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EUCOPE Calls for Additional Considerations in Joint EU HTA Discussions

Date: March 19, 2021 | Country: BELGIUMFRANCEGERMANYITALYPORTUGALSPAIN | Region: EUROPE | Type: HTA | Keywords: #collaboration #eu #eunethta #hta #joint #policy #portugal #presidency

PRICENTRIC BRIEF:

  • The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has released a statement “welcoming” recent collaborative effort made by the Council of the EU to reach a compromise on the EU’s previous “Proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU,” but noted simultaneously that the direction of the “current compromise” is substantially “changing central parts of the proposed Regulation”
  • Portugal, which is currently in the EU Presidency seat, aims to receive a mandate to start trilogue negotiations with the Commission and Parliament in the next weeks, but noted in a meeting on March 16 that ongoing negotiation is currently difficult
  • EUnetHTA is holding its 2021 forum virtually, on 15 April, but EUCOPE has cited concern ahead of discussions about a number of provisions that might bring additional regulatory and administrative burden and an added level of uncertainty for small to mid-size companies

 

THE DETAILS

BRUSSELS, Belgium – The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has released a statement “welcoming” recent collaborative effort made by the Council of the EU to reach a compromise on the EU’s previous “Proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU,” but noted simultaneously that the direction of the “current compromise” is substantially “changing central parts of the proposed Regulation.”

Portugal, which is currently in the EU Presidency seat, aims to receive a mandate to start trilogue negotiations with the Commission and Parliament in the next weeks but noted in a meeting on March 16 that ongoing negotiation is currently difficult.

In particular, EUCOPE cited concern about a number of provisions that might bring additional regulatory and administrative burden and an added level of uncertainty for small to mid-size companies.

EUnetHTA is holding its 2021 forum virtually, on 15 April.

Ahead of the interinstitutional negotiations, EUCOPE has underlined a number of considerations to be included in the discussions to help mitigate any negative changes to the collaboration:

  • Sufficient management of evidentiary uncertainties for OMPs and ATMPs to prevent delays in patients’ access
  • Mandatory uptake of joint clinical assessment at national level to reduce regulatory burden
  • Early scientific advice for all manufacturers for increased predictability

OMPs and ATMPs

According to EUCOPE, the original Regulation Proposal put forward by the European Commission in 2018 needs adjustments to provide for a sufficient level of flexibility in specific cases, such as for Orphan Medicinal Products (OMPs) and Advanced Therapy Medicinal Products (ATMPs).

The group has rallied for these changes in the past, but has now reiterated the “need for a flexible regulatory framework that can manage evidential uncertainty in specific cases where appropriate.”

This is because EUCOPE believes the proposed “one-size-fits all” methodology, which doesn’t account for specificities of therapies developed for small patient populations, would inadvertently cause “considerable delays in assessments and ultimately hinder patients’ access to those medicines across the EU.”

Joint Assessment at National Level

The current proposal follows the idea of “non-duplication” principle, according to EUCOPE, meaning that the evidence submitted in joint clinical assessment at the EU level shall not be requested again at Member States level.

The organization responded, “our reading is that this does not explicitly preclude Member States to ask for additional data,” highlighting a concern that “if the Council proposal does not allow for any binding effect on Member States, this will inevitably result in duplication of work, posing continued regulatory burdens on companies and, in particular for small to mid-size companies, that lack the resources to face both the uncertainty and the additional workload that such a process might bring.”

Early Scientific Advice

In its current state, the 2018 proposal provides selection criteria for access to joint scientific consultation based on application by the manufacturer, meaning that not every manufacturer that enters into the evaluation process and seeks scientific advice will therefore receive it.

EUCOPE believes that scientific advice is a crucial procedural step, and is therefore essential to all future HTA cooperation at EU level. In addition to this, limiting early consultations within the framework of the EU procedure will reduce transparency and predictability, according to the group.

Joint HTA in the EU

EUNetHTA and the EMA laid out plans to have close interaction between relevant regulators, HTA bodies and other bodies to reduce developmental resources, by re-shaping and focusing on medicine development programs to generate data relevant for regulators, HTA bodies and other stakeholders. However, the funding for EUNetHTA ran out in 2020, forcing the parallel EMA/EUNetHTA consultation to be suspended temporarily in mid-2020.

Commitment has now been made to continue these consultations until May 2021 in the form of additional funding, in order to ensure the EUnetHTA initiative continues to allow member states to free up and re-allocate resources to measure the performance of interventions in the wider healthcare system.

In general, cross-border market access collaborations like BeNeLuxa, Valletta Declaration Group and the International Horizon Scanning Initiative, have become more common in the past five to 10 years.

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