Brian Ager is departing director-general of the European Federation of Pharmaceutical Associations and Industries (EFPIA).
EFPIA represents over 2,200 European pharmaceutical and biotech companies, including Bayer HealthCare, GlaxoSmithKline and Pfizer.
He was speaking to EurActiv's Craig James Willy.
There is concern that the EU-India free trade agreement (FTA), and in particular the application of intellectual property legislation, will limit the ability of Indian industry to produce generics. There have been protests in New Delhi and other Indian cities, including by HIV positive patients. What would you say to address the concerns of those protesters?
I would say they have absolutely nothing to worry about. There's no way that anything in the India-EU FTA could or should have any impact on Indian generic companies being able to supply the developing world or their own country with generics.
We've made it clear publicly that we're not supportive of anything that would damage that ability and the Commission has done likewise. For us it's not a 'real issue' and shouldn't become an issue.
There were similar murmurings before India passed its 2005 Patent Act. I think MSF [Médecins sans frontières] and Oxfam were expressing very worried opinions about the same thing and it didn't come to pass.
The real problem in India and in Africa is poverty, and intellectual property rights have nothing to do with that.
The new intellectual property rights of the FTA would not retroactively apply to old drugs but they could apply to new drugs Europe researches. Indian industry would not be allowed to produce new drugs that Europe researches.
IP protection is asked for in these FTAs because once you've got a good intellectual property system in place you are able to protect the new product. Secondly, you're encouraging, particularly in India's case, the very successful generics industry, to also think about doing some research. Why not? They've got brilliant scientists, great chemists, software engineers…
If they've got a good and enforceable intellectual property system in place you can see India building on what it does so well already and starting to get into the R&D race. This would be fantastic and it would encourage investment from our type of companies over there. It's positive all round.
What are your thoughts on the passage of the Falsified Medicines Directive?
We've always been supportive when the Commission started to think about it. We encouraged them to do so. We really wanted to put a system in place that makes counterfeit drugs impossible, not to limit generics, 'real' counterfeits.
Overall in terms of the text, we're pretty comfortable with what's come out of the sausage machine. Now the attention has to go to delegated acts the Commission is allowed to put in place on its own. There's quite a lot of work to be done there.
We are very interested in seeing one pan-European coding serialisation system. The vision there is that every pack would have on it a 2D barcode to be read by the pharmacist when you get your prescription. This can verify in a nanosecond the authenticity of the pack.
There have been scandals in recent months regarding the safety of certain drugs in Europe. A report by French health authorities suggested that the anti-obesity drug mediator (benfluorex) has led to the deaths of 1,000-2,000 people. A study by the Finnish National Public Health Institute found a "likely causality" between the H1N1 flu vaccine Pandemrix and narcolepsy among young people. What is the pharmaceutical industry doing to address the health risks of drugs and is the industry worried about loss of public trust?
We're always worried about trust. Not commenting on any particular cases, which is outside my bandwidth, we were encouraging the Commission to do what they've now done, which is to put in place a new pharmacovigilance regime. Just before the Falsified Medicines Directive went through there was a new pharmacovigilance legislation pack. It tightens up the system throughout the whole of Europe and we are fully supportive of that.
The head of the European Medicines Agency, Thomas Lönngren, has left that role to work for a lobbying firm for drug companies called the NDA Group, as well as joining an Australian biotech company. What do you think about this and issues of conflict of interest between regulators and industry?
I don't know the specifics of Lönngren's case. I don't know what the rules are. There probably are rules. I'm not aware of them and I've not searched to find out what they are. I think if there are rules they should be followed. Whether Thomas has fallen afoul of that I have no idea. You may need to ask the Commission that.
After sixteen years at the head of EFPIA, what would you say you are most proud of having done?
I think over that time we've seen a lot of improvements that we've been associated with. We're not the regulators but we're involved in asking for things and advocating for things, and the list I think is rather positive.
I can look back on things which I think moved the needle, in the sense of things that are in place that weren't in place 15 years ago, things that helped R&D and innovation. That's really the goal that we have as AFPIA. We want Europe to be the best place it can possibly be for attracting science, innovation and R&D. And not losing the race to our American friends or in the future to our Chinese and Indian friends.
