I am attending the Pharmaceuticals Trade Marks Group conference in Dubrovnik. Yesterday I listened to a very interesting and topical presentation by Gilead's Lori Mayall talking about the rise of pharma buyers' clubs and the challenge they pose to originator pharma businesses. 

Most people who work within the pharma sector know that it takes collosal sums of money to do the research and clinical trials necessary to bring a successful new medicine or treatment to market.  And that of the many new projects under development only one or two of those drugs will make it through the hurdles of regulatory approval and become a blockbuster success. Further most people within the sector recognise and accept that the differentials in pricing between different markets are necessary so that revenues earned from sales in more developed markets (such as the USA and Europe) enable pharma companies to offer life saving drugs to emerging markets at a price they can afford. 

Enter the new and growing phenomenon of the drug buyers’ club which is seeking to disrupt the current regulatory framework and distribution channels. Ostensibly altruistic, they claim to assist patients access the drugs they need at prices they can afford by giving them a means to purchase online a drug which may not have been approved in their home market. 

However, there are always two sides to every story and pharma businesses have a number of concerns about the activties of these organisations and their use of pharma trade marks in order to divert medicines intended for emerging markets for their own gain.  

The buyers clubs create a perceived "safe" environment online for patients who are in need of medicines or treatments which for whatever reason are not available to them in their home markets. In doing so they circumvent the regulatory framework put in place to protect patients and potentially patients to counterfeit product, and/or product transported through unregulated supply chains. While sometimes the drugs being purchased through the buyers' clubs are manufactured by licensees of the originating pharma company but intended for distribution to emerging markets, that is not always the case, and the patient has no way of ensuring that the drugs are in fact the correct formulation and are safe to consume. 

One example which Lori cited was a recent notification from the FDA which involved a patient from Colorado who had purchased online drug described as a "generic version" of one of Gilead's treatments against Hepatitis C. When the patient took the drug, he very quickly became ill and was rushed to hospital. When the drug he consumed was tested by the hospital, it was found not to contain any of the active ingredient In Gilead's treatment. 

As healthcare budgets in almost all developed eceonomies are stretched and the demand for life saving drugs continues to grow, perhaps the regulators need to review the operations of buyers' clubs to ensure that patient safety and pharmaceutical brand owners' rights are not compromised.