Medicine safety comes first
When a medicine is efficient and effective, it can also cause undesired adverse reactions. However, the medicine is correctly manufactured and meets the quality requirements – and is safe for the patient to use. The term used by the professionals in these contexts is medicine safety. The legislation, the medicine authorities and the pharmaceutical companies together ensure a high level of medicine safety.
The ultimate objective of pharmacotherapies is to cure or prevent diseases or prevent patients from getting worse as well as alleviate their symptoms.
Verifying safety takes time
The development of a new medicine starts at the laboratory. When new information on its properties starts to accumulate, its usability, in other words its safety and efficacy, must be demonstrated on humans.
Individual trials go on for months or even years and it takes over 10 years to complete the whole documentary evidence on safety. The process cannot be speeded up without risking safety.
Safety is not compromised even when the authorities think that quicker development would be a smaller risk than leaving the patient without therapy. This is the case, for example, when the population faces the threat of an infectious disease or other illness with no known cure.
Pros and cons in one single medicine
The effects of medicines on the human body are individual. A medicine that may bring the desired remedy in one person may cause such serious adverse reactions in another that the medication must be changed to prevent any permanent consequences. There are no medicines that could be completely free from adverse effects on all people.
Obligation and responsibility to inform about adverse reactions
The Medicines Act urges professionals to notify any unexpected adverse reactions.
• The doctors and pharmacy staff must inform the Finnish Medicines Agency FIMEA about any medicine-related adverse reactions.
• All healthcare professionals must inform the Institute for Health and Welfare THL of any vaccine-related adverse reactions.
Follow-up throughout medicine life
The companies shoulder product liability from start to finish.
Pharmacovigilance within the pharmaceutical companies includes the gathering of information on the adverse reactions of medicines. The companies must be aware of the properties of their products after they have been introduced to the market. The active follow-up of medicine safety must continue throughout the life of the medicine.
The group of people involved in clinical trials is always limited, and the samples do not necessarily include the rarest adverse reactions. Adverse reactions may have emerged even decades after the introduction of the medicine.
If necessary, the authorities can require warnings to be printed in the summary of product characteristics SPC of the medicine, or limit its use.
Pharmaceutical insurance cover is more comprehensive than product liability insurance
Product liability insurance covers any damage caused by a faulty product. In many countries, this is a common insurance form. Product liability insurance is specific to the company in question, and the claims are made directly to the company.
For a good many years, Finnish medicine users have been protected by a more extensive, voluntary and joint insurance for medicines-related injuries taken out by the pharmaceutical branch.
The insurance for medicines-related injuries indemnifies any adverse reactions caused to the users by the medicines released for consumption or used in clinical trials in Finland. The medicine is such has no fault but the adverse reactions are unexpected in the therapy situation.