The European Commission will propose a new law on Health Technology Assessments to kick off a busy EU health agenda in 2018.
Health Technology Assessments (HTA) measure the potential added value of a new health technology (i.e. medicinal products, medical equipment, diagnostic and treatment methods) compared to existing ones.
A legislative proposal on strengthening EU cooperation on HTA is expected to be signed off by the European Commission on 31 January.
This is “not a sexy topic”, says Pauline Constant of pan-EU consumer group BEUC, “but it is a crucial tool to ensure that only the medicines with an added value end up on the market.” It has worried EU governments sufficiently for Commission officials to clarify that the EU intends to leave governments in charge of cost-effectiveness and ethical issues.
Through this mechanism, the Commission intends to enhance EU coordination in measuring the value of innovative drugs or medical devices.
Big money is at stake. Depending on the outcome of an HTA, a new drug or treatment could be reimbursed by national health systems. If they fail the test, they might not be.
The EU executive will also publish a communication on Digital Health, also likely to be in March, covering data privacy, mobility and portability of patient data between EU countries.
That is likely to be followed in June by the first digital exchange of health records and ePrescriptions in 9 EU member states, EURACTIV has learned.
Vaccines and the scourge of anti-microbial resistance to them will also exorcise EU policy makers.
In April, a Council Recommendation on vaccines will precede the signature of a framework contract for joint procurement of pandemic vaccines. That will be followed by a report on the ‘Economic burden and health impact of antimicrobial resistance’.
The Commission is also poised to hold a public consultation and summit on health threats from infectious diseases, EURACTIV understands.
Preventative measures, particularly concerning chronic diseases and antimicrobial resistance will also take centre stage, ahead of a meeting of UN Heads of State in New York, in September on chronic disease prevention policies, that will focus on how to meet the Sustainable Development target to cut chronic diseases by 30% by 2030.
“Policy follow-up at EU level is overdue in both areas,” says Renshaw.
For its part, the European Parliament’s environment and public health committee is discussing a resolution on vaccine hesitancy. The first debate in the committee will take place on 25 January.
Funding for health will also be part of the debate on the EU’s next seven-year budget framework – the multi-annual financial framework – that will cover the bloc’s spending from 2021-2028.
“The recently presented top lines for the future EU budget hint that almost all public policies might be subordinated under the single market, ignores the recent good work supporting national health systems and the fact that many urgent health threats (especially drug resistant infections) cannot be solved with national policies but are not ‘market’ issues,” Nina Renshaw, director of the European Public Health Alliance told EURACTIV.
New EU measures on endocrine disruptors are also expected in the second half of the year, EURACTIV understands.
A deal on drugs?
“We are excited by the agendas of both 2018 EU Presidencies, who want to continue the important discussions on access and prices,” Renshaw told EURACTIV.
However, the Bulgarian EU Presidency does not expect a deal to be struck on the long-running talks on drug pricing reform – which began in 2016 – during its six-month mandate. But it is likely to keep the issue on the agenda as it is believed that the Austrian Presidency will revive the talks.
Elsewhere, the EU-US mutual recognition agreement (MRA) on medicines and medical devices comes into force in March.
The Commission is also due to publish a recommendation on leaflets in drug packages – one of the few items which every European has in their home, though equally few ever read them – in November.
“Information should be fairly presented and companies should not be allowed to use them as a marketing tool,” says Pauline Constant.
BEUC will also be “keeping a close eye” on competition in the pharmaceutical sector and access to medicines, says Constant.
The consumer group has been appointed to the Commission’s ongoing anti-trust investigation into whether Aspen had been charging excessive prices for five cancer medicines.