- The problem stream
- The policy stream
- The politics stream.
“There is an alarming increase in the EU of medicinal products which are falsified in relation to their identity, history or source. […] They pose a major threat to European patients and European industry and there are strong concerns in the public and amongst policymakers about the steady increase of these products detected in the EU in the last years.” 
3.1. Problem Stream
“We were on this issue more on the push side […]. Basically we proactively put the issue of anti-counterfeiting on the table.” (Representative of brand owners’ interest group)
“We were in some way linking parallel trade with counterfeiting. But we were more making the issue that parallel trade was potential entry points for substandard medicines into the supply chain. […] We went not in the press with all these negative examples about parallel traded products at the time. But we did collect this and it was very important evidence in order to get the issue really on the top of the Commission’s agenda.” (Representative of brand owners’ interest group)
“Sometimes I would even personalize it. I said ‘How about you? I am sure you are taking medicines. Have you any idea where it is coming from? Or what quality it is?’ And they look at you strangely. I said 'And what about your... Have you got any grandchildren? Or you got any elderly parents? Yes?” (Representative of API manufacturers’ interest group)
“It was quite clear that 95%, 96% if not 99% of all the falsifications are in the so-called internet circuit, rather than in the normal chain of logistics to deliver the goods, the medicines, to patients. So we argued in those days that by introducing this system we did not really approach or tackle the root cause of the problem, which is the internet.” (Representative of generic manufacturers’ interest group)
“It’s quite difficult for us to oppose strong patient safety measures inside our core business. […] We took a decision not to kill it or try to kill it, which we would never have succeeded in doing anyway. We played along with it and we tried in the subsequent seven years to shape it, which we have done reasonably successful[ly].” (Representative of pharmacy’s interest group)
3.2. Policy Stream
“So most of the measures that you find in the Falsified Medicines Directive were... or some of the provisions were on [our] shopping list. But it was not articulated the way the directive did at the end.” (Representative of brand owners’ interest group)
“So we were even proposing to increase the rules—to make the requirements and the criteria stricter. […] But then you get into the competitive area […] where we as association have to be very careful.” (Representative of wholesalers’ interest group)
“I am thinking ‘Hang on a minute. Are you European? Are you supposed to be helping European industry? […] Why are you not wanting to help people who are operating in Europe, who have been made to suffer competitively, because of the lack of enforcement of legislation? Why would you not want to help them improve their competitiveness?’ Let's just leave it at that. And eventually [they] did. And every bit of—I think it was our second or third position paper—[they] put into the pot, and then [they] told us that an impact assessment was being done on something that was going to be called the Falsified Medicines Directive or whatever the euphemism was at the time, and it would all be taken into consideration.” (Representative of API manufacturers’ interest group)
“Our response to that consultation was […] shorter and less detailed, because we had less to say, in the sense that counterfeit is illegal by definition.” (Representative of consumers’ interest group)
“When you repackage, by necessity you must remove these safety features. And the directive says you can remove the safety features on condition that you do that with the approval of the brand owner. Now in our business, the brand owner would certainly never approve.” (Representative of parallel trade’s interest group)
“It’s clear that we wanted also to act in some way on parallel trade. [...] and I can share with you the response at that time we did to one of the public consultations. I think that the only sentence was that ‘the Commission is applying two sets of standards: one for (parallel traders) and one for (brand owners)’. And this is what we have been demonstrating, why we wanted a ban on repackaging.” (Representative of brand owners’ interest group)
Interviewee: “[Brand owners] initially approached us way back in 2006, 2007 about setting up a system. And we went to a couple of meetings with [brand owners] and then we withdrew.”Interviewer: “For what reason?”Interviewee: “Because it became clear at the time that what [brand owners] was interested in was the data. Dispensing data. Which was a big issue [...]. So we thought 'Well, this has no interest for us”. […]Interviewer: “They used counterfeit medicines as a sales point here?”Interviewee: “Well, I can’t put words into their mouths, but currently the industry spends a lot of money on getting data, sales data for products. And there was undoubtedly a view held by some people—this was never said publicly—that the […] system could be used to harvest that data. Which is true: it could be used to harvest that. […] Well, I mean pharmacists already do sell data. But what they do is, they sell sample data. Which isn't as comprehensive as it could be. And they sell it for little. So there is a data business to be had. Although no one... It's a bit of a taboo to talk about it.” (Representative of pharmacy’s interest group)
“So for me it is one of the best projects that we have been working on at level of this organization over the last two decades. It's something […] that people still underestimate the potential impact. Just because we want to use the system beyond […] its pure objectives.” (Representative of brand owners’ interest group)
3.3. Politics Stream
“We lobbied against Verheugen’s initial proposal, and we [asked our members] to write letters to their national commissioner. We provided them of course with templates through our agency. We asked for meetings. We were granted meetings. I joined one in the cabinet of the Portuguese president at the time. One with the French commissioner’s cabinet. The Italian. And also one of the Baltic states. And Mrs. Wallström from Sweden. And there was an Irish commissioner as well. And a couple of commission or cabinet experts, who understood the matter and could clearly see that this was not legal […]. They were probably a little more liberal minded also given their commissioner’s position. They were quite supportive inside the Commission to help us spread our message. In the end, we were told that 17 commissioners voted against Mr Verheugen’s proposal when he brought it into the Commission. […] We as parallel distributors had won an important step in the fight against a directive [that] was biased and would have clearly stopped our business.” (Representative of parallel trade’s interest group)
“With respect to counterfeit products traded inside the Community DG ENTR essentially seems to rely on three instances where these products entered into the legal supply chain. […] We would still believe that further fact finding would be very useful and indeed necessary. Otherwise, it remains difficult to assess the gravity of our common concern on counterfeit products. It is also difficult to identify the appropriate measures to be taken.” (Document from inter-service consultation of the European Commission sent by DG COMP to DG ENTR)
Interviewer: “Did you before 2008 lobby for counterfeit medicines to come on the agenda?”Interviewee: “No, I don’t think so.”Interviewer: “Why not?”Interviewee: “No, I... I think it was... Yeah, it was not something that was felt strongly about from our members.” (Representative of consumers’ interest group)
“I know that only two companies will put anti-counterfeiting among their top five priorities. Two companies!” (Representative of brand owners’ interest group)
“So now you’ve got lots and lots of more legislation, some of which is still being awaited to come to fruition. Yeah... In some ways it’s very sad. In other ways, we were partly successful. So... I guess that's the bottom line for me.” (Representative of API manufacturers’ interest group)
“Without seeing the real numbers [of falsified medicines], and addressing the real problems, you could say that policymakers chose to overreact, producing a proposal for a directive which has long-term implications for all distributors in the supply chain. […] They are pragmatic and logical, and certainly would add a level of security to the supply chain, but ultimately you have to look really down into where the problems are, that is, the unregulated channels. This does practically nothing. Yeah, something but practically nothing to address the unregulated channel.” (Representative of wholesalers’ interest group)
“I told my government that we will have to adjust our prices once this is in place, and they said ‘Oh, how much is this going to be?’” (Representative of generic manufacturers’ interest group)
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