Insights & news

European Commission Tables Health Technology Assessment Proposal

  • 01/02/2018
  • Articles

On 31 January 2018, the European Commission presented its highly anticipated but also controversial proposed Regulation on Health Technology Assessment (“HTA”) (the “Proposal” – see attached). HTA is a technique to evaluate the medical, social, economic, organisational and ethical issues of a health technology, including medicines, medical devices and medical interventions. The main purpose of conducting an assessment is to inform policy decision-making.
Cooperation on HTA among EU Member States has been in existence since the 1980s and over the years substantial EU funding has been made available under successive Joint Action programs. The last such program will run until 2020. The European Commission now wants to increase the existing cooperation between Member States to enhance efficiencies, reduce public sector costs and augment regulatory and administrative predictability for the life sciences sector. At the same time, the scope of the Proposal is limited to the clinical aspects of HTA and encompasses problem definition and the relative safety and clinical efficacy of a health technology when compared with those of existing technologies.
In practical terms, the Proposal envisages the following four avenues of cooperation:

  • Joint clinical assessments;
  • Joint scientific consultations in response to requests for advice from the life sciences sector;
  • Identification of emerging technologies (known as “horizon scanning”); and
  • Voluntary cooperation in areas outside the scope of mandatory cooperation.

The Proposal covers two types of health technologies: (i) medicines that are subject to the EU’s central marketing authorisation run by the European Medicines Agency; and (ii) specific medical devices that have received an expert opinion at the EU level pursuant to the new EU Medical Devices Regulations.
Initial reactions to the Proposal have been mixed, with Germany voicing the most explicit criticisms. The Proposal will expose the tensions that exist in Europe between advocates of enhanced cooperation between Member States in an area that is in the immediate proximity of Member State turf, namely pricing and reimbursement, and proponents of national sovereignty in the healthcare field that is funded mainly from national coffers.

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 23/05/2019
    • News

    Koen T’Syen speaks at EU Pharmaceutical Law Forum in Brussels

    On 22 May 2019, Van Bael & Bellis counsel Koen T’Syen participated in a panel at the three-day EU Pharmaceutical Law Forum in Brussels, Europe’s leading pharmaceutical law conference. The topic under discussion was market access and the convergence of regulation, pricing and reimbursement. Other members of the panel were Arianna Greco (Vice President, Head of International Legal, Alnylam Pharmaceuticals, Switzerland) and Hanneke Later-Nijland (Counsel, Axon Lawyers, the Netherlands). Details of the conference can be found here.

    Read more
    • 20/05/2019
    • Articles

    Medicine Shortages - Growing Pressure on European Commission To Take Action in Next Legislative Cycle

    On 17 May 2019, a broad group of organisations representing patients, consumers, healthcare professionals and public health advocates called on the European Commission to investigate medicine shortages and take appropriate action that complements the work undertaken by a joint task force of the heads of national medicine agencies and the European Medicines Agency (“EMA”) (see annex 1 - letter addressed to European Commissioner responsible for Health and Food safety Vytenis Andriukaitis and the Director General for Health and Food Safety, Anne Bucher). The initiative comes ahead of the European elections at the end of May 2019 which will create a new European Parliament but will also trigger the designation of a freshly composed European Commission. The letter advocates action “during the next legislative period”. The letter reflects the position of heavyweight organisations such as the European Association of Hospital Pharmacists which, in November 2018, published the results of a pan-European survey (1,666 responses from 38 countries) on medicine shortages in the hospital sector and listed the major challenges to be tackled (annex 2). It is the latest voice in a growing chorus of calls from various sectors in favour of action at the European level. For example, in early April 2019, the European Society for Medical Oncology, published its own set of “recommendations for the 2019-2024 legislative cycle”, including the adoption of legislation for early notification requirements for medicine shortages and the creation of catalogues of shortages (annex 3). Earlier, in February 2019, France’s pharmaceutical trade association Leem came out in favour of increased cooperation between national and European regulators to tackle what it described as a sharp increase in the number of medicines at risk of shortages (annex 4). According to Leem, in 2008 companies reported to the French medicines regulator ANSM 44 medicines of major therapeutic interest at risk of or experiencing shortages. That number grew to 538 in 2017. Leem attributes the shortages to an expanding global demand coupled with insufficient production capacity, as well as changes in production chains, controls and regulatory obligations. It supports an EU-wide effort to monitor shortages and also recommends a boost in the EU-based production of active pharmaceutical ingredients. Additionally, Leem backs improvements to hospital public procurement mechanisms and to the exchange of information between the various stakeholders in the medicine supply chain. Leem’s proposals follow in large part the findings of a report which the French Senate released in October 2018. The pressure on the incoming European Commission to put medicine shortages high on its list of priorities is considerable and is thrown into sharp relief by Member State initiatives such as that of Belgium which try and address medicine shortages at the local level (see, Van Bael & Bellis Life Sciences Newsflashes of 8 and 17 May 2019).

    Read more
    • 17/05/2019
    • Articles

    Belgium - Medicine Shortages - New Developments

    On 14 May 2019 the head of the Federal Agency for Medicines and Health Products (“FAMHP”), Xavier De Cuyper, sent a letter to all stakeholders in the pharmaceutical supply chain explaining his organisation’s view on the effects of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (the “Letter” - see attached). The Letter has since been published on the FAMHP website.   The Law of 7 April 2019 introduces a range of measures to reduce medicine shortages in Belgium (see, Van Bael & Bellis Life Sciences Newsflash of 8 May 2019). The Letter focuses on the practical consequences of the specific rule that limits the categories of customers to which a wholesaler (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) is allowed to supply. These groups of potential customers are (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules. As a result, WS with a public service WS status will no longer be able to sell medicines abroad.   The Letter highlights what FAMHP considers to be the following practical effects: Suppliers will no longer be able to refuse supplies to WS with a public-service WS status who will have to meet their public-service obligations in Belgium at all times and for that purpose require reliable and uninterrupted sources of medicines. The Letter stresses that FAMHP will monitor and enforce the supply obligation.  WS with a public-service WS status can no longer sell abroad. To the extent their owners want to continue pursuing export activities, these will have to act through a distinct legal entity that will require a separate WS licence. FAMHP will also monitor the obligation imposed on WS with a public-service WS status only to supply the limited categories of customers defined by law. The status of community pharmacists and hospital pharmacists does not change. Holders of marketing authorisations are required to report the unavailability of specific medicines. Additionally, WS with a public-service WS status and pharmacies are urged to report medicines that as a practical matter are not available even though they do not feature on the dedicated website of medicines reported as unavailable by the marketing authorisation holders.   The Letter addresses the status of ordinary WS only in passing (for example, by indicating – as noted – that ordinary WS will still be able to engage in export activities). In reality, the role and status of ordinary WS does not change under the Law of 7 April 2019.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *