Posted on Sep 10, 2018
Ushering in a busy period, EU Informal Health Council meetings are being held in Vienna this week, under the Austrian Presidency, with access to innovative medicines and Health Technology Assessment high on the agenda.
The European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) has worked over the summer to agree a compromise deal on medical devices, which the Commission wanted to include in its often controversial proposal of earlier this year.
The issue of the European Commission’s proposals on more EU-wide cooperation in health technology assessment, or HTA, has seen continuous engagement on the topic between the European Alliance for Personalised Medicine and MEPs.
This will continue going forward. Indeed, the European Alliance for Personalised Medicine (EAPM) will host a meeting in Brussels on 26 September to discuss in detail amendments and compromises to the proposal.
Meanwhile, the Alliance says it is actively engaging with Member State Health Ministers as well as European politicians.
At the start of 2018 the Commission put forward its proposal for joint clinical assessment (JCA) in respect of HTA. The proposed Regulation covers new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas.
The plan is that Member States will be able to use common HTA tools, methodologies and procedures right across the EU.
Ensuing events have cast doubt on mandatory aspects of the plans with several Member States (notably France and Germany) complaining that the Commission is over-stepping its remit, given that health is a Member State competence. The Commission also says that the proposal is aimed at improving the functioning of the internal market. This will, says EAPM, be achieved by harmonising the Member States' rules on carrying out clinical assessments for health technologies at national level, and establishing a framework for mandatory joint clinical assessment at European Union level.
EAPM says it agrees with this stance as the Commission’s original proposal has a strong focus on overcoming impeded and distorted market access. The Commission has further stated that the current diversity and multitude of approaches to HTA across the Member States means that, due to their scale and effect, only action at Union level can eliminate obstacles. Without such action, EAPM argues, it is unlikely that national rules on how HTAs are carried out would be harmonised.
In the past, the WHO has said that HTA should be an instrument used to support access to health for everyone, but any action at EU level in the health arena remains a touchy subject for Member States, to say the least. Regardless, the EU institutions are aiming to reach agreement by December of this year, and the European Parliament is scheduled to adopt its position via a vote in plenary long before that.
EAPM is "strongly" of the opinion that what is necessary to improve current circumstances is improved coordination on EU-wide HTA, within a clearly defined framework, which may be difficult to achieve without some kind of mandatory element.
What that would be, exactly, remains a moot point. The Alliance believes that, under the European Union’s social pillar, each citizen across all Member States should be able to have the same access to the best healthcare, often through earlier diagnosis. This is evidently not the case at the moment.
EAPM also maintains that a truly constructive framework for JCA between individual HTA bodies is clearly required to cut down on unnecessary duplication. Striking a balance between a mandatory JCA and a voluntary one looks to be the only option at this stage, and it is up to the Health Council and its members to solve this issue.
Currently there are blockages in HTA decisions which inevitably lead to unacceptable delays in access. The key to the Commission proposal is ensuring that Member States pool their expertise with the help of a facilitating framework and mechanism. But, as noted, there is resistance in certain quarters. Not surprisingly, growing difficulties about patient access have also been highlighted in ENVI meetings (in the case of HTA, under rapporteur Soledad Cabezón Ruiz MEP), as well as at roundtables involving EAPM.
ENVI rapporteur Cabezón Ruiz and others have called for medical devices to be included in any new legislation, although industry has previously strongly said that it wants them left out. Yet it has recently emerged that the ENVI committee is clearly backing the Commission’s original plans, and wants to include coverage of high-risk devices. However, the committee has proposed a longer adjustment period for industry to adapt to new regulations.
Also, the rapporteur is on record as saying that the compromise thrashed out has not aimed to increase the range of medtech included in the original proposal — although this was something Cabezón Ruiz wanted when she wrote her original draft for discussion.
EAPM says, "Perhaps surprisingly, the rapporteur has been quoted as saying that, when it comes to EU-level HTA, speeding up availability is not her priority, she’s more focused on evidence - despite some pharmaceutical companies and patient groups citing that acceleration in access will be a very positive result of cutting out Member States’ duplication on health technology assessment. Other stakeholders feel it will cut down on expensive new drugs that are not much better than ones already available.
"One problem is that, given Member State tension over the mandatory and other aspects of the Commission proposal, should Parliament pass the bill there is still the substantial issue of reaching an agreement in the Council, even though Parliament will likely back the need for it."
In its background notes to the Vienna meeting this week, Austria says that one of the reasons for the growing awareness of the topic of access to innovative medicines is a significant increase in spending for high-priced medicines. Austria says that this increase in spending means that health financing systems are coming under growing pressure to sustainably maintain the high quality of care in Europe.
EAPM goes on, "Well, it is certainly one of the major issues although there are, of course, other contributory factors. The Presidency says that a patient-centred European medicines policy must seek to strike a balance between demand-driven promotion of innovation and ensuring the financial sustainability of health systems. All of this while providing the best possible care for patients.
"Austria is adamant that it is “absolutely essential to develop and implement regulatory measures that are within the scope of health policy” and this is key to this week’s informal meeting."
The gathering will focus discussion on interaction between regulatory mechanisms and other elements of pharmaceutical policy.
“Based on dialogue between market authorisation agencies and health ministries, the goal is thus to identify and implement relevant and concrete measures,” Austria says.
The Presidency has identified four key challenges in European medicines approval: the need to optimise the exchange of information (for example between the European Medicines Agency and approval authorities); strengthening patient benefit of newly authorised medicinal products;
ensuring the availability of innovative therapies across Europe, and; ensuring targeted use of the orphan regulation. Austria details that a key factor in ensuring access to innovative therapies is effective interaction between the regulatory authorities and the payers, or reimbursement authorities respectively.
In recent years, it says, measures have been taken which have significantly improved transparency, for example by establishing accessible databases.
Austria also points out that available studies suggest that “some innovative, high-priced drugs have little evidence at the time of approval and that patient benefit is not well known”.
EAPM states, "There are certainly holes that need to be plugged and responsibility will inevitably fall on any eventual Presidential conclusions in this area, the views of the European Parliament and, of course, discussion and hopefully agreement within the Council."
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