European Alliance for Personalised Medicine
No stopping on journey towards equality in access to medicines
By European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan
The importance of access to medicines and innovative treatments for Europe’s patients is undergoing particular scrutiny at the moment and will be a big issue in the European institutions this year.
Indeed; on 11 February, Parliament held a discussion on access to medicines, following a statement by the Council and the Commission.
As well as its Working Group on Early Access and Better Decision Making, the European Alliance for Personalised Medicine also hosts an MEPs’ Interest Group, formed as a result of EAPM’s ongoing STEPs campaign. The Alliance has been in continuous dialogue with members since its formation, on access and many other topics, and MEPs certainly had plenty to say about the issues at the plenary.
Prior to them speaking, they heard Latvia’s Zanda Kalniņa-Lukaševica, President-in-Office of the Council, state that “access for patients to medicines that efficiently treat illness is an important issue that must be addressed both at national and EU level”.
”It involves several aspects,” she added “namely: availability – meaning that new medicines are developed or existing products are adapted; also accessibility – bringing the products to patients who need them. It is also about affordability – ensuring that patients, health-care providers and governments can afford the products; and lastly, ensuring quality so that the medicinal products work as intended and are efficient and safe.”
She flagged up the fact that, at the December Health Council meeting, conclusions were adopted on innovation for the benefit of patients, inviting Member States and the Commission to expand their work in several areas.
Not surprisingly the Minister also highlighted the creation of the Expert Group on Safe and Timely Access to Medicines for Patients (STAMP), which began its work in January.
At the same plenary, Christos Stylianides, Commissioner for Humanitarian Aid & Crisis Management, explained that a strategy on EU cooperation on health technology assessment was adopted in October last year.
EAPM welcomes these initiatives, but maintains that they are not enough. Among the basic tenets of the EU are equality and access to the best health care for all, regardless of who or where they are. This is clearly not the case.
Plenty of MEPs aired their views later. For example, Kostas Chrysogonos acknowledged that, in recent years, health has been a major target of cuts in expenditure.
Meanwhile, Cristian-Silviu Bușoi, who will speak at an EAPM workshop on 25 February, explained that despite the existence of innovative new drugs, new technologies and developments in medical science, many citizens are not able to access them, often due to high costs. Other issues include overly bureaucratic reimbursement procedures and a lack of implementation of the Cross-Border Health Care Directive.
Bușoi believes that EU policymakers should ensure that regulatory decisions on the value of innovative therapies are based on what matters most to patients, and ensure that they get access to innovative treatments following a centralized cost-benefit analysis by the EMA.
Julie Girling, meanwhile, reminded her colleagues that pricing and reimbursement of medicines within the EU is a member state competence. She added that it is the responsibility of the individual mmber states to use their bargaining power to keep these costs as low as possible.
There were many more comments and there are many complex issues, and It is undeniable that new targeted drugs and treatments can be expensive. But EAPM believes that the European Commission needs to do, in tandem with the Parliament, is to create a regulatory environment which allows early patient access to novel medicines and treatments.
A close scrutiny of, and changes to; the current system for incentives and reimbursement, for example, may represent a very solid start.
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