The European Generic Medicines Association, to give it its full name, certainly showed a fine sense of timing in late January with the launch of its five-year plan for boosting the use of generics. It came out with its manifesto just days after the European Commission had announced another round of measures to put the squeeze on innovator drug firms that try to hinder the launch of generic copies.?

The combination of initiatives presents a formidable challenge to the innovative industry at what is already a difficult time. The European Commission, which is the EU’s competition authority, has requested a number of originator and generic companies to submit copies of their patent settlement agreements reached last year.

The scrutiny is a further phase of its bid — conspicuously begun with the pharma sector inquiry it conducted two years ago — to prevent what it sees as anti-competitive deals that delay market entry of generics. The Commission says there are “significant risks” that European consumers are being denied access to cheaper medicines. And it claims that as a result of its actions to date, “potentially problematic agreements have decreased significantly.”

Without question, the effect of the Commission’s interventions, including this latest probe, has been to bring new uncertainties into product life-cycle planning for innovative companies — what the Commission artlessly alludes to as “an increased industry awareness of which settlement agreements may attract competition law scrutiny.”

EGA detects an ally in the Commission, and a soft underbelly in the innovative sector. The EGA five-year plan includes demands for changes to the EU regulatory environment “to deal with the growing demand for generic and biosimilar medicines.” It wants a broader interpretation of the EU concept of the reference product “so as to reduce the unnecessary repetition of clinical studies.” It wants measures to prevent “anti-competitive strategies” aimed at delaying the entry of generics and biosimilars. It wants the EU’s decentralized authorization procedure to be streamlined, with “improved” mutual recognition, and modifications to the centralised procedure to make it easier for generics to access it. And it wants member state medicines agencies to provide information on generic and biosimilar medicines, and to prevent “negative campaigns” against them.

The generics industry is on a roll. Naturally, like many other private enterprise concerns, it wants to increase its market share. But it can argue its case by appealing to a less conspicuously self-interested concept that is now, very conveniently for EGA, all the rage in Europe. The generics industry is arguing that generics “hold the key to healthcare sustainability in the EU.” That sounds like an excellent idea to nearly everyone. Sustainability is a good clean word, and hard to argue with. And healthcare authorities in Europe have been bandying it about for months as if the word itself was a panacea.

Recent debates in the European Parliament and the Council of the EU have repeatedly highlighted its importance and given it almost sacred status.? At the same time, EGA is able to exploit to the full the “Big Pharma bad guys” assumptions that underlie much of the current European debate on healthcare in general and medicines in particular, with more than a following wind from the suspicions so publicly aired by the European Commission’s competition investigations. ?But life is not always simple — and certainly not in the world of European medicines.

The “sustainability” being championed is open to question, because while it may mean “cheaper” (and as far as the EGA argument goes, it certainly does), but over the longer term, if it fails to deliver new medicines too, its sustainability may appear quite different.

Similarly, any assumption that the health of competition (and hence the health of the population) is best promoted by extravagant campaigns focusing on end-of-patent situations should equally be subject to challenge.

EGA is a powerful advocate for its view of the world. The innovative medicines sector deserves equally eloquent representation. All the evidence in the EU at present is that research-based companies are not getting their arguments across. They should.

Reflector, Brussels Correspondent.

Like it or not (and frankly, I don’t), stakeholders are here to stay in European pharmaceutical affairs. Don’t get me wrong. I’ve no objection to democratic engagement, or to giving people with a legitimate interest a legitimate voice. It’s the word I object to. Partly on aesthetic grounds, because it is an ugly coining. But much more because it is one of these words that has now been appropriated by everyone to mean exactly what they want it to mean, irrespective of what it means to anyone else. Consequently, despite its almost mandatory inclusion in every discussion of contemporary pharmaceutical affairs, it has largely lost its meaning.

The upcoming symposium of The Organization for Professionals in Regulatory Affairs (TOPRA) offers a fine example. One of the sessions, entitled ‘Better access to medicines in a changing regulatory environment,’ will look, says the programme, at “the important contribution of all stakeholders” in achieving better health outcomes and improved access. The session will doubtless provide a valuable investigation of some of the genuine challenges identified in the title. But why ‘stakeholders’?

