Bayer HealthCare joins the European Alliance for Access to Safe Medicines

The European Alliance for Access to Safe Medicines (EAASM) was formally launched in the European Parliament on November 20 at a dinner debate hosted by Bill Newton Dunn MEP. EAASM is a non-profit, intersectoral coalition comprising patient groups, health professionals, academics, non-governmental organizations, the pharmaceuticals industry and policy-makers representing European patients’ rights to access safe medicines. The Alliance acts to raise awareness of the risks of counterfeit and substandard medicine to patient safety, to address the shortcomings of current legislation and enforcement, and to campaign for greater protection for European patients. Bayer HealthCare is one of the the first founding members from the European pharmaceuticals industry.

• www.eaasm.eu

Harper Report on parallel pharmaceutical trade

The focal point of the debate was an in-depth report detailing pharmaceutical parallel trade (PPT) in Europe. This independent report, which reviews the implications of European distribution channels with regard to patient safety, was produced by Dr. Jonathan Harper, a leading authority on counterfeit medicines and the European distribution chain.

20 recommendations to protect the patient

Having conducted his investigations and analyzed the evidence, Dr. Harper formulated 20 specific recommendations to protect European patients. Of these, twelve recommendations relate to parallel pharmaceutical trade. The extent of the problems identified in the report was highlighted by Dr. Harper: “Parallel pharmaceutical trade complicates the European supply chain in myriad ways.”

Focusing on the supply chain to fight counterfeited medicines

“Given the increasing concerns related to pharmaceutical supply chain security, and in particular the threat of counterfeit, adulterated and diverted medicines, there are good grounds for reviewing the entire operation of European PPT,” added Harper. Commented Mr. Jim Thomson, Chair of the EAASM, “Dr. Harper’s report is written from a patient safety perspective and makes a number of recommendations to better secure the pharmaceutical supply. There is no doubt that some of these recommendations are key to increasing patient safety and should be actively considered by European legislators.”

Dr. Claus Moritz Trube, Head of Global Anti-Counterfeiting, represents Bayer HealthCare in the Alliance.

Interview:

Why did Bayer HealthCare join the Alliance?

EAASM is a unique institution in Europe which enables a common message to be disseminated by all relevant parties focusing on better protection of the patient. Drug counterfeiting cannot be compared with other kinds of trademark violation – the patient is regularly completely unaware of the fact that he receives, and in many cases has even paid for, a fake and, what is even more worrying, about the dangers for his or her health. The patient is the last person in the illegal supply chain of counterfeited and substandard medicines, but he or she is the first whose health, and in some cases even life, is threatened.

Why is the industry so concerned about this problem?

The problem is growing constantly. For example, over 2.7 million fake medicines were seized at EU borders in 2006. That is a rise of 384 percent compared to 2005. Counterfeiters hide behind the names of genuine manufacturers and misuse the reputation of genuine medicines. They disregard any responsibility and hold no liability for the quality of the products they manufacture or sell. No quality regulations, no supervision by health authorities may ever touch them. This naturally damages the reputation of genuine medicines, reduces the patient’s trust even in those who really do care about his health and may even lead to unjustified complaints and incorrect medical information regarding the genuine medicine. Those who are really concerned about the threat of counterfeit medicines, regardless of whether they come from the industry, patient organizations, authorities, or regulators etc. have to work together to act jointly against this danger and to strengthen the voice of the patient.

But many patients in Europe intentionally buy counterfeit drugs via the Internet. So it seems that there is a demand for these products.

Counterfeited medicines find their way to Europe in various ways, one of which is via the Internet. But most patients are unaware of the dangers and the real quality of the products they receive. More awareness and education about the dangers is necessary. However, it is difficult, if not impossible, for a patient to be absolutely sure whether an Internet pharmacy is safe or not. Some patients are also looking for services a legitimate pharmacy simply cannot offer, especially the delivery of prescription medicines without a prescription. Patients have to be informed that counterfeited pharmaceuticals represent a real threat to their health and that therefore there is no benefit connected with illegal sources whatsoever.

Which other institutions exist besides the EAASM?

There are several global, regional and national organizations and institutions focusing on the dangers of counterfeiting. In regard to the problem of counterfeited pharmaceuticals I would like to mention two global institutions: the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) established by the World Health Organization (WHO) and the Pharmaceutical Security Institute (PSI). Bayer HealthCare is a member of PSI and also contributes to the work of IMPACT.