BRUSSELS, 16 Nov (APM) - One of the leading healthcare payers' organisations in Europe has called for tougher controls on drug pricing and tighter limits on awarding of incentives to drug developers.
AIM - which represents mutual insurance organisations - presented a bold manifesto for the coming five years, with the backing of European health commissioner Vytenis Andriukaitis.
The commissioner endorsed the manifesto, saying "the engagement of stakeholders like AIM is fundamental. Together, we need to ensure that health and social protection are at the very top of the European agenda."
The manifesto is broad in scope but light on specifics (with its principal claim being for a bigger role for payers), but it will carry weight because AIM is one of the most prominent payer organisations in European health policy.
Its impact on current European discussions on pricing, incentives and access will therefore be influential in strengthening the voices calling for closer scrutiny of the drug industry.
AIM said it wants political commitments to an ambitious political agenda for reviewing the incentive structure in the pharmaceutical sector, in a message explicitly delivered to the European Commission, Parliament, and Council, all of which will be renewed to a varying extent next year.
"The current system needs to be improved if it is to stimulate development of urgently-needed pharmaceuticals while simultaneously contributing to affordable access to pharmaceuticals for all," it said.
It favours increased EU collaboration, which, it says, can "greatly assist member states in their efforts to strike a balance that meets the interests of all stakeholders in such a way that ensures sustainable access to high-quality pharmaceuticals for all EU citizens."
The EU should "place the interests of citizens at the centre of its actions."
AIM wants Commission, Parliament and Council "to be involved in assessing the complex and detailed system that leads to market exclusivity."
Costs and access
The review should extend beyond intellectual property and market exclusivity and cover marketing authorisation, health technology assessment and pricing and reimbursement.
The AIM calculation is that drugs and devices consume 20-25% of healthcare expenditure, so "they must be managed carefully."
It repeats the familiar claim that "costs of newer medicines are becoming a challenge for more and more EU member states, endangering solidarity-based access to healthcare."
It also questions the merits of many products. "While the prices are high, the true added value of these medicines is sometimes unclear at the time market authorisation is granted."
High-quality medicines should be accessible for all, it insists.
Its recipes include "strengthening methodologies for (relative) cost-effectiveness studies and transparency", particularly covering "decision making, managed entry agreements, reassessments and appropriate use."
And "the European Commission should facilitate exchange between member states on pricing and reimbursement practices". Actions "should help member states ensure fair prices so that all their citizens can access the pharmaceuticals they need."
Noting the importance of the European Medicines Agency in the market access process for new pharmaceuticals, AIM stresses the need for the agency to execute its role independently.
But it wants to see closer links between the agency and other responsible authorities, including itself: "It should not work in isolation, but rather should maintain regular dialogue with organisations undertaking health technology assessments, pricing and reimbursement decision makers, and healthcare payers."
AIM sounds a note of quiet concern over current EMA reflections on adaptive authorisation and other more flexible procedures for pharmaceuticals with promising potential impact on high unmet medical needs.
The mechanisms that the agency is developing to balance early market access and actual safety and efficacy "need broader political discussion", it says.
AIM also welcomed the European Commission’s proposal for a regulation on HTA, and insists that it should cover devices as well as drugs.
But at the same time it rejects any joint HTA procedure that might "infringe or contradict the national responsibility of health systems."
This requires allowing joint assessments to be "where necessary, complemented by further assessments nationally."
And payer organisations have to be involved in further developing the proposal: "The regulation should ensure that payers have an active role in HTA at European level."
Recognition for innovation
AIM is not hostile to health technology as such: "Pharmaceuticals and medical devices play a vital role in the treatment of diseases", it acknowledges.
These industries are also "an important economic sector within the EU and worldwide."
So the EU should recognise the interests and impact of these industries.
EU institutions "can contribute to better public health and a more resilient and accessible healthcare system through a robust healthcare innovation agenda," it says.