IMI – Innovative Medicines Initiative

Patients can rely on the 'safety' of medicines that are prescribed for them. All drugs are tested in every conceivable way – for efficacy, tolerability and possible adverse side effects – in the course of their development: first in a test tube, then in a cell culture, after that in animal tests, and finally in clinical trials with patients. Patients are constantly being reminded to ask their doctor or pharmacist for information on risks and side effects. Furthermore, every drug's benefits and known risks are listed in detail on the package insert. Even so, this knowledge cannot be complete, because a drug can only be tested on a few thousand people before it is approved – for legal and ethical reasons.

"These days we usually seek market approval in many countries at the same time, for example Europe-wide. This means that a new drug may be prescribed to tens of thousands of patients within a very short time," says Dr. Matthias Gottwald, who is responsible for IMI at Bayer Schering Pharma. Statistically speaking, very rare effects or interactions with other drugs can only occur in very large patient populations. This is why the product must be constantly monitored on the market to be able to recognize and analyze risks quickly and, where necessary, to take steps to minimize any risk – e.g. by publishing new restrictions on use or dosage recommendations. "You need specialists worldwide in this field. You need not only medical and pharmacological knowledge, you must also be familiar with statistics, epidemiology, and regulatory issues," Dr. Gottwald emphasizes.

Pharmaceutical companies and academic institutions have therefore come together in the IMI and are jointly developing both a European master's degree course and a three-year doctorate program in this important field. This is the Eu2P project (European Program in Pharmacovigilance and Pharmacoepidemiology). Both programs are aimed at students of medicine, pharmaceutics and the natural sciences who want to work in the pharmaceutical industry. However, people from industry and government agencies can also improve their qualifications in this way. All subject modules will be accessible via a Europe-wide e-learning platform. In addition, a certifiable course will be set up for interested non-professionals such as representatives of patients' organizations.

Pharmacovigilance is the ongoing and systematic monitoring of a finished drug's safety. According to the definition of the World Health Organization, WHO, this includes activities that are necessary to discover, assess and prevent problems related to drugs, as well as manage the risks involved.

The first surveillance systems were set up in many countries as early as the 1960s, not least because of the thalidomide case. In the meantime, a close-meshed safety network has developed which includes a system of collecting spontaneous reports by physicians, pharmacists and other healthcare professionals. The most intensive form of this concept is known as prescription-event monitoring. After the product has been launched, the first 10,000 patients who are being treated with it are identified; the prescribing physicians then query them about all side effects. The long-term promotion of drug safety is assured by the establishment of national and regional pharmacovigilance centers.

Pharmacoepidemiology is an interdisciplinary basic science. It conducts research into the effects of medication use on the population. This includes not only clinical, but also sociodemographic and psychological aspects. Some long-term studies interview and examine thousands of patients in this context. The WHO regularly publishes topical reports on adverse drug reactions.

On the academic side, the universities of Bordeaux (F), Rotterdam (NL), Utrecht (B), Verona (I) and Hertfordshire (GB), as well as the Karolinska Institute in Stockholm (S), are participating in Eu2P. The group of 15 industrial partners includes Roche, Amgen, Astra Zeneca, GlaxoSmithKline, Sanofi-Aventis and Novartis.