to summarise and assess research evidence on the benefits, adverse effects, costs and cost effectiveness of pharmacotherapy in comparison to other forms of treatment. A health technology assessment utilises methods of health care (HTA, health technology assessment). The purpose of the HTA is to provide information to support decision making. The introduction of new pharmaceuticals should be based on harmonised therapeutic and economic value evaluation criteria.
The purpose of the controlled introduction of medicinal product is to ensure that the pharmacotherapies currently in use are cost effective, meaning that the health benefits achieved with the medicinal product are evaluated in relation to its costs. The use of a medicinal product must be possible so that everyone has access to treatment that is of equally high quality regardless of the illness and its level of severity.
Prescribing pharmaceuticals for outpatients and patients in institutional care
When a pharmaceutical is prescribed, it is assessed whether the patient needs the pharmaceutical or non-medicinal treatment, which pharmaceutical would be more effective and safest for the patient, how the pharmaceutical fits in with other treatments and how the implementation of treatment will succeed as well as the price of the pharmaceutical and the clinical impacts achieved with the cost of the treatment. When pharmaceutical products are prescribed for outpatient treatment, pharmacies are required to dispense the pharmaceutical product to the patient. In hospitals, prescribing refers to a decision on pharmacotherapy, according to which the pharmacotherapy is conducted.
Distribution and dispensing of pharmaceuticals
The regulation of the wholesale distribution of pharmaceuticals is based on the EU medicines directive and distribution is carried out in compliance with international Good Distribution Practices.
Retail distribution of pharmaceuticals
Pharmacies and hospital pharmacies are responsible for the retail distribution of pharmaceuticals The dispensse of pharmaceuticals is the task of retailers. The dispense of pharmaceuticals refers to ensuring that the prescription for a medication and the medicinal product are correct or ensuring that there is a need for non-prescription medicines, the documentation of dispensing the pharmaceuticals, ensuring the implementation of pharmacotherapy with proper guidance and the providing support for the monitoring of the effects of pharmacotherapy. Pharmacies must provide information on pricing, in other words, they must advise customers to use more affordable medicinal products. The dispense of pharmaceuticals at hospital pharmacies includes ensuring that the pharmaceutical order is correct and that the pharmaceutical is in accordance with the basic selection of pharmaceuticals used in the unit, ensuring the provision of information on pharmaceuticals, department pharmacy, as well as ensuring the faultlessness and (good) quality of the medicinal products.
Retail distribution also includes the preparation of pharmaceuticals as instructed by a doctor at a pharmacy or hospital pharmacy.
The task of pharmacies is to ensure the pharmaceutical service of their locality. The amount of medicinal products, the equipment and supplies for administering medicinal products, and the dressings kept by a pharmacy must correspond to the pharmacy’s usual customer needs. Pharmacies and subsidiary pharmacies must be held open so that the availability of medicines is secured. Medicines can be dispensed and sold to the population from pharmacies, subsidiary pharmacies, pharmacy service points and online pharmacies, and to health and social service units from hospital pharmacies and dispensaries. Hospital pharmacies and dispensaries are not permitted to sell pharmaceuticals to patients. There are more than 800 pharmacies, subsidiary pharmacies or pharmacy service points in Finland. A pharmacy service point can sell non-prescription medicines and dispense prescription pharmaceuticals to a customer. Some pharmaceuticals (nicotine products, some registered traditional herbal products and homeopathy products) can be sold by retailers other than pharmacies.
Pharmacy operations are based on licensing procedures. The holder of a pharmacy licence must be a person who has a degree in pharmacy. Additionally, the University of Helsinki and the University of Eastern Finland have the right to operate pharmacies. In addition to a pharmacy, a pharmacist can have at most three subsidiary pharmacies. The ability to dispense pharmaceuticals and provide advice on the use of pharmaceuticals at pharmacies and hospital pharmacies requires the right to practice pharmacy.
A pharmacy, a hospital pharmacy or a dispensary is established with a permit granted by Finnish Medicines Agency Fimea. Pharmacies (excluding hospital pharmacies and dispensaries) are established in Finland to a location area that is a municipality or a part of municipality.
