Early on Tuesday morning the European Parliament and Council negotiators reached a provisional agreement on a joint health technology assessment (JHTA).
The European Commission has been calling for a mandatory joint clinical assessment for a while now, in the hopes that it’ll reduce the amount of work duplication for both, local HTAs and pharmaceutical companies and thus support faster patient access. However, since its proposal was submitted in December 2018 the proposal saw opposition from several member states, including France, Germany and Spain whose key concerns included:
- the timetable for the implementation
- the potential quality of the assessments
- and the degree to which member stated were obliged to use the joint clinical assessments (JCAs)
and no decision had been officially made on the matter, until now.
The provisional agreement
Although the details of the regulation are still to be agreed, much of it is focused on establishing transparency. Here is what we can expect from the agreement at this time:
A Member State Coordination Group
This group will be established by the regulation and will require each EU country to delegate a representative to it and its subgroups. The agreement highlights the need for complete transparency, the chosen representatives are not permitted to have any interest in the health technology developers’ industry as this could impact their impartiality.
Transparency and Inclusion of Stakeholders
It is clear that transparency and inclusiveness is at the heart of the regulation. The Coordination Group is anticipated to engage in wider stakeholder dialogue by seeking relevant consultation where appropriate. During negotiations it has been agreed that a stakeholder network should be created to facilitate this, it is anticipated to include organisations which represent patients, clinical experts, healthcare professionals, consumers and HTA developers.
Clarity and Openness in Work
Apart from securing greater transparency in relation to joint clinical reports and work , the Parliament has also agreed on a clear criteria to diverge scientific opinions. This is hoped to ensure that the legitimacy of reports is not questioned.
Additionally, member states will be expected to:
- annex the joint clinical assessment in their national assessments
- report on the use of joint clinical assessments in national HTAs.
It is also expected to ensure that a clear criteria is set for the selection of joint scientific consultation, shortening the time taken for full implementation and establishing a level playing field for all involved.
Discussion
Whilst the EESC has released a positive opinion of the regulation prior to the release of the provisional agreement, the The European Federation of Pharmaceutical Industries and Associations (EFPIA) has now expressed it’s concern over the leniency of it. In a statement, titled “EU HTA; compromise but at what cost?” the association writes:
“We regret that a stronger framework for the use of Joint Clinical Assessments could not be agreed upon. We maintain that the shape of the compromise risks introducing an unpredictable system whereby member states decide on a case-by-case basis if and how they commit themselves to use jointly conducted clinical assessments.
This will create unnecessary administrative and regulatory barriers to patients’ access to new medicines introduced in Europe.”
Next steps
Next, the Presidency of the EU Council, will submit the outcome of the negotiations to the Council’s Permanent Representatives Committee for endorsement. The council will adopt the regulation first, shortly followed by the European Parliament.
The new rules will not come into place until three years after the regulation is enforced. This, coupled with the planned phased introduction approach detailed below, means that the regulation may not be fully implemented for another 11 years.
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