Drug tests may be conducted on "persons incapable of giving consent" – even if they have no direct benefit.
A geriatric nurse looks through patient files Photo: dpa
In the future, Germany will allow patients suffering from severe dementia to participate in research studies. The Bundestag voted by a majority in Berlin on Wednesday to lift the previous ban. In the decisive vote, 330 deputies voted in favor of the motion by SPD health politician Karl Lauterbach and other deputies from all parliamentary groups. There were 243 votes against and eight abstentions. The final vote on the bill is expected to take place this Friday.
In the preceding debate, which lasted almost two hours, both sides had strongly advocated their positions. Opponents and supporters of liberalization exist in all groups. The vote took place without factional coercion. The opponents around the former Federal Minister of Health Ulla Schmidt (SPD) had first forced the extensive consultations on the sensitive ethical issue. The vote on the bill by Federal Health Minister Hermann Grohe (CDU) had to be postponed several times. They received 254 yes votes for their proposal.
Up to now, the participation of patients who are unable to give consent, i.e. including patients suffering from dementia, in clinical trials has only been permitted if they can hope for an improvement, for example through new drugs. Grohe assured that the protection for study participants would be higher in Germany than in all other EU countries, even after the change in the law. The majority motion, which Grohe also supported, stipulates that study participants must deposit their consent in an advance directive if they are still healthy enough to do so. To do this, they must seek advice from a physician.
Grohe said he was concerned by the "anti-research tone" in the debate. Part of being human, he said, is being able to choose to contribute to research into the disease. The coalition has done a lot to improve care for dementia patients. But it is just as important to ask how this disease can be better researched, he said.
Vote across the parties
The health policy spokeswoman of the left-wing parliamentary group, Kathrin Vogler, on the other hand, made it clear that the supporters of the ban were not opponents of research. However, they objected to jeopardizing the protection of a particularly vulnerable group of patients: "The high level of protection for test subjects is not an obstacle, but a quality feature for Germany as a research location," she argued.
Vogler, Green Party health expert Kordula Schulz-Asche and Ulla Schmidt criticized the advance directive as offering no protection. No one can know long before participation in what kind of study he will later participate, Schmidt said. As a dementia patient, however, he or she would then no longer be able to assess the benefits and effects of the research. Hubert Huppe, a member of the CDU, warned against opening a door that could no longer be closed when dealing with patients who were incapable of giving consent.
In contrast, the advocates of liberalization stressed that it is about the right of self-determination of people who are willing to participate in studies to research Alzheimer’s and dementia. There are currently 700,000 people with dementia in Germany, and their number will double, said Petra Sitte, parliamentary director of the Left Party. Karl Lauterbach, vice chairman of the SPD parliamentary group, said that advanced dementia could only be researched on patients in an advanced stage. However, he also said that there were good reasons for all positions represented in parliament. No one could deny the seriousness of the other.