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How much of a hindrance to progress are restrictions on pharma-patient communication, and does EFPIA accept any part of the concept behind parallel trade?

How much of a hindrance to progress are restrictions on pharma-patient communication, and does EFPIA accept any part of the concept behind parallel trade? Director General Brian Ager speaks explicitly to Rob Skelding

Brian Ager, EFPIA Director General, makes an incensed sound. The situation here is wrong and it is a huge frustration, he states, lamenting the current state of affairs prohibiting European pharmaceutical manufacturers from providing information about their products directly to patients.

We are not asking, nor have ever asked, for direct-to-consumer (DTC) advertising. We do not propose that for Europe. What we have asked for is something in between the US situation of full DTC and what we have in Europe today. Somewhere there must be a situation where patients - in fact anybody - can access information on all possible treatment options when they or their families become sick; it's still an information 'pull', and not a 'push' as in the US.

It's a lucid opinion, carved in no small part by the frequent revolution of the debate on patient communications; the familiar merry-go-round on which the industry and its associations have spun time and again.

It just seems so logical, he asserts. In this day and age we think it only right that the European pharmaceutical industry, along with other people such as patient groups, academics and regulators, can give information about drugs directly. How can anybody be against it?

Present restriction in this respect is one of only two topics which incites fervent criticism from Brian Ager in an hour-long interview with PME in early September; unprompted, he actually prefers not to bewail the negative, but rather to enthuse about the positive developments in Europe. The second of his two `negative' topics is parallel trade, which he discusses with frankness a little later.

I think most people see the argument about the current limits on patient communication as being outmoded, especially when they look at it from a patient, rather than industry, perspective - and by that I simply mean the perspective of a human being. If you look at what we want for our healthcare and the information we want about it, it just seems so... he pauses, searching for the precise words, well, you couldn't argue against it. It's irrefutable.

Pursuing this line of argument on a Member State level, however, means the issue quickly becomes more polarised. Yet, EFPIA feels that the `light at the end of the tunnel' is definitely there, albeit brighter in some markets - like the UK and Sweden for example where the local trade association works with the regulators to provide a framework - than in some other countries.

Issues of reputation
While discussing Europe's problems, Ager allows himself to slip only very briefly into something resembling a mildly downbeat manner, each time reclining in his chair, seemingly to consider the scenario philosophically, before re-enlivening himself at the prospect of making progress towards creating and stabilising an attractive European environment for pharmaceutical operations.

One challenge for the European pharma industry, perceived, at least by onlookers, to be significant, is that of credibility and trust; specifically, many feel that there is an unfortunate lack of it. This issue, like that of patient communications, is also well-chewed over, having been debated thoroughly at high-profile meetings around the world in recent years, months and weeks. Pharma has got an image problem, it seems.

In partial opposition to this perceived wisdom, however, Ager questions the perspicuity of the claim. We've given a lot of thought to it and when you actually do some surveys, it doesn't appear to be quite the case. We did it here in Brussels and came out rather well, and we've also had companies assessing positive/negative media reports across the European Union and it's not bad. I'm not actually convinced that our reputation is so close to rock bottom as people glibly say.

The content listings of key conferences around the region reveal that there are perceived to be issues of reputation for pharma to improve upon, yet perhaps the very dialogue itself about how pharma should improve its image forms an integral part of a self-perpetuating, cyclical condemnation. The more profound the debate, the truer the original disparagements appear to become; perhaps such intensive focus on the issue serves to underline its gravity,
or even augment it.

That said, EFPIA has decided to undertake an active programme to try to illuminate to observers the key operations and ethics of European pharmaceutical companies. For some time we have felt that we ought to put more effort into making clearer to the outside world what goes on inside the companies and what we strive to do every day of the week - and not just to the people we usually talk to, such as regulators and government officials, but by reaching out more effectively to society at large.

Ager contends that this is not about `image' per se. That's perhaps the wrong way to look at it, he says. We need to establish ourselves more, and be recognised more clearly, as bona fide partners in discussions about healthcare. We do not want to be in a corner, seemingly unprepared to come out and talk to people, so we keep in contact with other players, like patient groups, European doctors' associations, as well as the media. We also need to talk about some of the positive ideas that we have about improving the conditions in Europe and how the industry needs to be positioned as part of the solution for healthcare provision in the future, and not the problem; that's why we want to be more visible.

EFPIA feels encouraged that the fruits of the proactive programme will help to create a tenable future position from which pharma companies, as partners of health systems in Europe, will incorporate their products as integral to national healthcare solutions; the supplier role may not change, but the plane on which the pharmaco-health system relationship is forged must alter.

We are making a determined effort, but there is a common view in the industry that everybody needs to be doing the same - whether it's EFPIA in the Brussels village or national associations in the Member States, while supported by our companies throughout.

Parallel trade
A journalist will, in most interviews, choose to ask provocative questions of an interviewee purposefully to elicit a frank retort, which is accompanied frequently by a `stream of consciousness' on a key issue of debate. This simple process incites the speaker to formulate and eloquently articulate a rigid argument to which they adhere resolutely and in which they believe ardently. For Ager, such a case is the practice of parallel trade across Europe.

It should be stopped, he states directly, without hesitation.

The fight has been going on for a long time and, personally, I think it is time for some serious discussion on what can be done about it.

He makes his position very clear: We argue very strongly that it is a failure for the European economic situation. It is a waste and, by and large, the benefit goes to the dealers. It doesn't go back to the industry or into social security systems and it has the potential for confusion and safety concern.

The turbulence between parallel traders and European drug manufacturers blows hot and cold. Right now, it is high on the agenda for discussion.

Does Ager oppose the very principle of parallel trade, even when pharma turns a good profit and still enjoys a high level of spending in research and development, or are there specific activities which he feels are not right?

Parallel trade is a normal phenomenon in the functioning European market, which is a market driven by normal economic parameters such as selling watches, tables or other consumer goods. Fundamentally, it is correct and proper in such a market. However, when you have government control over prices, as in healthcare, then it does not apply because it is impossible for the industry to adjust to it. 2004's losses are estimated at Ä4.2bn.

There is also the disruption damage, he adds. If the stock you had organised for Spain suddenly disappears, patients and wholesalers are screaming and you have significant disruption to supply, which also brings potential difficulties if you have to recall a product, or get into a safety situation. It isn't sensible by any normal standards.

Where does EFPIA stand on the suggestion that parallel trade allows criminal counterfeiters to wreak havoc in Europe's markets? It's difficult to pin it down. I'm not saying that one automatically follows from the other, but the more grey market you have, the greater the opportunities for unscrupulous operators to get in. [For more on this issue, read the debate starting on page 28]

Future positive
Sharpened opinions on the issue of patient communications and parallel trade aside, Ager does not actually appear to be overly agitated. He is not a natural agoniser. Quite the converse, in fact, he exudes a positive outlook and is more enthusiastic about developments in Europe than he is cogitative about its problems.

The new Innovative Medicines Initiative (IMI) is a robustly positive topic. In short, this is what Ager describes brightly as our cunning plan to heighten the attractiveness of Europe as, in the most uncomplicated sense, a region that lures, drives and rewards innovative R&D.

This is our chance to be ahead of the pack, he enthuses, depicting the IMI as a cluster of public-private partnerships (PPP) that aim to maximise scientific progression and translate it into applied R&D to the benefit of pharma firms. The idea being that a PPP group in Europe, which might include a university, a couple of biotech start ups and several pharma companies, takes a section of pre-competitive research and drives it forwards.

It will benefit everyone, he adds, becoming more animated by the second. We've got the agenda, we just need the green light.

2nd September 2008

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