EFPIAs Director General Richard Bergström puts forward his views on the counterfeiting of medicines, the impact on patients, and what is being done to solve the problem.
Counterfeiting is an age old issue. It is now a global problem where every sector of our economy has been affected. However, the consequences are different when it comes to counterfeit medicines; the main concern is not so much the loss of revenue to our industry but the health of patients.
Far from being a developing world issue, substandard and falsified drugs medicines still cause thousands of adverse reactions and some deaths in rich countries. And the issue is growing. To put this into numbers, over 10 % of medicines globally are said to be illegal, representing close to 52 billion euro ($75billion dollars), making it 25 times more profitable than the sale of illicit drugs. Counterfeit medicines have been found in every disease category, and in every region of the world. While 1% of products in the legal pharmaceutical supply chain in the developed world is estimated to be counterfeit, this figure amounts to 10-15% in emerging markets and 30% in developing countries
There is also the internet factor. Illegal online pharmacies are allowed to roam uncontrolled- creating a truly global problem. According to the European Alliance of Access to Safe Medicines (EAASM), 62% of medicines purchased online are fake or substandard and more than 8 in 10 online pharmacies do not actually “physically exist”.
It is difficult not to agree something needs to be done and quickly to address the problem- and there are steps in the right direction. Two years ago the Council of Europe’s MEDICRIME Convention was launched before being opened for signature to all states in October 2011. It now has 21 signatories. The Convention aims to protect patients globally and especially in developing countries. To do so it criminalizes the manufacture and supply of counterfeits and provides “that sanctions and measures should be effective, proportionate and dissuasive”. The EU is also currently implementing its Falsified Medicines Directive and has increased, along with Interpol and its Pangea V programme, its fight against counterfeiting medicines.
At a global level the WHO is also looking into the issue. At a recent meeting in Buenos Aires representatives agreed to strengthen regulations to fight counterfeit medicines and pledged to “outline actions and policies to control and prevent the adulteration of products and guarantee safer, better quality medications at a meeting aiming to establish a mechanism against substandard and counterfeit medical products”.
The sheer amount of initiatives is great. Actually these are necessary if we want to stop what is a global phenomenon. Yet, more thought must be given on how to structure these initiatives, to avoid overlaps but also to make sure that all stakeholders affected are involved in the process. This is a fundamental issue. It is unacceptable to think that patients could take medication that does the opposite of what they are supposed to. Patients need to be able to trust in the medicines they take. As an industry we want and need to take part in finding long-term solutions to ensure that the problem is stopped.
We are already working on solutions. EFPIA along with the EAEPC (the European Licensed Parallel Distribution Industry), GIRP (Groupement International de la Répartition Pharmaceutique) and PGEU (Pharmaceutical Group of the European Union), the European organisations of parallel distributors, wholesalers and pharmacists at EU level, have initiated the European Stakeholder Model (ESM). The project aims at implementing concrete options for establishing a system verifying pharmaceutical products in the EU and this in compliance with the EU Falsified Medicines Directive. It will be run by stakeholder organisations on a non-profit basis.
People will always say that they have the best model, but sincerely I believe we do. Our model is the only one that brings in the full medicine supply chain and many other key stakeholders. These are people who know how the system works and who have a vested interest in it working. The potential advantages include the possibility of allowing the automated checking of expiry dates, better pharmacovigilance, a reduction in the number of fraudulent reimbursement claims, higher effectiveness in preventing recalled products from being supplied to the patient, more efficient handling of product returns and improved stock management processes for pharmacies. Imagine what such a system could do against counterfeiting.
As good as the model may be it needs to go hand in hand with the EU and global initiatives mentioned above. There needs to, for example, be a stronger push to get more states to sign up to the MEDICRIME convention. The rules are not binding at this time, but the symbolism is strong and will only be made stronger as more countries get involved. There also needs to be larger coordination at a global level between enforcement agencies, countries and companies. Cooperation initiatives such as the Alliance for Safe Online Pharmacy EU (ASOP) between the US and the EU need to be the norm not the exception.
The certainty is that the counterfeiting needs to be dealt with swiftly to at least contain the problem before being able to solve it once and for all. Work has started and battle lines are being drawn but a lot still needs to be done- and the quicker the better.