Clinical trials row in Germany

People with mental impairments should not be regarded as "guinea pigs" by the pharmaceutical industry, Schmidt told the daily "Berliner Zeitung" on Thursday.

Amendments to Germany's Medicines Act planned by Health Minister Herrmann Gröhe would allow clinical testing if prior to the onset of dementia the person had signed a consent form.

Schmidt, a center-left Social Democrat and a deputy federal parliamentary speaker, said the procedure amounted to a "fig leaf." She said informed consent assumed that the patient could be briefed about the test's exact purpose, content and risks - a task that's often not possible for patients with dementia.

Clinical testing is a highly sensitive topic in Germany because of murderous experiments conducted during Hitler's 12-year Nazi regime.

In March, when the federal government adopted the draft law, Grohe, a member of Chancellor Angela Merkel's Christian Democrats (CDU), said the procedural inclusion of regional Ethics Commissions would ensure "high quality clinical audits as a prerequisite for quick and secure access to new medicines."

In May, he told Berlin's "Tagesspiegel" newspaper that only minimal-risk studies would be permitted and only when a dementia patient had given advance consent while in "full grasp of his intellectual abilities."

Consent forms

Another German law passed in 2009 and widely promoted by Grohe's ministry and health funds urges residents in Germany to each formulate a Patientverfügung, stipulating what should be done or avoided if they become totally incapacitated. A legal guardian can also be named.

Schmidt on Thursday said a guardian appointed in such instructions did not have the right to let the dementia patient be treated as a "research object."

Last month, the Central Committee of German Catholics (ZdK), a lay body, also demanded stricter rules on how to deal with patients' prior written consent.

"For the safeguarding of human dignity and the autonomy of the individual, it is not sufficient to base this on a Patientverfügung if it only contains a general assent to clinical tests," said ZdK President Thomas Steinberg.

Merely a test person

"When a dementia-suffering, no longer consent-capable patient is regarded as merely a test person for a medical substance, then that is dangerously close to the instrumentation of people for research purposes," he added.

Steinberg said the proposed law would also weaken the role of Ethics Commissions by allowing their votes to be overruled by higher federal authorities.

Current law serves patients better, he said, because it contains a strict obligation that licensing of a new medicine hinged on Ethics Commission approval.

Germany's Pharmaceutical Federation, responding in January to the death of a French clinical test participant, said its members would continue to enact comprehensive safety provisions subject to statutory examination.

'Adequate' information

Article 31 of the EU's clinical trials regulation, which was adopted in 2014 and became effective from 2016, insists that "incapacitated subjects" receive "adequate" information within their "capacity to understand it" and also requires the "informed consent of their legally designated representative."

The regulation also bans "incentives and financial inducements" and requires tests based on scientific grounds beneficial to such patients.

The preamble of Regulation 536/2014 says scientific practice points to the need for "flexible" and "swift" clinical trial procedures across "many, or all, Member States" so that authorization and findings can be "optimized."

The German Alzheimer's Association estimated that Germany's demographically aging population includes 1.5 million people with dementia. Each year, 200,000 people succumb to the disease.

As it advances, patients become unable to recognize relatives and friends, walk or eat. Care at home often results in extreme stress for partners.

ipj/sms (KNA, epd)