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Volume 38, Issue 11
Parliament throws wrench in Commission’s plan to regulate HTA.
Anyone wanting a bird’s-eye view of the political operating context for the European pharmaceutical industry need look no further than this autumn’s debates on health technology assessment (HTA)-and particularly the European Parliament’s view of how to regulate it.
The Parliament reached its opinion on this complex legislative proposal in early October. Compared to the European Commission’s original plan for a streamlined European-level HTA, the Parliament wants to put the brakes on. For the Parliament, an EU-level assessment isn’t enough. They want Europe’s numerous national and regional HTA bodies to retain the right to run some of their own checks, even after the joint assessment in the Commission’s proposal.
As far as drug companies are concerned, that won’t work. The European industry backed the Commission’s proposal when it came out in the spring, because it believed an EU-level HTA could speed and simplify a process that was becoming increasingly complicated in Europe’s fragmented market. It would, industry hoped, eliminate the duplication and delay and discord arising from a multiplicity of local HTA bodies.
But if each local HTA body is going to continue running its own “complementary assessments”-as the Parliament calls the opt-out it wants to create-then the industry sees a risk that it will face not just a persistent inconsistency among HTAs in each member state, but an additional-and valueless-HTA at the EU level, too. An extra barrier, rather than a reduction in barriers.
In addition, the Parliament wants to exact a heavy price from drug firms for making use of the envisioned new system-not so much in money, but in terms of conditions and requirements for evidence, and in disclosure of information. The list of what the parliament wants to see as supportive evidence for an application for an HTA runs to several pages. Its belt-and-braces approach would generate delay, impose demands not always necessary, and discourage rather than bring speed and simplicity.
The Parliament’s lengthy requirements start with demanding that companies must present “all available up-to-date documentation containing the information, data, and studies, including both negative and positive results, that is necessary for the joint clinical assessment. That documentation shall include the available data from all tests performed and from all the studies in which the technology was used.”
It also demands that the supportive data that industry provides should be made public, with only the scantest safeguards for commercial confidentiality. It repeatedly warns against conflicts of interest, and puts all the emphasis on transparency and data disclosure: “Transparency and public awareness of the process is essential. All clinical data being evaluated should have, therefore, the highest level of transparency and public awareness in order to gain confidence in the system. In case there is confidential data for commercial reasons, the confidentiality needs to be clearly defined and justified and the confidential data well delimitated and protected.”
In response to these demands, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing smaller firms, as well as the European Federation of Pharmaceutical Industries and Associations (EFPIA), said: “We regret that the European Parliament introduced the requirement that all clinical trial data should be submitted by health technology developers.”
To make matters worse, the opportunities for drug companies to be involved in the assessment process are heavily reduced in the parliament’s take on the system. The parliament has eliminated or diluted several of the Commission’s initial recommendations for constructive interaction. Some industry-friendly Members of the European Parliament (MEPs) attempted to reinstate them during the debates over the proposal, with a new provision that the assessors “shall meet with relevant health technology developers to define the scope of the assessment and the available up-to-date documentation to be submittedÂ,” but this was rejected in the parliament’s final vote.
And as if all that wasn’t enough, the parliament’s opinion is laced with clauses that display skepticism, even hostility, to the drug industry, with criticism implicit and explicit to pricing practices, to the value of its products, and to the principles behind its research.
It repeats the allegation-made by EU health ministers two years ago-that “the main barriers to access are the lack of new treatments and the high price of medicines, which in many cases do not have added therapeutic value.” It points a critical finger at what it sees as current deficiencies in drug evaluation: “Marketing authorizations are not accompanied by a comparative effectiveness study.” It turns its back on any suggestion that innovation should benefit those who generate it, championing “innovation which offers the best outcomes for patients and society as a whole,” and it focuses the legislation on a “high level of health protection,” rather than its original aim of speeding market access and boosting competitiveness.
The distrust of the private sector among MEPs is evident in its view that HTA should be promoted as a mechanism for “steering research strategically” and for “more efficient research.” And for the parliament, of equal importance to bringing innovations to patients is the deployment of HTA as a “help in decision-making on divestment in cases where a technology becomes obsolete.”
And these were just some of the milder comments expressed by MEPs during the evolution of the parliament’s opinion. Some wanted the assessment to go much further-even intruding into economic and social aspects. Far-left Czech MEP Katerina Konecna said in an early debate on the proposal: “I dislike the lack of an obligatory evaluation of the cost of a medicine. It is a mistake to exclude the social, ethical, and economic aspects of evaluation.” Romanian socialist Maria Grapini wanted a direct link to achieving “the best cost-effectiveness ratio.”
If things are difficult in the parliament, it’s going to be seen as a walk in the park compared to the battles that are about to be waged in the other branch of the EU legislative machinery, the Council of Ministers. At least the parliament has paid lip service to the idea of removing duplication. But in the Council, some of the biggest member states are digging their heels in deeply at the Commission’s proposal.
At the top of this list of dislikes is what critical member states see as an unjustified and unwanted intrusion into their own autonomy for making decisions on anything to do with the pricing and reimbursement of drugs. And that is closely followed by their flat refusal to entertain any obligation to use an EU-level assessment instead of their own: for them, they know best how to judge what their patients need, and they don’t want other member states’ views to get in the way of that-much less a view from a consortium of member states.
Under the Commission proposal, “national decision-making capacity of member states is compromised,” France and Germany stated in a direct challenge. “The text must be changed.” The Bulgarian presidency, after testing the waters in the Council in the early summer, concluded that “member states have not identified mandatory uptake of joint HTA as a necessary solution.” Some countries questioned whether the duplication that the proposal aims to reduce is in itself a problem, and suggested that diversity among national assessments was an argument against rather in favor of harmonization. And others argued that the Commission aim of limiting joint assessment to the clinical aspects alone is “practically impossible,” claiming that it is unrealistic to separate the clinical part of the assessment from the economic part.
Small wonder, then, that EFPIA Director General Nathalie Moll claims to be bewildered in her reaction to the situation. “The proposed HTA regulation is not, or at least should not be complicated,” she says. The joint HTA reports will be written by member states for member states, so “how can one object to the use of reports that one has been part of developing?” she asks. “It is difficult to see why member states would need to complement joint reports with additional national data.”
That is where the European drug industry will have to win its campaign in the coming months if it really wants a simplified and streamlined HTA system.
Reflector is Pharmaceutical Executive’s correspondent in Brussels