Is Europe Creating a Coalition to Combat Big Pharma?


Applied Clinical Trials

The late-June announcement that Ireland is joining the Beneluxa Initiative on Pharmaceutical Policy might suggest renewed vigour for the drive to equip national governments with more clout in their pricing negotiations with international drug firms.

The late-June announcement that Ireland is joining the Beneluxa Initiative on Pharmaceutical Policy might suggest renewed vigour for the drive to equip national governments with more clout in their pricing negotiations with international drug firms.   The Irish Minister for Health, Simon Harris, signed an agreement on June 22 with his counterparts from Belgium, The Netherlands, Luxembourg, and Austria, the current members of this collaborative alliance, set up three years ago with the explicit aim of gaining strength in numbers to tackle the demands of pharmaceutical firms when setting prices, particularly for innovative medicines.   There is no ambiguity in the primary Beneluxa objectives. Dutch health minister Bruno Bruins reiterated them clearly at the signing ceremony: "By joining forces we improve our mutual position in price negotiations towards the pharmaceutical industry and we have a stronger voice at European level", he said. "In this way we can ensure that our patients can count on access to affordable, innovative medicines in the long term”. And Belgian health minister Maggie De Block added: "Four years ago, each country still worked on its own. Today, we are five countries joining forces." Harris echoed their views: this collaboration will assist Ireland "by ensuring that medicines can be sourced at a price that is affordable and sustainable."   Beneluxa-or whatever it will be called now Ireland has joined-sprang from a widespread sense of weakness among health authorities in Europe, crystallized in 2014 when Sovaldi presented them with the epitome of what had been a growing challenge. A steady flow of higher-priced innovative medicines for relatively rare conditions were becoming a chronic headache for managers of health budgets; but the headache became acute with the sudden appearance of a treatment that was demonstratively effective for a huge population, and carried a massive price.   In something like panic, European member state governments cast around for legal instruments they could invoke as a common response. But, hanged by their own rope, they found none, since the EU treaties they had all signed up to excluded common action on questions of drug pricing. They turned instead to voluntary action, joining together in defense on an ad hoc basis. Belgium and the Netherlands were the first to create a formal structure for such cooperation, and this was the genesis of today's five-member coalition. Since then, analogous ventures have emerged. In 2017, Cyprus, Greece, Italy, Malta, Portugal, and Spain signed the Valletta Declaration, a similar but still more limited form of cooperation. Bulgaria and Romania head up another group which is trying to extend its cooperation into other Balkan countries.   However, the results so far have been meagre in terms of constraining drug prices-and the plea that De Block issued at the signing ceremony was more an indication of weakness than of strength: "I hope that other European countries will join us soon," she said, "because the more patients we represent, the more our voice will be heard when discussing high-cost innovative medicines".   Even more revealingly, the attitude adopted by the drug industry is as much one of welcome as of fear in the face of this circling of the wagons by health authorities. Research-based companies see that the sort of discussions that take place within these cooperative ventures can play in their favour, by raising the level of debate, by focusing on value rather than merely price, and even by leading to improvements in the speed or efficiency of reimbursement proceedings in some countries. When Ireland signed up to Beneluxa, the Irish Pharmaceutical Healthcare Association immediately saw the move as a potential lever for easing what it depicted as the logjam in Irish regulatory activity.   Criticizing the "slow and inefficient medicines approvals process for Irish patients", IPHA claimed that "Ireland lags the countries in the BeNeLuxA group when it comes to access to innovative medicines." Ireland is the slowest in western Europe on the availability of new medicines, said Oliver O’Connor, IPHA's Chief Executive, and it needs to make up lost ground.    “Industry and government share a goal to deliver better access to innovative medicines for Irish patients. It is worth weighing any moves, including BeNeLuxA, that can help deliver sustained improvements on the availability of new medicines for patients in Ireland," he said.   Perhaps this slow and diffuse building of coalitions across Europe is more appropriately seen not as a combat between governments and drug firms, but as an ill-defined pathway that could lead to better understanding between all the protagonists as the quality of discussions rises. As Beneluxa points out, its cooperation is not limited to joint pricing negotiations. It also works on horizon scanning, on joint health technology assessments, and on data sharing and policy formation. The likelihood is that better-informed health authorities will be better equipped to confront drug firms. Similarly, drug firms will be obliged to present more cogent justifications for their pricing ambitions-but will at least be able to expect a more sophisticated response from authorities. Ultimately, both sides could gain-and the real winners could be patients.     Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium

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