Germany's drug regulatory body is attacked

link @BMJ

Annette Tuffs

¹ Heidelberg

The independent institute that assesses new drugs in Germany is facing criticisms similar to those aimed at its equivalent body in the United Kingdom, the National Institute for Health and Clinical Excellence.

Last week in Cologne a member of an association for people with diabetes and representatives of the drug industry walked out of a hearing of the Institute for Quality and Economic Efficiency in Health Care in Cologne because they were not allowed to record the hearing, which was on the use of short acting insulin analogues.

The institute has provoked anger among patients' groups and the drug industry by saying that no evidence has been shown that short acting insulin analogues had any advantage over human insulin (BMJ 2006;332:874).

After the walk-out drug firms accused the institute, which was founded in 2004, of insufficient transparency. The institute's director, Peter Sawicki, said that its rules did not allow participants to record hearings and that this had always been the case.

Tension between the drug industry and the institute has grown since the German government proposed expanding the institute's role, so that it will no longer consider only the clinical effectiveness of new drugs but also their cost effectiveness. The proposal is part of the government's package of reforms currently before parliament (BMJ 2006;333:720, 7 Oct).

The institute's evidence based evaluations will become the basis for decisions by the federal joint committee of doctors, health insurance companies, and patients' representatives that decides which treatments will be reimbursed by the state health insurance companies. Under the new reforms this committee will include independent members as well as representatives of doctors and health insurance companies chosen by the health ministry.

"For the analysis of the cost effectiveness of treatments we will use internationally accepted methods, just as we do for looking at the scientific evidence," said Professor Sawicki.

Before his institute can carry out any analysis, however, the government will have to decide what costs are to be taken into account when weighing up a drug's cost effectiveness—whether it is the costs to the health insurance companies, the health system, or the social security systems.

Dr Sawicki said that a public debate is needed involving the federal ethics committee and other institutions to consider the use of monetary equivalents of measures of clinical effectiveness such as survival and number of quality adjusted life years.

The institute's work is also under pressure because of difficulties in recruiting experts. Each project is advertised on the institute's homepage (www.iqwig.de), and renowned experts are also directly asked to apply. "However, experts have to be familiar with the methods of evidence based medicine, and this is not so common in Germany," said Professor Sawicki. They also have to be expert on the particular treatment. They have to spend a considerable amount of time on the preparation of a report, on average 100 (paid) working days.

"Another new problem is pressure from peers, which recently has forced one expert to withdraw for career reasons," said Professor Sawicki. Besides recruiting experts from abroad, he hopes to solve the problem by setting up small independent centres, with the help of government funding, in German university hospitals that have expertise in evidence based medicine.