FOCUS Online The Berlin-based virologist Christian Drosten calls, in the fight against Covid-19 of the “unusual options” in recital. You have to set the rules for the development of vaccines to be in force, when rates increased deaths in the Elderly to prevent wool. This is legally even possible?

Fabian Huber: of Course, it is not possible to put the medicines regulations simply “override”, even if it is a very desirable goal to be achieved. Finally, there is the case of medicinal products still Were of a special nature, whose inherent danger is reduced in potential by the observance of of the pharmaceutical legislation at least. In special cases, and, of course, only under narrow circumstances – must, however, be of particular medicines regulations waived.

vaccine to the market faster

FOCUS Online bring : What, for example?

Huber : In terms of the Coronavirus (SARS-CoV-2) may be the exceptions to the AMG’s-to draw civil protection of the exception regulation. This regulation provides, for example, for the area of civil protection and disaster protection, but also exceptions of the pharmaceutical regulatory Approval. With the help of these exceptions, a vaccine could be brought quite quickly to the market without that drug-related legislation “should be repealed”. About the experts

Fabian Huber holds a PhD in law and works for the Munich office of international law firm Simmons & Simmons LLP in the Healthcare and Life Sciences. He advises on regulatory aspects of medicinal products and medical devices.

FOCUS Online : With a view to the possible side effects of a vaccine, the the usual phases of clinical testing does not go through, called the chief of Virology at the Charité hospital in Berlin: “For such a risk would be liable to the state.” What do you think of such a proposal?

Huber : Basically, I think, of course, a lot of it, if in the case of medicinal products damage liability. Just then, though, the state has a substantial interest in a drug and urging to bring it faster than usual on the market, it should be considered as a reasonable liability for participation could be possible.

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FOCUS Online : How could these look like?

Huber : The concrete proposal would be a state product liability, the there are so. It is not the state of the medicine – making a vaccine or on the market. In this respect, I think this proposal is rather less, especially since the medicines act provides, in principle, for a (physical) protection of the patient. It is different, of course, if a vaccination would, for example, recommended by the authorities, or even arranged. Here would also be liability of the state for damage in accordance with the provisions of the infection protection act.

In General, the pharmaceutical entrepreneur

FOCUS Online : Who bears the risk of possible compensation claims?

Huber : Basically, the pharmaceutical companies for drug damage, so the owner of the drug is legal authorisation, or the medicine under its own name in the market is liable. Such liability is determined from the relevant regulations on liability for drug damage. These rules can be modified in certain cases, to the benefit of the pharmaceutical entrepreneur. For example, the protection of the exception regulation would be to the AMG-Civil no liability due to lack of package inserts and under certain conditions even no liability.

FOCUS Online : Especially in the case of vaccines, the requirements of proof of efficacy and safety are very strict and the approval process take a long time. What are the possibilities to accelerate in such a Situation, the legal registration procedures?

Huber : In such a Situation, the Foundation stone for the acceleration can be laid even when selecting the correct authorisation procedure. The drug law, namely, in addition to the “normal” approval procedures, among other things, an accelerated assessment procedure, which leads to a full authorisation, but within shorter period of time shall be granted or a conditional approval, which is limited in time, and in the further evidence to be provided. In addition, it is expected in such a Situation that the authorities provide for an acceleration, for example, by a priority processing of applications for authorisation, or with an increase in staff capacity.

Standard approval process probably never overridden

FOCUS Online : do you Know examples from the past, where the usual registration procedure has been abrogated?

Huber : I am not aware that the drugs were legal provisions for the authorisation procedure is ever “out of power”. From the reason mentioned above, this does not appear to me but also very likely. However, the Federal Ministry of health has, with the exception of the AMG-civil protection, the exception in regulation several times already, at least brought into play: in connection with an Ebola epidemic in the years of 2013 and a Corona-epidemic (SARS-CoV) in 2015.

FOCUS Online : Should be used with other existing vaccines, which have been already tried for the old Sars Virus clinically?

Huber : The use of existing vaccines against the Coronavirus (SARS-CoV-2) requires that the appropriate vaccines are tested specifically in relation to the Coronavirus (SARS-CoV-2) in accordance with the medicines legislation, and (in principle) have been approved. A vaccination, “into the blue”, just because appropriate vaccines were tested for an old Coronavirus (SARS-CoV), not only from a legal point of view, unacceptable. All the important messages to the Coronavirus in the FOCUS Online Newsletter. Subscribe now.