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Reflector is Pharm Exec's Brussels correspondent.
Figuring out the workings of the EU in topics related to health can be akin to deciphering Egyptian hieroglyphs, making it challenging for companies to plan ahead, writes Reflector.
Figuring out the workings of the European Union in topics related to health is sometimes akin to deciphering Egyptian hieroglyphs. Which can make it challenging for companies to plan ahead, particularly in areas where legislation is likely to change, and where companies are going to have to adapt their operations accordingly. How to second-guess the future accurately in the face of the opaque, the oblique, the esoteric and the unknown (and I'm not even talking about Brexit this time!)?
As a case in point, try this for size. "It is important that the reluctance to shift competencies in a largely non-harmonized area is not confused with a reluctance to cooperate further on health, and vice versa: the desire to keep health on the EU agenda is not interpreted as a willingness to transfer responsibilities to the EU."
If this were just a footnote in an academic treatise in some obscure journal, it would hardly be worth parsing. But it is a central element in a European Council paper that was sent to national health ministers ahead of the June meeting of the EU's Health Council, which gives it some status. And it was scheduled to be an important meeting too, because one of the principal agenda items was a discussion on the future of EU health policy.
But what does it mean? Simply put, it is saying something like "national governments won't accept any push by the EU to railroad them into taking orders from the EU on health matters; countries may be ready to work together on a voluntary basis, but don't take that as a sign that they want the EU taking over from them."
It's a longstanding area of tension familiar to anyone who has followed European health debates: the EU treaties give the EU only very limited powers in health policy, and most health decisions – like how to treat patients, organize health services, or fix prices – remain under national control. Member states have repeatedly feuded with the European Commission over apparent or suspected intrusions into those areas of national sovereignty.
And why has the issue popped up again now? If you take the European Council at its word, it is time to reconsider EU health policy in what is "a period of intense debate on the future of the policies of the European Union". This broader debate has been triggered by a strategic review started last year by the European Commission, and by the upcoming negotiations on how much the EU is going to spend over the next seven years, and what it is going to spend on.
The Council adds that it "should also be seen against the rapid development in fields such as eHealth, pharmaceuticals and medical devices." In other words, the world is moving under the feet of health ministers, and this should motivate them to take a fresh look at what they really want to do at European level.
But there is another strand to this debate that brings an important nuance to its interpretation. The debate has been convened by Bulgaria, which is just coming to the end of its six months in the rotating chair of EU Council meetings. And during its six months term of office, Bulgaria has been pushing on some of its most sensitive points on health.
Notably, as one of the poorest countries in the EU, it finds itself in great difficulties to afford some of the higher-priced new medicines that are becoming available in the EU. In fact it is doubly disadvantaged by its relative poverty, because the medicines that are available in Bulgaria tend to have lower prices than elsewhere in the EU – so they frequently disappear from the national market before they reach patients. They are routinely shipped to higher-priced countries by parallel traders taking advantage of the freedoms of the EU's single market, leaving Bulgaria facing drug shortages.
Justifiably or not, Bulgaria harbors deep suspicions that the drug industry, which it perceives as a largely uncontrolled force in European healthcare, is largely to blame for its domestic problems. It sees its own autonomy challenged by the growth in influence of a Big Pharma complex unsympathetic to the interests of patients. This is accompanied by what Bulgaria fears is a concentration and centralization of power at European level, driven by technocrats and bureaucrats in a time of profound technological and economic shifts.
Over the last six months Bulgaria has consistently opposed any initiatives that it sees as marginalizing the member states – and particularly the smaller and poorer ones. "Topics inherent to health such as eHealth, pharmaceuticals, medical devices, standards for medical services or even health systems, are already increasingly being dealt with at Union level by experts on digitalization, research, trade, social or other policies," it said in its invitation to the Council debate. It summarized its aim for the debate as "to provide an opportunity for health ministers to shape the political agenda by setting a strategic vision from member states' perspective."
The rest of its invitation urged a health policy giving priority to social considerations rather than trade or innovation. The right framework would stimulate industries "to deliver for patients", and health policy would act "as a broker, whenever public and private interests diverge," said the Bulgarian invitation.
Where does all this leave health policy? Troubled, but not yet fixed. Troubled because of many tensions that the Bulgarian invitation evokes. Not yet fixed because Bulgaria is not in a position to dictate policy to other member states, and the debate will roll on for months and even years yet.
In practical terms, however, the more immediate future of health policy has become still more clouded, with direct implications for some practical questions. Top of the list is how drug firms should start making adjustments to their preparations for health technology assessment, because this is likely to change. But just how it will change is still in the lap of the gods that create EU legislation - the Council and the European Parliament.
A European Commission proposal early this year envisaged requiring member states to work more closely together on at least the clinical part of these assessments, so as to reduce some of the duplication or divergence in the way that authorities decide on the merits of a new medicine. But member states – and MEPs – are baulking at the idea of obliging HTA authorities to cooperate, and requiring national governments to make use of the jointly-agreed assessments.
The sensitivities provoked by the proposal reflect precisely those concerns at the root of Bulgaria's anxieties about losing control of its own affairs. Another Council document notes that many countries have expressed "significant concerns regarding key aspects of the proposal" – particularly over the mandatory uptake of joint HTA. The report states that "the most problematic provisions were those envisaging assessments with a binding impact on member states and a prohibition of national assessments".
Meanwhile national parliamentarians in France, Germany, the Czech Republic and Poland have accused the proposal of advising that the EU should overstep its role. Numerous MEPs – and notably the Spanish socialist Soledad Cabezón, who is drafting the report for the Parliament's influential health committee – want to ensure that national powers are not eroded by the proposal.
The initial aim of the Commission proposal – largely supported by drug firms – was to streamline the HTA process, and make market access more predictable, faster and more efficient. The Commission's careful phrasing of the proposal, which limits the joint work strictly to the clinical elements of an HTA dossier, was designed to leave intact member states' rights to make their own subsequent national decision on whether to reimburse a new product, and at what level, taking account of their own national circumstances.
But the feverish atmosphere in which this proposal is now being discussed – neatly demonstrated by the Bulgarian invitation to debate health policy – is threatening to derail it completely. Suggestions of joint clinical assessment are automatically being read by hostile national authorities and parliamentarians as an industry-backed ambush of HTA as a whole, and consequently an assault on national rights and privileges by a power-hungry centralizing elite.
In other words, confusion reigns in the heart of EU discussions of health policy. And for pharmaceutical executives, the price is likely to be high. It is likely to include a disappointing continuation of a manifestly wasteful HTA system that requires drug developers launching a new product to deal with more than 50 separate institutions in Europe – often each producing a different evaluation. The outlook is just as difficult to decode as the most convoluted depiction of quails, reed baskets and horned vipers on Tutankhamen's tomb – and a lot more urgent.