Patient groups and the pharmaceutical industry agree that access to medicines needs to be improved but diverge on how best to achieve it. EurActiv.com reports from Sofia.
Severely hit by an unprecedented economic crisis, public health systems in many EU member states are no longer able to fully reimburse drugs, leaving some patients without access to essential treatment.
At a conference organised in Sofia last week by the Patient Access Partnership (PACT), a multi-stakeholder network, several patient organisations explored ways of improving access to medicines and quality of care in Europe, together with the pharmaceutical industry and policymakers at EU and national level.
EU health ministers took timid steps last June to address the rising price of medicines, recognising that in many cases, market failures prevented drugs from reaching patients in need of treatment (See background).
EU ministers expressed particular concerns that the existing complex system of pricing might not be balanced, and that “it may not always promote the best possible outcome for patients and society”.
Member states were encouraged to explore strategies to jointly negotiate prices with the pharma industry, and urged them to exchange information in the phase preceding the launch of negotiations with drug makers.
Many health experts focused on the need to step up regional cooperation between member states, encouraging them to hold joint negotiations with the pharma industry to negotiate access to drugs and prices.
A combination of factors ranging from the major differences in EU member states’ pharmaceutical markets to the various elements and needs of the healthcare systems, have made intergovernmental cooperation a complex issue.
For Stanimir Hasardzhiev, PACT Secretary General, major differences remain but member states, especially the smaller ones, have the political will to cooperate because they know they won’t be able to improve the quality of healthcare on their own.
“We are aware of the fact that the different stakeholders will never agree on topics like the pricing of medicines,” he told EurActiv, saying that part of the solution was to have frank and open face-to-face talks.
Hasardzhiev noted that member states had already started to cooperate, citing several initiatives like the one between Bulgaria and Romania.
Bulgaria and Romania will soon sign an intergovernmental agreement to jointly negotiate the pricing and availability of medicines with pharmaceutical companies, Bulgarian Health Minister Petar Moskov said in an interview with EurActiv.com.
There is already a regional cooperation agreement among the Benelux countries, which Austria recently joined.
These countries coordinate their actions regarding the arrival of new expensive medicines and exchange data. Discussions are also ongoing among Mediterranean countries.
The European Medicines Agency (EMA) will this week publish the much-awaited results of a pilot project on the early marketing authorisation of drugs, EurActiv has learnt.
“These agreements clearly indicate that the current system does not meet the needs of the states,” Hasardzhiev underlined.
“We need a new way that will provide access to patients not only to medicines but to quality healthcare, which is linked to innovative methodologies, diagnostics, and training doctors,” he said.
Referring to the pharmaceutical sector, he said he was “very cautious” in this discussion because it was focused on high pricing.
“I think that the pharma industry understands that it cannot escape this tough conversation. It should stay at the table when we seek better solutions,” he said, adding that pharmaceutical companies have become more open and ready to talk.
Pharma groups are “not defending the argument that everything is fine with prices, because this is not the case,” Hasardzhiev said.
“Burying our heads in the sand”
Yannis Natsis, Policy Coordinator at the European Public Health Alliance, told EurActiv that affordability of drug prices was the major issue.
Referring to regional cooperation between member states, he stressed that such initiatives should send a clear message to the pharmaceutical sector that “the business as usual model is finished”.
“We cannot keep on burying our heads in the sand, and we need to look at the real problems: that the medicines today are in high prices.”
The expert added that the pharmaceutical sector would need its time to adapt to this very new reality in Europe.
“I think they are also having their internal discussions seeing that their reputation is at stake, that the situation in Europe has changed. There is not so much public money as 6 years ago even in the wealthiest member states,” he said, adding that it’s “absolutely necessary” to change their behaviour, and governments set the terms of the game.
In contrast with the member states willingness, Natsis noted that the European Commission’s political “appetite” was low.
“The Commission is too outdated to keep referring to the competence issue,” he said in reference to the exclusive competence of member states when it comes to the pricing and reimbursement of drugs.
“It might not have exclusive competence on health but when it comes to pharma regulation it has a lot of power, through the European Medicines Agency, so they define the different elements that play a role in the question of pricing.”
“Voluntary” for the pharma industry
The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry in Europe, told EurActiv that it would support measures that seek to improve access to medicines for patients.
Elizabeth Kuiper, EFPIA’s Director of European Affairs, noted that Romania and Bulgaria were lagging behind other EU countries on health outcomes.
“One reason is slow access to new medicines, such as in cancer, but there are also many old, well-established medicines that are no longer available in the two countries,” she said.
In an interview with EurActiv last week, Bulgarian Health Minister Petar Moskov said that the intergovernmental cooperation between Sofia and Bucharest aimed to jointly negotiate the pricing and availability of medicines with pharma companies.
Kuiper said that for joint negotiations between Bulgaria and Romania to work “they will have to replace domestic processes for deciding on pricing and reimbursement,” which won’t be easy.
EFPIA also insists on respecting existing agreements on pricing. “They have to be voluntary for pharmaceutical companies (the alternative being existing national procedures), and they have to respect the confidentiality of any negotiated net prices,” Kuiper said.
Generic medicines as “investment”
Adrian van den Hoven, Director General at Medicines for Europe, said that access to healthcare needed to have a holistic approach and urged the member states to focus on generic medicines competition.
“Regarding our off-patent medicines sector contribution, it is now a timely opportunity to engage in dialogue with member states, where there is the opportunity to increase generic and biosimilar competition for access to medicines,” van den Hoven said, adding that the European generic, biosimilar and valued added pharmaceutical industries are ready to support effective measures to best stimulate competition in the field.
A new breed of drugs, called “value added medicines”, could help patients improve their everyday life while in treatment, without increasing healthcare budgets, Christoph Stoller said in an interview with EurActiv.com
“Governments must also see generic and biosimilar medicines policies as an investment in health outcomes for their populations and work to secure a sustainable system for this sector to supply essential medicines,” he said.
Alyna Smith, advocacy officer at the Platform for International Cooperation on Undocumented Migrants (PICUM), focused on migration and EU healthcare systems and said: “For Europeans, anxious about their economic security, facing the effects of years of austerity and cuts to social services, including health care, it is perhaps easy to see migrants as a threat. Regrettably, politicians have perpetuated this narrative, by characterising migrants as carriers of disease, and a potential drain on struggling health systems.”
“But the reality is that, in Europe, people’s migration status often defines their right to access the most basic services. Since 2003, all EU MS must provide basic case to asylum seekers – but even this is not met in many countries. In all but a handful of European countries, people without migration status – including people whose visa has lapsed, women who have left an abusive partner on whom their status depended, who struggle to meet bureaucratic requirements, whose employers profit from their work but refuse to renew their permit – are barred from accessing any health care, besides emergencies,” she noted.
“This means that, in the majority of EU member states, children go unvaccinated, women cannot access routine test for cervical or breast cancer, those who suffer from mental illness or chronic conditions or who are injured on the job cannot except a doctor, unless they go to the emergency room,” Smith concluded.
In June 2016, EU Health Ministers stressed that patients’ access to effective and affordable essential medicines was endangered by “very high and unsustainable price levels, market withdrawal of products that are out-of-patent, or when new products are not introduced to national markets for business economic strategies and that individual governments have sometimes limited influence in such circumstances”.
Member states have the full competence to decide which medicinal products are reimbursed and at what price, while the European Commission is exclusively responsible for the competition of medicinal products on the EU market.
EU health ministers took reluctant steps last Friday (17 June) to address the rising price of medicines.
- Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States