The country is tasked with trying to wrap multiple tricky health files before May’s European election.
The to-do list facing Romania looks tough.
The country took over the rotating presidency of the Council on January 1 and Health Minister Sorina Pintea said she is “equally realistic and ambitious” about what can be achieved on health issues in the coming months.
“Realistic because we understand that ours will be a transition presidency,” Pintea told her fellow EU ministers at the Health Council meeting in December.
With the European Parliament election in May, Romania faces a time crunch to make progress on a range of files that will otherwise likely go on hold until the new European Commission begins work this fall.
Pintea said progress under Romania’s watch will “rely on a collective effort and a strong political will” in both the Council and the Parliament.
But countries’ reluctance to see the EU intrude on national health systems will make it tough for Romania to break Council stalemates on several files, including plans for the EU to have a say on the value of medicines and new rules for manufacturing drugs under patent for export.
1. Health technology assessment
EU countries are heavily split over the Commission’s proposal to join up assessments on the value of medicines.
The major impasse centers on whether national governments should be forced to use the results of the EU-level scientific assessments without conducting their own.
A handful of countries with enough power to block the proposal, including France and Germany, are balking at the possibility of having to cede authority of their national health technology assessment (HTA) bodies. Other countries (and the Commission and Parliament) say the exercise would fail in its mission to eliminate duplication if it’s not mandatory to consider the EU-level results.
There was consensus among national officials this time last year that if the Council couldn’t decide on a common position from which to begin negotiations with Parliament during 2018, there was no chance of an agreement before the May election.
Pintea said the Romanian presidency wants to “make as much headway as possible and reach a general approach,” which would form the Council’s position for talks with MEPs.
Brussels wants to allow generics and biosimilar producers to manufacture medicines for export that are still under patent protection. Countries are divided over when that manufacturing waiver should enter into force and whether it would apply to existing supplementary protection certificate (SPC) rights.
The Romanian government showed its hand during the Health Council in July, when the country backed a call by Hungary to allow for a speedier application of the SPC waiver.
“Our objective is to work towards a reasonable compromise that would allow us to reach an agreement in the Council and get a mandate to start negotiations with the [European Parliament] in due time,” spokesperson Raluca Anghel wrote in an email.
The Parliament is expected to vote on its position in committee in January, which would increase pressure on the Council to reach a negotiating position in the Competitiveness Council. The Commission and countries in favor of the waiver want it signed off before the election, but that outcome would require swift progress.
“There are only a few meaningful weeks to conclude this file under the current legislative term. The Romanian presidency intends to make the best of this limited negotiating time,” Anghel said.
Romania’s aim: Council negotiating position
Chance of success: 50/50
3. Antimicrobial resistance
If Romania walks away with one presidency win, it will most likely be a set of conclusions on how countries can work together to tackle antimicrobial resistance and associated infections. That document is tentatively scheduled for adoption at the Health Council on June 14.
Romania will also host a ministerial conference in Bucharest on March 1 to discuss the issue, which the European Centre for Disease Prevention and Control estimates is killing up to 33,000 people a year. “One of the main objectives will be to advance a discussion on the common approach of the human, veterinary and environmental sectors,” Pintea said.
The main drivers of infections are the overprescription of stronger broad-spectrum antibiotics, as well as prophylactic antibiotics prescribed before a surgery. While the EU has adopted new rules designed to phase out prophylactic antibiotics in farm animals, any move to limit their use in humans is much trickier since prescribing rules are up to each individual country. It remains to be seen whether Romania can get EU countries to move beyond shared guidelines and agree to more stringent limits.
Romania’s aim: Council conclusions
Chance of success: High
4. Access to medicines
Romania “will continue the strategic debate in the Council on patient access to … affordable innovative medicines and therapies,” Pintea said.
The Austrian presidency in September put forward several ideas on how to rein in drug prices and improve access, with countries like the Netherlands expressing support for options such as a stricter time-limit for centrally authorized medicines to be available across the EU.
Romania will bring its own experiences to the table following the country’s recent shortage of immunoglobulins for treating autoimmune disease. Pintea said she particularly wants to address the issue of rare disease patients to help them gain access to “treatment available in other member states if that treatment is not available in their own [country].”
Romania’s aim: Exchange of views
Romania will take up the mantle for efforts to get EU countries to boost vaccination rates. Under the Austrian Council presidency, health ministers agreed to “examine the feasibility” of aligning national vaccination schedules by 2020, in a Council recommendation that was watered down from the Commission’s proposal.
The bar remains low, with Pintea pledging to assist “an exchange of best practices and expertise” to move that forward.
Romania is among the countries in Europe that’s seen the highest number of measles cases over the past two years, driven by growing vaccine hesitancy.Pintea piloted a door-to-door measles vaccination campaign with global health agencies that has seen success. The presidency plans to hold a workshop to share such ideas on May 9-10.
Romania’s aim: Identify success stories
6. Cross-border health
Pintea pledged to “identify better ways of implementing” the EU’s cross-border health care directive, which allows people to use medical services in other countries.
There has been limited uptake and the biggest barrier is people’s lack of awareness about their options, according to a Commission report in June that said national information points aren’t effective. Health ministers will discuss “ways to better implement” the directive at April’s informal Health Council, Anghel said.
Another focus will be to boost cooperation between countries in treating kids and teenagers with rare diseases, as the EU reviews its rules for both orphan and pediatric drugs.
“Orphan drugs are often distributed unevenly or in quantities that don’t cover patients’ needs,” Anghel said. The cross-border directive established European Reference Networks to connect rare disease patients with specialists across the EU, but there's been difficulty integrating the initiative into national health systems.
Romania’s aim: Exchange of views
7. Digital health
Digitizing patient records and making data widely available is contingent upon countries upgrading their systems. That leaves the EU in a mostly cheerleading role to espouse the benefits of investment in the right technology.
Pintea said she will focus on the security of medical data, as well as “better development of electronic registers of patients and medicines.” The presidency will host a high-level e-health conference in Bucharest in June.
The Commission plans in early 2019 to ask countries to commit to electronic health records, proposing a recommendation that would set technical standards. But Romania could be short of time to see that through the Council.
Anghel said Romania’s goals in this area are “still under discussion.”