The Falsified Medicines Directive: You Have 2 Budget Cycles to Comply

Jim Thomson, Chair, European Alliance for Safe Medicines (EAASM), joins Pharma IQ, to discuss the challenge of pharmaceutical counterfeiting.

Pharma IQ: Could you outline the importance of the EAASM and any important projects you’ve been involved in?

J Thomson: Sure, yes. It would be arrogant of me to say how important the organisation is but I can tell you what we are. We’re a multi sectoral organisation, Pan European patient advocacy group, so we have a large number of patient groups in membership, some industry companies and memberships, and some non-industry companies and memberships as well, together with key opinion leaders, regulatory people, etc – so anybody who is concerned in anti?counterfeiting can be part of the alliance.

Projects – well, our first project back in 2007 when we were formed was the Harper Report, which looked at the European supply chain, and which really put down a marker for the legislation that’s now going through. We then turned our attention to the internet with a project called the Counterfeiting Superhighway, which will attest purchase programme we undertook which found that 62% of medicines available on the internet from pharmacies that conceal their identity, were fake or substandard.

We then submitted to DG Enterprise and Industry, a document calling for some pretty serious changes to the supply chain, and at that point the patient safety argument really hadn’t been made effectively. So we were able to go to DG Enterprise and Industry and say, look, this isn’t an IP issue, this is a patient safety issue and we need to look at tightening the supply chain. That was very successful, rather too successful because Enterprise and Industry, in our view, went too far in calling for some of the things they called for.  So that then stalled and when Marisa Matias MEP took up cudgels with the draft directive we presented her with another document called Packaging Patient Protection, which I think I gave to her on her second day in office. Many of the recommendations in that document can be found in the draft legislation that’s now processing through the parliament.

Pharma IQ: And what kinds of products are counterfeited the most?

J Thomson: You know that’s a really difficult question because it’s across the board really, and it’s something of a moveable piece. You know, people think that it’s the lifestyle, so-called lifestyle drugs, the erectile dysfunction drugs, etc, and to an extent that’s true, yes, and always be. But you know, we’ve had mainstream, lifesaving drugs found counterfeited in the legitimate supply chain, and of very high quality in terms of their appearance; not such high quality in terms of what’s in them, but they’re really high quality in terms of their appearance.

I’d love to know the answer to the question but I suspect that there’s an awful lot that we’re not even finding, A, because we look in the wrong places perhaps, and B, because they’re so very good. But if you ask me to nail my colours to the mast I’d say it’s lifestyle drugs, it’s high value, high turnover drugs, anti-hypertensives, etc.  It’s drugs for stigmatised, and conditions that people are discriminated against for, like weight loss, like mental health, hair loss, embarrassing conditions that people really don’t want to go and talk to their clinician about.

Pharma IQ: Has it become harder to access safer medicines in Europe over the last ten years with counterfeiting on the rise? What do you feel are the causes of this?

J Thomson:Okay, I think this is the showstopper question of the questions that you’re going to ask me actually. Let me turn it on its head – it’s become easier to access unsafe medicines in Europe over the last ten years with counterfeiting on the rise, which I suppose answers your question. I don’t think that it’s necessarily become more difficult to access safe medicines, per se, because that would indicate that the supply chain has got radically worse. I don’t think the supply chain has got radically worse; I think it’s fairly broken, has been fairly broken over the last ten years and is about to improve radically, but it’s true that incidents of counterfeit medicines has risen massively in the past ten years. The European Union has acknowledged that itself – in fact, in the preamble to the current legislation that’s one of the founding tenets that the legislation is based upon. So yes, unsafe medicines have got into the supply chain.

Of course, the advent of the internet and internet drug selling, which is separate to legitimate online pharmacy, if you like, has become incredibly widespread – 25% of all email traffic daily is spam promoting fake medicines, and that’s 15 billion message a day, so it’s become very easy to access unsafe medicines.  The message here isn’t that the supply chain has become inherently more dangerous; people getting their medicines in the conventional way are, I would suggest, very, very safe and hardly any... to any degree more likely to source unsafe medicines than they were ten years ago. The takeaway message there is, yes, the internet is a source of unsafe medicines; so yes, it’s become easier to source unsafe, but not necessarily harder to access safe medicines.

Pharma IQ: With more patients seeking medical information and medicines online, what action needs to be taken?