Price of pharmaceutical
Pharmacotherapy given during medical care and other public institutional care is included in the client fee. Pharmacotherapy in private hospitals is reimbursed to patients from health insurance. Vaccinations in accordance with the national vaccination programme are free of charge. An outpatient purchases their own pharmaceuticals from the pharmacy and can receive reimbursement for the costs in accordance with the Health Insurance Act.
The retail price of pharmaceuticals is based on a nationally valid wholesale price, pharmacy’s sales margin calculated on the basis of the wholesale price and the VAT.
- Government Decree on pharmaceutical tariffs (Finlex) (in Finnish)
A pharmacy must pay a pharmacy tax, which is a tax based on the revenue from pharmacy operations. Pharmacies with smallest revenues do not pay a pharmacy tax. The purpose of the pharmacy tax is to balance the income formation of pharmacies of varying size and to support the operating capacity of small pharmacies, i.e. to facilitate the maintenance of a nationwide pharmacy network.
- Pharmacy Tax Act (Finlex) (in Finnish)
Use of pharmaceuticals
Pharmacotherapy is an integral part of comprehensive care. When successful, pharmacotherapy can cure illnesses, slow the progression of illnesses, reduce the symptoms of illnesses and prevent illnesses. According to research however, only around 50% of people suffering from long-term illnesses use pharmaceuticals in the prescribed manner. There are numerous reasons people do not commit to treatment, including their lack of symptoms, reasons related to the price of the treatment, the adverse reaction they have experienced, health behaviour models and attitudes.
To ensure the coordination and safety of pharmacotherapy in its entirety, every medicine user should have a list of their medications. The list can either be written in a paper form or maintained electronically, its form makes no difference. An up-to-date list of all the medicinal products one uses: pharmaceutical product subject to medical prescription, non-prescription medicines, nutritional supplements and vaccinations. In addition to the name of the preparation, the list should include the dose and the reason for the use of the medicine.
In future, everyone will have a possibility to maintain his or her list of medications in My Kanta web service. At the moment, it is possible to view prescriptions, give consents and request a prescription renewal in the service. Read more:
Reliable and sufficient information on pharmaceuticals will impact the successfulness of treatment as a whole. When pharmaceuticals are used in the manner instructed, they have an impact on the prevalence of antibiotic resistance, the costs of health care, sickness absences, premature disability leave as well as even deaths. Advice on medication provided by health care professional is a key source of information on pharmaceuticals use for medicine users.
Controlled end of pharmaceuticals use
To the controlled use of pharmaceuticals belongs also the controlled end of the use. This applies at the level of both, single users and the selection of pharmaceuticals in general. Sometimes end of the use of a pharmaceutical can require a fast decision in case of a new information on the adverse effects of the pharmaceutical or other safety problems. It must be possible to end the use, in particular of new pharmaceuticals that have been introduced with lacking evidence of effectiveness in a controlled manner if the desired effect is not achieved. Also new alternative pharmaceuticals that have come on the market or non-medicinal treatments, the effectiveness, safety and cost effectiveness of which are better than those of the old pharmaceutical can lead to the decision that use of the old pharmaceutical should be ended. However, ending the use must be carried out in a controlled manner, so that changes to patients’ medication can be controlled.
The controlled end of the use of a pharmaceutical has previously been discussed very little. Internationally, the end of the use of health care methods is discussed a lot at the moment. In Finland, the Current Care Guidelines began drawing up the Vältä viisaasti (avoid wisely) recommendations and of the published recommendations nearly half apply to pharmaceuticals.
Pharmacotherapy is effective, if a person takes the medication they need according to the provided instructions, at the correct time and the correct dose. Rational, or sensible pharmacotherapy is effective, safe, of high quality, quitable and cost-effective.
Elina Asola, Senior Specialist
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Biotechnology and Medicines Unit / BILA Telephone:0295163437
Anne Hautala, Senior Specialist
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Biotechnology and Medicines Unit / BILA Telephone:0295163703