Q: What led you to get involved in the issue of counterfeit drugs?

I had been working for 10 years on pharmaceutical (and health product) regulatory and policy reform and development in the transitional countries of Central and East Europe (particularly in Russia and the Balkan region) on behalf of the European Commission, when, while working in Kosovo between 2002-2004 to establish effective local pharmaceutical regulation and policy good governance (i.e. creation of a Kosovo Drug Regulatory Authority and strengthening the Kosovo Ministry of Health pharmaceutical policy department), it became clear to me that the biggest threat to the Balkan region pharmaceutical regulatory system was the inability to control a recent massive influx of both sub-standard and ‘counterfeit medicinal products’.

During the 7 years I had spent living and working in Russia I had come across many cases of substandard medicines and medicines with blatant fake packaging, but I never met a true counterfeit medicine until I started working in Kosovo. It was frightening….kids in the only teaching hospital in Kosovo being admitted with medicine poisoning. What was the problem?

I dread to think what the real statistics for morbidity and mortality from sub standard and counterfeit medicines in Kosovo during the conflict and post war period to this day are likely to be. There was no pharmacovigilance system operating in Kosovo at that time for obvious reasons, so installing such a system became an immediate priority from my side during my tenure there.

The counterfeit medicine problem in Kosovo, and its neighbouring entities, was not just due to a breakdown in health sector regulatory structures as a result of the recent Balkan conflict, but a consequence of a wider and more sinister trend in the global pharmaceutical market.

While working in Kosovo I was also tasked to assist the UN International Narcotics Control Board (UN INCB) on narcotics control and drug trafficking intelligence and establish a narcotics control function in Kosovo. It became rapidly clear to me that the two businesses of firstly drug trafficking and secondly medicines counterfeiting were highly inter connected in the Balkan region as well as in other countries in Central and East Europe.

As a consequence of highlighting this problem in the Balkan region to higher authorities in Europe, I was invited by the Council of Europe to write a report on the counterfeit medicine situation in Europe (based on extensive primary and secondary research, written in 2004 and 2005, and which was published in 2006)¹.

When the Council of Europe report was published, I was fortunate to meet, and have the opportunity to work with, a few other key experts on this topic so as to be able to refine and deliver the message that counterfeit and sub standard medicines pose a major threat to achieving satisfactory global public health.

Q: There have been various documentaries, reports and publications on the subject yet the majority of people still seem to only connect the issue of counterfeiting with handbags and other luxury items – is the life-threatening problem of counterfeit drugs getting enough media coverage?

Media coverage on this subject cannot be over done. The average consumer is used to placing 100% trust in their pharmacist and doctor that the medicine (or medical device) they receive is legitimate. Consumers have to realise that medicinal products are consumer products that are actually easier to fake than many other consumer products.

Professional prescribers and dispensers (i.e. pharmacists) have restricted opportunities to authenticate the medical products that patients receive. Any product can potentially be faked in the current world we live in - car parts, airplane parts, handbags, watches, CDs, consumer electrical goods etc. But what is most worrying is the growing trend to fake products that directly impact on human health. The reasons why health products are increasingly targeted for counterfeiting are numerous and have been well covered in many recent expert reports.

Despite the growing evidence of an increasing global public health threat from counterfeit and substandard and counterfeit medicines, there exists still, surprisingly, a significant element of denial of this problem amongst many regulatory authorities and policy making bodies globally. The issue of how to present an accurate public message of this serious public health threat, in a way that does not undermine health systems and legitimate manufacturers, requires serious attention.

There is a lot of scope to create better partnerships between national policy makers, regulatory authorities and legitimate manufacturers to deliver an accurate message on this topic.

Q: What needs to be done to prevent the production and dissemination of counterfeit drugs?

The evidence suggests that medicines counterfeiting is largely carried out by highly organised and well financed international criminal organisations (very often the same people that manufacture and traffic illicit drugs). In order to deal with a sophisticated criminal activity, a sophisticated response is required.

As has been stated by myself and also by other experts in several recent reports, there is no single solution to this growing problem; a broad range of measures are required that cover in no particular order (i) legislation, (ii) regulation (of the entire supply chain), (iii) inspection and enforcement (iv) anti-counterfeiting technology, (v) public communication, (vi) administrative and policy coordination, and (vii) political will.

Another way of looking at this question is to consider what are the weaknesses in the overall system that have allowed counterfeit medicines to enter the market in the first place? There are many weaknesses, but in general there has been a lack of recognition of a problem (if you are not aware of a problem, you won’t find it) and a lack of political will to tackle it. Thus it is perhaps no surprise to see a complete absence of an effective risk management system that is able to cope with this growing public health threat.

Global coordination to deal with the threat is vital, and in this respect the WHO IMPACT initiative established in 2006 has been critical to drive forward the necessary measures. In addition to the global coordination leadership provided by WHO, it is also necessary to have coordination and implementation of measures from regional and national authorities and policy makers.