What might those be? The construction of the EMA for a start. That opened its doors the year I started. That was a very important step. Before that you had national authorisation and mutual recognition. From then on the companies could go to one place and get a market authorisation for the whole of the European Union. That was a big step forward.
We've seen biotech patents put in place. Before 1996 you couldn't get a patent on a biotech product, a big step forward. There's also paediatrics, orphan drugs… There's a good list.
If you could choose one?
I think the biotech patent. That was the biggest one. And it failed the first time round, two weeks after starting this job I had to put out a press release regretting the fact the European Parliament had kicked it out of the window. The Commission had another go at it and we supported them. And we did our best to explain to parliamentarians, perhaps in a way we didn't do so well before, what it means. The Green movement was doing nice, simple slogans like "no patents on life".
The thing I think was important for EFPIA was getting companies in. When I started EFPIA was an association of federations. We had no company members. I actually played a big role in changing that in 1997. From then on you saw a much greater attention on what we do from chief executives, which puts a lot of pressure on the system of course and a lot of pressure on us.
But you need that, if I'm going to go to you as a journalist or anybody else and say "I represent EFPIA," they'll answer, "Well, who are your members?" It's the British association, the French association, but what about the pharma industry? You guys are all the industrial civil servants but where are all the big shots? Having them on board was something I thought was really important for EFPIA's future and its ability to say in a genuine way that it represents the upper echelons of the industry.
Now you see our board meetings are populated by a good dozen-plus chief executive officers and that's important. I think otherwise it might have withered on the vine.
And also, if you want to go to a commissioner and have a point to make, if you can take a CEO, chairman of company, that has a lot more clout than me going. I can say the same words but hearing it from someone who maybe employs 50,000 people in the world, has a research force of 12,000 or 15,000 people and makes investment decisions every month, has much more clout. I was very pleased to get those guys to supervise us.
One last thing, we searched for a long time to find a way in which we could better harness the brilliant scientists in our universities in Europe with our scientists, also brilliant, in the companies. It became a kind of Holy Grail seeing what the Americans had accomplished with the NIH and the NCI and so on, big federally-funded machines which can churn out basic science for everybody to use.
We couldn't fathom how to propose that we construct that in Europe. We did, finally, working with DG Research come up with this European version of that which is the IMI, the Innovative Medicines Initiative, that's also great and something I'm really proud of. Because it should over its lifespan of seven or eight years line up scientists in academia and in industry in dealing with those bottlenecks that stops us being as efficient as we should be. Plus spin off benefits! If we come out of that with a reversal of the sense that young scientists need to be in California or Massachusetts. Why not be in Heidelberg and Cambridge and Montpellier instead? That would be fantastic.
What advice would you give to your success on the challenges that the pharmaceutical industry will face?
Listen to what the leaders of the industry say. Make sure you're close to that. Be resilient. Why? Things in this town take a long time. You can't get something changed in a year. IMI took us collectively – Commission, Parliament, the Council, with us egging them on – probably four or five years from conception to output. Last year we managed to see a revision of the Laboratory Animals Directive. An old directive, the Commission says we're going to dust it off and make a new one. It took seven years from conception to the final passage of the new directive. The biotech directive collapsed once, so that took something like fifteen years.
So you're in it for the long run. That does mean you need a sense of vision too. What is it you want to see? I think the guiding light to me is being able to identify and pursue things that will help Europe. It's not just the industry. The infrastructure for innovation and research in Europe, that's the light you need to follow.
These things take longer than any one Parliament or commissioner.
It's tough for them because each commissioner comes in and says "Now I want to do something new and different". Now we've got [Commissioner for Industry Antonio] Tajani and [Commissioner for Research Maire] Geoghegan-Quinn talking about "healthy ageing", the "Innovation Union", "Europe 2020", all that kind of stuff. Now you've got that, that sounds wonderful, but what are you actually going to do? Are you ready for it? Are you up for it?