J Thomson:Yes, there is no doubt; there is doubt whatsoever that the internet is a massive issue here and our first project on the internet, Counterfeiting the Superhighway, identified this. We tried really, really hard not to buy fake medicines, we tried to vet out the obviously bad guys. You know, if the website had been translated using Google Translate from Mandarin or whatever, we didn’t buy from those people, but still, what we bought was 62.8% actual rubbish – so the internet has got a huge role to play, and people are seeking their medical information online. I believe late last year, for the time, more people sought their medical information online than through any other medium – ie, going to see the doctor.

So what action needs to be taken? Well, there are two ways to look at this – A, we can secure the internet, and good luck there because the very ethos of the internet is that it’s a free forum, so it’s very, very hard to regulate and secure the internet. This is one of the areas where Marisa Matheus and I agreed to disagree with the legislation that’s going forward now. We pleaded with her not to roll the internet into this legislation because really, in our view, it’s not the right place for it and it needs to be treated separately, but she wasn’t for turning, and for very good reasons, and I admire and respect her for that. So we can try and regulate it but even in Europe we’re looking at 28 different pieces of internet regulation, and the internet isn’t designed that way; the internet doesn’t acknowledge national borders.

Or, and this is the option I would prefer to see, we can look at this trade, which is in effect, money laundering, and we can say how do we stop this trade? Well, first of all we inform people, we educate people about the risks of buying without a prescription from unauthorised pharmacies online. And that we can do very effectively and actually – I can’t tell you about it – but our next project which is imminently launching is doing exactly that. So you raise awareness, you raise the educative level of citizens about the dangers, and then you look at the choke points and you say, hang on, product has to move here and money has to move – those are the two things that have to happen for this to work.

So we look at stopping the money moving – and here the credit card companies have got a big role to play, and a duty of care that I think actually they’ve been deserting over the years – and we look at the delivery of the medicines, and we work with customs, and we work with the career companies, and we work with the mail providers to stop that happening. Now, there have been great steps made forward in that context in the last couple of years alone – Medi-Fake was a fantastic project and we would like to see that repeated, and certainly the Royal Mail in Europe has done great work as I know many of the couriers companies have. So the search engines have a part to play here, and we’re talking to Google and we’re talking to Microsoft about how they can work with us to help improve that situation as well.

Pharma IQ: Can I just ask – where does the statistic, 62.8% of the products you bought were rubbish come from?

J Thomson: That was from our Counterfeit Superhighway research. We bought... we ordered 33 medicines, 31 arrived and we didn’t have a prescription for any of it, and filled in quite spurious details on these so-called online consultations, and 62% of what came back was fake or substandard. The WHO even accepts that 50% is fake or substandard from these pharmacies that conceal their physical name and address, although I have actually, since our research, have heard WHO people quoting the 62%, so I suspect we’re probably rather more accurate than the 50%. Any short visit online – I could sit with you and take you through this – would yield just a horror story of what’s available online, and it’s not just prescription drugs, it’s controlled substances as well.

Pharma IQ: You mentioned getting the credit card companies and search engines involved – what role is the government playing in all of this, and how effective will their role ultimately be.

J Thomson: Okay, that’s a two-pronged question, as well, because really what we’re looking at here is an area that’s regulated centrally in Brussels. So the package that’s going through at the moment, which I think, you know, if it survives the whole process in the form it’s in now is a very strong piece of legislation and will radically alter the supply chain as we know it – and I know we’re going to come onto that.

So there is this first tranche of legislation which is European, but the key thing about that is that does not limit the ability of the national regulator to go further, if you like. And I know that MHRA has had a couple of consultative process – the first one I thought very good but it was slightly watered down; the second one also reasonable; I think the jury is out is the quick answer. We need to see, once the falsified medicines directive in Brussels gets rubber stamped – and there’s still a long way to go with that – then we’ll see where the MHRA takes that and how, in effect, it can strengthen it to reflect the particular conditions within the British market.

Pharma IQ:New legislation has come in from the EU, coming into force in July, how important will this be, and what will be the impact of this? I guess it’s the same question.

J Thomson: Yes, I don’t think you can over emphasise the importance of it actually; I think it’s the most radical piece of supply chain legislation; well, in living memory actually. It’s three-pronged, and I guess we’re concerned with the third prong, if you like, which is the falsified medicines directive – the other two being pharmaco vigilance and information to patients. When this legislation was first being developed it was thought that the falsified medicines wing of it would be the toughest, but actually it’s the information to patients that’s panned out that way.