In fact the programme goes on to spell out who TOPRA consider

s as the constituents of this group: “specifically patients, healthcare professionals, academia, pharmaceutical industry, EU institutions and regulatory agencies.” That seems a perfectly reasonable list of interested parties to debate the subject. But when it then indicates that the discussion will cover “the experiences of interaction between stakeholders and working parties at national and EU level,” the question immediately arises as to who sits on these working parties. Not stakeholders, since stakeholders are interacting with them. That — according to TOPRA’s own definition — would rule out patients, healthcare professionals, academia, pharmaceutical industry, EU institutions and regulatory agencies. So what looked like a useful exchange on an important subject is suddenly revealed as an exploration of what can only be phantom working parties consisting of people who have nothing at all to do with pharmaceuticals.

To offer only the most obvious example of the risks to the pharma industry from lazy use of words like ‘stakeholder,’ look at how the term is used by the European Public Health Alliance (EPHA) — an admirable, influential and respectable civil society organization, but no automatic supporter of the pharmaceutical industry. Its mission statement includes the pursuit of “European insti

tutions that are accountable and accessible, policy-making that is transparent and with real opportunities for stakeholder input.”

The stakeholders that EPHA are thinking of certainly do not include the pharmaceutical industry or EU institutions. For EPHA, and many of the other organizations that maintain cautious vigilance over the operations of the pharmaceutical industry, stakeholders are the public, or patients, or consumers, or organizations representing them — not, in other words, the uncritical allies of pharmaceutical companies.

So if the European pharmaceutical industry continues to use the term uncritically, it is at best muddling its message, and at worst playing into the hands of some of its most vociferous opponents. The point is not a simple question of semantics. If the pharmaceutical industry wants to win the battles for hearts and minds that it inevitably and constantly must fight across so many fronts, it is going to increase its chances by being more rigorous in its approach to debate — and it is going to decrease them by sloppy talk.  One stakeholder’s heaven may prove to be another stakeholder’s hell.

Pharm Exec Europe’s EU correspondent Reflector goes so far as to say “Big Pharma is not opening the champagne in public, but it has plenty to celebrate. In fact it can still hardly keep the smile off its public face.”

For 18 months, Neelie Kroes has been assessing whether innovative firms have been distorting competition by illicitly keeping generics off the market. Last week she emerged from her “studious cocoon” to claim that she had found there was indeed dirty work at the crossroads.

But, as Reflector says: “She could hardly say anything else. After kicking off this saga with dramatic dawn raids… accompanied by lurid suspicions of anti-competitive behaviour, she would have looked a little foolish if she had said everything was fine. Embarrassing enough at the best of times. But just months before the end of her five year tenure — the entire European Commission is due for renewal later this year — it would have been even more embarrassing. With no time left to recover her reputation by mounting some other dramatic inquiry into another sector, she would for ever have been remember as the Competition Commissioner who went down in flames because of a bum steer.”

The actual report huffs and puffs about pharma’s attempts to combat generic competition, but there was actually not much reality behind her rhetoric. “All that Kroes did was to wave a 600-page report at everyone in general, and initiate an investigation against a small shoal of tiddlers — Servier and a handful of generic companies,” adds Reflector.

“It doesn’t take long, flipping through the report, to see that the inquiry has dropped the ball. Although it talks at great length about patenting practices and product life-cycle management…it doesn’t reach conclusions that damn outright the industry’s behaviour. There are plenty of expressions of regret at the way the system operates, but on the central questions raised at the start of the inquiry — is innovation declining, and does Big Pharma abuse patent rights to frustrate generic entry — the report says very little, and certainly not enough to identify villains, still less to hang them.”

So, Reflector concludes, it would be imprudent for Big Pharma executives to hold summer street parties to celebrate. But they will certainly be going off on holiday with a lighter heart than they did last year.