Is This When the Drug Industry Starts a Fight-Back?

“You wanna play rough? Just try it!” was the gist of the New-Year message from the European pharmaceutical industry to the healthcare authorities circling menacingly around drug firms preparing for pricing discussions.

The industry has for half a decade been at the sharp end of growing pressure to bring its prices under control, led by European governments with budgetary problems, and with enthusiastic support from many paying agencies, patient groups and civil society organizations. Some countries despair of being capable on their own of countering the negotiating power of big drug firms brandishing exclusive innovative medicines, so they have started to explore joint approaches in a bid to boost their collective power.

“The noise around cross-country collaborations on access to medicines has been constant”, commented Nathalie Moll, the new EFPIA director general, as she launched a carefully-considered warning to any of these coalitions aiming to force down drug prices. Faced with this wave of joint international initiatives, EFPIA has delivered a firm ultimatum: drug firms will cooperate with any such new schemes only if they believe they are fair and will ease patient access. Moll left it in no doubt that her members will “draw the line between acceptable and non-acceptable practices”.

She specifically cited the BeneluxA-I scheme in which five countries now cooperate, as well as the Valletta Declaration group of mainly southern European countries and the Scandinavian collaboration among Finland, Norway and Sweden. They “collaborate on concrete projects, such as health technology assessment, public procurement, horizon scanning or price negotiation,” she pointed out. But she widened her reflections to a broader generalization about any such schemes: “New processes, new structures, new systems to manage the introduction of new medicines need the companies that research, develop and deliver those medicines to engage.”

Moll, who has won new admirers across Europe for her personal charm since she took up her post, is increasingly demonstrating that her velvet glove conceals an iron fist. “Cross-country collaborations on access to medicines are perhaps at a crossroads across Europe today. Either they deliver on their initial promise or they run the risk of fading away,” she said.  In other words, play fair or we don’t play - and without us, you haven’t got a game.

EFPIA has set out what it calls “a number of policy and structural issues” - principles that it says should be addressed in the design and operation of collaborative schemes, because “there is little successful experience of enhanced access driven by these initiatives.”

Joint pricing negotiations “should have a long-term objective of broadening access for patients and stimulating the medical innovation that patients need,” it says. “That means not using them solely for short-term, financial cost containment goals achieved through the negotiation of the lowest price.” The value of innovative medicines, measured through actual outcomes and benefits for patients rather than financial interest, should be the basis. Companies will also need to be sure there are solid legal frameworks and legal predictability, particularly on confidentiality of net prices and commercially sensitive information.

Any moves towards joint public procurement should be limited strictly to “where it can improve access to patients to treatments”, and where product supply cannot be ensured as efficiently by individual purchases country by country. “Its use should not become a disincentive for innovation”, says EFPIA. And company participation should be voluntary in nature.

The same should apply to HTA, which countries are experimenting with as a joint exercise, says EFPIA: “If a company believes that participating in a cross-country collaboration pilot will delay or prevent access for patients then they should retain the right to introduce the medicine through the national procedure.”

“Don’t push us” is the sub-text of this industry warning. EFPIA concedes that there are potential synergies in some areas of cooperation, such as supra-national horizon scanning or the creation of joint patient registries. But it wants no new squadrons of tanks placed on the lawn of pricing. If the objective of the collaboration really is timely and optimal access, then the specific local socio-economic circumstances of each country and healthcare system have to be taken in to account - and “this can only be achieved by maintaining economic value assessments and pricing negotiations at national level.”

“Industry’s overall priority is that any cross-country collaborations contribute to better access for patients,” concludes EFPIA. New schemes should not create duplications with existing access policies and measures, because that would result in undue delays, it says. And “in the absence of adequate measures to address these gaps, national access processes will remain the most efficient tools to guarantee timely access for patients.”

The industry’s outspoken fight-back was immediately met by an equally candid push-back. “These are interesting principles”, responded the European Patients Forum icily, “but we would like industry to engage with the problem of health system sustainability. Ensuring access for patients means drugs must be affordable, too.” EPF’s position is tightly focused on patient need, with industry demands well down on its list of priorities: “There is an urgent need to identify effective and concrete actions at EU level to close the current gap on health inequalities, so that all patients across Europe have access to high-quality, affordable treatments,” it says.

Kaisa Immonen, EPF’s director of policy, added an encouragement to industry to go beyond its insistence on the conditions it has set out, and engage with the same degree of commitment to the concept of affordability - “something I see missing in the value-based healthcare discussion.”

A senior official in the European Commission’s health department, Sylvain Giraud, similarly remarked on EFPIA’s “interesting principles”, but went on to speculate: “Why should anyone be afraid of cross-country collaboration?”, especially in the EU, where it can “probably aim at improving the sustainability of health expenditure”.

Moll countered that EFPIA is not “afraid of cross-country collaboration”, but conditions its support on initiatives being able to deliver faster, wider access to new medicines. “The principles are designed to help reach that shared goal,” she added. But stepping into the ring of public - and often hostile - debate is likely to provoke some even more trenchant comments on the EFPIA stance.

One of Europe’s most voluble civil society figures in the healthcare debate, Yannis Natsis of the European Public Health Alliance, was quick into the fray. “Pharma is worried its divide and conquer policies are defied by EU governments who have finally woken up to realize they have leverage, and are at last getting their act together.” He suggested the “rather inappropriate” tone of the EFPIA principles betrays “pharma’s discomfort and fears” about “game-changing” cooperations - which, he claimed, are “a direct consequence of pharma’s aggressive pricing and business strategies that put patients’ lives at risk.”

It won’t be long before these relatively mild criticisms find their echo, and the industry fight-back will then be truly underway.