Small and medium sized Member States vented their frustration with the pharmaceutical industry in a debate at the EU Health Council meeting in Brussels on 8 December. The same meeting adopted Conclusions on digital health and cross-border aspects in alcohol policy.

Ben Duncan
Senior Adviser

The alcohol policy conclusions remind the EU-wide drinks industry of the deadline of March 2018 for them to propose a voluntary labelling scheme on ingredients and calories in their products.

If this self-regulatory scheme is unsatisfactory, then health ministers call on the Commission to launch without delay an impact assessment with a view to submitting to the European Parliament and to the Council by the end of 2019 the appropriate measures aimed at ensuring the provision of relevant information on ingredients and nutritional values for the entire sector of alcoholic beverages.”

Either via industry self-regulation or EU legislation, it looks like we are heading towards new EU wide rules on alcohol labelling. These will certainly cover information manufacturers must put on the label about ingredients (e.g. allergens and additives) and the nutritional value of their product (e.g. how much sugar it contains, how many calories it contains etc.). It is possible that the rules could also cover health warnings: this is a subject for debate (and lobbying) between the industry, health NGOs and policy makers. If industry comes up with a robust system of self-regulation, it is possible the new rules could be in place by the end of 2018. If, as seems more likely, we go down the road of legislation it will likely take 3 or 4 years for new rules to be agreed and implemented.

One other take-away from the discussion on alcohol: alcohol is rising up the public health agenda in many Member States. Indeed, in principle, all Member States are signed up to WHO strategies on alcohol and non-communicable diseases which include a target of reducing “harmful consumption of alcohol” by 10% by 2025. Several countries noted with approval a recent judgement in the UK upholding the validity of a Scottish law setting minimum prices for alcoholic drinks. These will now be implemented in Scotland from May 2018. If minimum pricing has the desired effect on “harmful consumption of alcohol” in Scotland, other EU countries may well introduce similar laws.

The ministerial debate on pharmaceutical policy was part of a process following on from the Council Conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States adopted under the Dutch Presidency in June 2016. There had been numerous technical discussion, high-level meetings, studies and informal political discussions since then. Now must be both the best of times and the worst of times to work in government relations for the pharmaceutical industry in Europe. Industry representatives can have no shortage of meetings to go to or briefings to write! The bad news, though, is that government health budgets have stopped growing – while demand for healthcare has not. Health ministries want to pass on some of their pain to the pharmaceutical industry.

The debate opened with statements from Romania and Greece. Romania has a problem with access to new medicines and availability of existing drugs. It believes that a major reason for this is parallel exports: drugs intended for sale in Romania get bought up by traders who then export them to other Member States, where they can be re-sold for a higher price. Parallel exports are having such a negative impact on availability of medicines that Romania is considering using emergency powers to ban exports. Romania demanded that an EU-wide authorization to put a medicine on the market should come with an obligation to ensure the drug is effectively available in all Member States.

Greece reported on a similar clash between business interests and public health priorities. A “major Swiss pharmaceutical company” had asked Greece to remove one of its cancer drugs from Greece’s schedule of medicines approved for prescription to patients. This followed the imposition of a price rebate on the drug by the Greek authorities. The Greek minister reported that his country had refused to comply with the company’s request. To have done so would have been to give in to blackmail, he said. Greece called for EU cooperation to guarantee “fair and sustainable pricing”, especially for new medicines.

Nearly all Member States contributed to the debate (only Bulgaria and Austria held back). A big majority expressed sympathy and solidarity with Greece and Romania. The countries of Eastern, Central and Southern Europe generally feel poorly served by the pharmaceutical industry. When new drugs receive EU-wide approval these poorer, and often smaller, countries are the last to benefit from them. Often there is a delay of several years between authorization and the drug being distributed in some of these countries. They are also concerned about availability of existing medicines and perceive that shortages are happening far too often. The minister from Slovenia summed up the situation seen from these countries: “We are a small and not particularly attractive market. Over the past few years we have seen access to medicines getting worse – and this is for all medicines, not just new ones”.

These countries have set up buying consortiums to try and negotiate better deals with the pharmaceutical industry. There is a Visegrad consortium, a Baltic consortium, a Benelux consortium and the so-called Valetta group (Cyprus, Greece, Ireland, Italy, Malta, Portugal, Romania and Spain). However, they would like the EU and the Commission to play a more active role. Latvia called for EU guidelines on fair pricing. Others wanted to impose public service obligations on the industry and its distributers.

The argument against EU level action came from the big Member States. France, Germany and the UK were against the EU becoming involved in drug pricing policy and reluctant to change current EU laws. The German minister reminded her counterparts that under the EU Treaties healthcare financing and organisation are matters for Member States, not the EU. Denmark and Sweden also had some words about the importance of encouraging innovation. All five of these countries have researched based pharmaceutical companies. What happens when the UK leaves the EU in 2019, though?

The Netherlands – new home of the European Medicines Agency as of 2019 – is positioning itself as the thought leader on pharmaceutical policy in the EU. The Dutch ministers informed colleagues that “re-balancing” pharmaceutical policy is now part of the Council’s long-term agenda up to 2020. He suggested an annual ministerial-level debate on pharmaceutical policy in the EU’s Health Council up to 2020 and beyond. Denmark meanwhile had another great idea: develop a long term political vision document on patients’ access to innovative medicines. Those industry representatives are going to have plenty of meetings to go to for the next few years.