by Angela Waters
BERLIN, Mar 5 (APM) - Two bills being considered in the German parliament aimed at cracking down on bribery in the healthcare profession could impact the way pharmas promote the use of their drugs, including potentially throwing suspicion on companies offering discounts on medicines, experts told APM.
The first bill was initiated in January by the Federal Ministry of Justice and Consumer Protection, while the second was introduced in Germany’s upper house of parliament, the Bundesrat, by the Bavarian justice ministry earlier this month:
The main objective of both is to cut down on corruption in the healthcare industry by making bribery illegal for the briber and the those accepting bribes - a first in German law.
"It's not about criminalising doctors but protecting patients and the majority of doctors from the few black sheep in the industry," Hannes Hedke, spokesman for the Bavarian justice ministry, told APM. "The draft law is on the one hand aimed at doctors and pharmacists accepting bribes and on the other hand at bribers, especially the pharma industry."
Under current fraud law, cases of bribery can only be prosecuted if damage occurs because of the bribery. Both bills would change this, so suspects can be prosecuted if an unfair advantage is gained.
According to Elmar Mand, a professor in civil law specialising in medical and pharma law at the Philipp University of Marburg in the south-west Germany, any pecuniary advantages or benefits granted to physicians - not only in exchange for subscribing specific drugs - would be precarious and could come under suspicion given the vagueness of both bills.
"The danger of criminal penalties for ‘innovative efforts to increase sales’ is increasing," Mand told APM. “Rebates within the distribution chain of products not subject to price maintenance are not affected - apart from very special cases. However, rebates, gifts, pecuniary advantages, or benefits in kind with regard to drugs (medicinal products) that are subject to price regulation are problematic."
Mand added while there is some room for such practises, higher rebates are forbidden and "given the vague and wide wording of the new statutory offense … any contravention might be subject to criminal prosecution".
This means that although, the proposed laws do not mention the practice by name, they could have an effect on skonti - whereby pharmas give customers a premium rate for certain payment conditions such as paying before the due date in cash, said Mand.
Skonti are common across the pharma sector and recently came under fire when a German competition body, the Centre for Protection against Unfair Competition, said it was preparing a suit against pharma wholesaler, AEP, into whether its skonti were lawful. (APMMA 41259) (APMMA 41262)
But pharma lawyer Cord Willhöft of law firm Field Fisher said that while the new laws will not significantly change pharma companies day-to-day operations, they would put the pharma/doctor relationship under the microscope.
"The laws will take a closer look at what doctors are getting paid to do", Willhöft told APM. "If a doctor is getting pad 500 euros to fill out a survey that will be questionable, but most pharmaceutical companies are already following voluntary anti-corruption measures."
The Bavarian justice ministry said that the Bavarian bill was deliberately "abstract" in order to allow judicial decisions to fill in the blanks on a case-by-case basis but consumer advocacy groups such as Transparency International, which have been lobbying for an anti-corruption laws, are disappointed with both proposed laws.
Wolfgang Wodarg, a board member of Transparency International told APM the laws are too vague to punish corrupt doctors.
“Many doctors are privately employed and their bosses are the ones dealing in corruption. It comes into question whether the law is even logical. We are not as concerned about the fairness of competition but more focused on the harm that can come to the public through bribery".
Pharma lawyer Alexander Natz of Natz Law in Duesseldorf said the law is unnecessary - there is already "lots of regulation" around discount and other practices that could be seen as bribery.
"The industry is already aligned with these practices - there are some exception behaviors that need to be excluded but most have already incorporated these practices into their standard operating procedures. Self-regulation by pharmas is working, and it is already restricted what the industry can pay a physician."
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