Medicines are used to restore the body's normal physiological functions. When a medicine works, it impacts the body functions pharmacologically, immunologically or metabolically.
The development of a novel medicine is a long and expensive process. It will take about eight to twelve years to turn an idea through research into a product with a marketing authorisation. The development of one medicinal product requires an investment that exceeds one billion euro.
Life cycle of outpatient medicines
The development of a new medicine starts at the laboratory. It continues with animal testing, followed by clinical trials on humans. The research and trials generate the information on medicine safety and efficacy needed for the marketing authorisation.
A new medicine will not receive its marketing authorisation without the indispensable animal tests. The industry's objective is to reduce animal testing, using other methods instead, as well as to avoid causing pain to the test animals.
In 2013, EFPIA (European Federation of Pharmaceutical Industries and Associations) launched a web service called Animal Testing Perspectives. The site is an open discussion forum focusing on the use of animals in European biomedicine.
The marketing authorisations are granted by the Finnish Medicines Agency Fimea or the European Medicines Agency EMA. The Pharmaceuticals Pricing Board PPB decides the reimbursable price of the medicine. All these steps are required before the medicine is accessible to the patient and is reimbursed by the health insurance system.
Development of pharmacotherapies safeguarded through patent and regulatory data protection
The patent protects pharmaceutical innovations, encouraging inventors to develop new medicines. The patent on a novel medicine will remain in force for 20 years at most.
Part of the protection period is taken up by the development stages preceding the medicine’s entry into the market. Once the protection period expires, generic medicines with the same active ingredient start to be introduced.
Pharmaceutical branch is highly regulated
Working under the Ministry of Social Affairs and Health, the Finnish Medicines Agency Fimea is the supervisory authority for medicine sales, marketing, safety, manufacturing and use. A well-functioning dialogue with the regulatory authority is important for the industry.
The members of Pharma Industry Finland are also committed to respecting the PIF Code of Ethics (PDF) in their pharmaceutical marketing.
Intensive development of pharmacotherapies
Medicines are an integral part of the treatment of patients. Currently, a growing number of diseases can be treated through medication.
Pharmaceutical development has revolutionised healthcare. A growing number of diseases can be treated outside the hospital, and many operations can be done in day surgery. The social importance and significance of pharmacotherapies for the treatment of many major public health problems have been discussed, for example, in the reports by the Nordic Healthcare Group (NHG).
Currently, pharmacotherapies are evolving from the use of general medicines suited for most patients towards more individually targeted products. Precision-medicines customised for individual patients will be able to cater for genetic factors, as well as for the nature and course of the disease in question. Already, many antirheumatics and cancer medicines represent this new generation of medicines.
EMA (Europran Medcines Agency)
Read more about PIF’s collaboration with the authorities.