It’s phenomenally important legislation – what will be the impact of it? Well, if it goes through in the format it’s at, at the moment, there will be massive impacts on all stakeholders in the supply chain, and all those people that are attending the summit will be affected. So they need to take a pen and make sure there’s a lot of ink in it, and a big piece of paper because there’s an awful lot going on that they may be aware of, but in my experience, very many people at the moment really aren’t aware of, and this process, unlike most European legislations, is happening very quickly. Yes, it will impact everybody from maker to taker, excluding the faker.

Pharma IQ: I understand you’re involved in the recommendations on the new legislation? What were you recommendations, and why?

J Thomson: Okay, we made seven recommendations; five of them are pretty much in the legislation as it stands. The first of those is really that equivalent should mean equivalent. So if a re-packager or any player or any actor in the supply chain is removing a safety feature from an individual pack, then they must replace that with a safety feature of an equivalent standard, and that could be a tamper proof mechanism, or it could be a piece of serialisation that identifies that individual pack.

The second one was that any safety feature should be of a minimum standard, and we recommended a two-D data matrix and a safety feature. The key for that is that if you apply that at an individual pack level – and this is in the legislation that individual packs will be identifiable – then you really mandate serialisation, and that’s random serialisation – so not only can you authenticate that medicine, you can authenticate that individual pack. So a counterfeiter may be able to counterfeit a pack, but he can only do one pack unless, of course, he breaks into a manufacturer’s facility and steals all the codes, which is highly unlikely.

The third recommendation we made – we did some research and thought that API was particularly at risk, to an extent because of where some of it comes from, but also because one fake pack of API makes 250,000 doses level fakes. So we suggested the introduction of series measures to monitor API, to the extent of them being guaranteed – that’s in the legislation. Increase the need of accountability throughout the supply chain – we thought it was incredibly unfair that actually the manufacturer’s accountable, the pharmacist’s accountable, and there is this whole grey area in-between. So if people want to be involved in medicines trading, medicines brokering, then they’re part of the healthcare system and they should be equally accountable – that’s going to be in there as well.

And we asked for interim measures in case this legislation was going to take, on average, six years with the European legislation to get through. If there happened to be an incident that we felt, you know, that we need to introduce some of this stuff now we asked Matinus to provide for that, and that’s all in there as well. The one thing that we did ask for, as I’ve said before that isn’t there, was the disassociation of the internet and special treatment for it – but hey, you can’t win them all.

Pharma IQ: And what’s next in fighting pharmaceutical counterfeiting?

J Thomson: Well, I think global is the answer to that. I think the fight is going to go global, it’s already happening, Partnership for Safe Medicines who I represent in Europe, from Washington DC have moved into India, and there is now a Partnership for Safe Medicines in India. My colleague in the European Alliance at the moment, as I speak, is in Pakistan looking at trying to help people, trying to help the government improve the supply chain there. Very, very, very many more regulators from developing countries are getting much more involved, they’re getting very clever with some of the anti-counterfeiting solutions that they’re implementing.

And for us, the short answer is back to internet – so our next project, our next two projects actually, are web based and are very, very much based on raising awareness and educating people. For the first of the two it’s an extremely big project that’s going to be rolled out in six European countries and the outputs from that we’ll feed into the legislative process. In terms of the legitimate supply chain – it really depends on what happens with the delegated act. Now, delegated acts are a legislative measure that’s really unproven; they’re very new. They almost stalled this piece of legislation because they only came into play after the Treaty of Lisbon, haven’t really been tested but, you know, if the delegated acts process maintains the robustness of this legislation then we’re looking at a very, very strong piece of legislation. It will be very specific and it will be, I think, the first time that we’ll have anything approximating a secure supply chain in Europe.

Pharma IQ: For anyone interested in attending the Pharmaceutical, Packaging and Labelling Summit, what would be your key take home message?

J Thomson: Okay. I think that some of the stuff that I’m going to say will... if people are not up to speed with the legislation it’s going to scare the be-Jesus out them because this has moved faster than anybody thought possible really, and we’re now looking at, at passing into law, in the middle of this year – and they will have two years to comply because this will be adopted by members states within the next 24 months – so for those people listening to this, and if they’re involved in the supply chain they’ll be busily working out that that’s two budget cycles.

So if you’re a wholesaler you’re going to have to be in a position to accommodate this stuff on your supply line, on your processing lines within two budget cycles. If you’re a manufacturer, similar. If you’re a logistics provider you’re part of the game, as well; and if you’re a pharmacist then you’re going to have a whole new piece of software to get used to, and a whole new way of working. RPs are going to have to be trained up, those responsible for pharmaco vigilance are going to have to be trained up – there are massive implications. My take home message is get ready now because two years is not very long at all.

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