From the EU perspective (particularly following, the 2004 Council of Europe Parliamentary Assembly Recommendation concerning counterfeiting², the 2006 Council of Europe report on counterfeit medicines, the 2006 European Parliament resolution³, and a growing number of credible recently published articles and reports on the counterfeit medicine problem in Europe), it is both timely and very encouraging that there are strong signs that the European Commission is now taking the counterfeit medicine problem seriously – i.e. through a recent public consultation designed to inform planned potential changes in the EU pharmaceutical legislative and regulatory system that can address counterfeit medicines⁴, the summary feedback results of which have now been published⁵. However, it remains to be seen when and what measures will be introduced.

Concerning the Rest of the World, much still needs to be done particularly in developing countries. Greater assistance from international donors to developing countries to strengthen their pharmaceutical regulatory and enforcement systems is particularly required and to encourage participation and involve these countries more actively in a broader global coalition.

There needs to be a stronger realisation by many parties that medicines counterfeiting is not just an infringement of intellectual property rights; not only is it an economic crime, it is also a serious health crime that preys upon on unsuspecting and innocent victims.

Q: Within Europe is there enough international cooperation between the relevant authorities who should be preventing counterfeit drugs from being disseminated?

Until recently I would have said not, but there are signs now that the situation may be changing.

In my experience, working in drug regulatory affairs over the past 4 years in the old and new EU Member States, there has been an element of denial by some EU Member State drug regulatory authorities of a counterfeit medicine problem which has hindered effective international cooperation on this issue within Europe.

However, there is increasing evidence from several recent different credible sources that the counterfeit medicine phenomenon is posing a growing threat to the public health of European citizens; for example, EU Customs statistical reports of counterfeit medicine seizures, recent reports from some EU Member State Drug Regulatory Authorities, industry non-publicly disclosed seizures and various key independent expert reports (e.g. the recent report from the European Alliance for Access to Safe Medicines on internet pharmacy)⁶.

The extent of the counterfeit medicine problem in EU Member States is, for several reasons, very hard to determine, but it is hard to deny that there is a problem. Official statistics, such as produced by WHO, that say that the EU only has a level of 1% of counterfeit medicines, are potentially misleading in the absence of effective regulatory detection and cooperation in the EU. We have no idea what the real picture is. Surely a zero tolerance approach needs to be adopted as occurs concerning Pharmacovigilance for registered medicinal products?

In the absence of EU level regulations and guidance addressing counterfeit medicines, there has been an ad hoc national approach to tackling the problem, with some EU member State authorities being more proactive than others. For example, the UK MHRA has a relatively high counterfeit medicine detection rate compared to equivalent national drug regulatory authorities in other EU Member States. Is this because the UK has a bigger problem with counterfeit medicines compared to other EU Member States or is this because the UK MHRA adopts a proactive approach to tackling the counterfeit medicine threat and is able to detect the counterfeits?

The UK MHRA has been criticised from some quarters for not being proactive enough in dealing with the counterfeit medicine epidemic, but such commentary has to be put into perspective when one considers the situation in other EU Member States and European countries. Outside of the UK and a few other EU Member States, the counterfeit medicine problem does not receive the same high level of public scrutiny and thus there is less pressure for action. A full audit of EU Member State drug regulatory and customs authority resources (and how effectively they are applied) for addressing the counterfeit medicine threat would be very revealing.

On the positive side, the European Commission has this year introduced a full review of pharmaceutical legislation to address the related issues of counterfeit medicines and parallel pharmaceutical trade with the intention of introducing some legislative and regulatory reform.

I hope that the European Commission has been fully informed by the Council of Europe Report published 3 years ago. It is vital that the European Commission and the Council of Europe coordinate their response and actions to dealing with this threat.

Q: Name four things that can be done to make European patients safer?

I could make a list of 10 but restrict to 4 key and critical issues as follows:

1. Incorporation and adoption of specific legislation and guidance against medicines counterfeiting in the European Commission medicinal product regulations and directives (and which is coordinated with other EU directives concerning other sectors, e.g. customs control, law enforcement)
2. Create a Council of Europe Convention on Health Crime. The concept of Health Crime needs putting into European Law (not just for fake drugs, but should also cover a whole range of other consumer products and services)
3. Developed country assistance to developing countries for strengthening pharmaceutical regulation and policy (e.g. expand the mandate of ICH and more effective donor coordinated funding for supporting the creation of developing country pharmaceutical regulation)
4. Expanding the terms of reference of the UN International Narcotics Control Board (UN INCB). The illicit drug business (i.e. narcotics and psychotropics) are highly connected with medicines counterfeiting. The UN INCB can expand its mandate to cover health product faking.