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
    • 12/02/2019
    • Articles

    European Parliament Raises Issue of Alleged Excessive Pricing of Orphan Medicine

    In a response to two parliamentary questions of 6 February 2019, the member of the European Commission (the “Commission”) responsible for health and food safety Vytenis Andriukaitis announced that the case of chenodeoxycholic acid Leadiant (“CDCA”) will be taken on board in the European Commission’s ongoing assessment of the rules governing orphan medicines. According to the Commissioner, the case is also likely to inform competition investigations of possible excess pricing cases (see attached parliamentary questions and answer). CDCA is indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder. These patients are unable to produce enough of the primary bile acid chenodeoxycholic acid. When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage. Because the number of patients with this condition is very limited, the disease is considered ‘rare’, and CDCA was designated as an orphan medicine in December 2014. CDCA is also a hybrid medicine in that it is similar to a reference medicine, Xenbilox, with the same active substance. However, Xenbilox differs from CDCA in that it is only authorised to dissolve cholesterol gallstones, an indication in use since the 1970s under the name Chenofalk. Leadiant Biosciences (“LB”), the marketing authorisation holder of CDCA, is accused of having monopolised chenodeoxycholic acid and then acquired the exclusive marketing rights associated with the orphan medicine designation of CDCA. The price for the medicine would have gone up considerably. According to one of the Members of Parliament who raised the issue, LB now charges EUR 140 per pill in specific markets, while the medicine cost 30 eurocents per pill when it was still sold as an anti-gallstone medicine. The accusation of excessive pricing is understood to be under review by the Dutch competition authority. The case raises a range of issues and themes that have recently come to the fore in political discussions across the European Union, including the status of orphan medicines; the tackling of excessive prices under the competition rules (the European Commission has not only started a procedure of its own in another file, but says it also supports various efforts of national competition authorities in that area); and possible cooperation among Member States with regard to medicine pricing and reimbursement, a controversial subject which the Commission stresses belongs to the exclusive competencies of the individual Member States.

    Read more
    • 30/01/2019
    • Articles

    Belgium - Liberalisation of distribution channel for medical devices

    A Royal Decree of 18 December 2018 regarding the liberalisation of the distribution channel for medical devices (the “Royal Decree”) was published in the Belgian Official Journal on 28 January 2019. The Royal Decree abolishes a number of provisions for the purpose of allowing supermarkets and other stores to also sell, as from 7 February 2019, certain medical devices that until now could only be sold through pharmacies (these devices are listed in the Royal Decree of 18 March 1999 on medical devices, annex XIII, items 1.1 through 1.5). Belgium thus seeks conformity with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices pursuant to which “Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation” (Article 24). The Royal Decree applies to all medical devices that are available without prescription. In practice, it is expected to impact mainly the distribution of sterile medical devices, such as tubes and band aids, which until now could be sold only through pharmacies. By contrast, the sale of medical devices available on prescription remains limited to pharmacies. The supermarkets and other stores that will sell medical devices under the Royal Decree will have to meet the same quality, security and traceability criteria as the pharmacies and will need to register in advance with the Federal Agency for Medicines and Health Products. According to the Minister of Public Health, Maggie De Block, foreign examples show a marked price decrease of medical devices when these are also made available outside the pharmacy channel. The Minister hopes that the Royal Decree will have the same effect on pricing. Here goes a link to the Dutch and French versions of the Royal Decree of 18 December 2018 : Royal Decree of 18 December 2018

    Read more
    • 29/01/2019
    • Articles

    Pharmaceuticals - European Commission Publishes Competition Law Enforcement Report and Declares Such Enforcement Continuing Priority

    The European Commission published today an overview of the enforcement activities of the European competition authorities, i.e., the Commission itself and the national competition authorities of the 28 Member States (the “Competition Pharmaceutical Enforcement Report” or “CPER”). The CPER covers the period 2009-2017 and follows the Commission’s wide-ranging inquiry into competition in the pharmaceutical sector which in July 2009 gave rise to its sector-inquiry final report ( According to the CPER, the competition enforcement activities have focused on two main objectives, namely access to cheaper medicines and access to innovative medicines. Access to cheaper medicines The Commission maintains that, in addition to their work in the merger control arena, the European competition authorities have made significant efforts to investigate and penalise practices that result in higher medicine prices. It offers as an example the patent settlement agreements reviewed at the European level and in the UK in order to curb market-entry delaying effects that may result from some agreements of that nature. Only last month, the Commission suffered something of a setback in that respect following the partial annulment by the General Court of decisions which it had adopted in the Servier cases (see, Van Bael & Bellis Life Sciences Newsflash of 24 December 2018). Other enforcement cases intended to bring down medicine prices include the excessive pricing cases pursued or pending in Denmark, Italy, the United Kingdom and before the European Commission. Interestingly, the CPER also cites the procedures conducted by the French competition authority against disparaging statements made by incumbents regarding newly launched generic rival products. Access to innovative medicines and increase of choice The Commission’s focus under this heading seems to be on preserving competition in pipeline products when applying the merger control rules. When it comes to classical competition enforcement, the Commission again refers to its actions against attempts to delay generic market entry. The Commission considers such action necessary to guarantee the end of the innovator’s market exclusivity and spur further innovation on the innovator’s part. The CPER concludes by making it clear that enforcement of the competition rules in the pharmaceutical sector “remains a matter of high priority”. The Commission says it will pay particular attention to new industry practices and to new market trends such as the emergence of biosimilars. At the same time, the Commission acknowledges that “there are limits to what competition law can do”. It specifies that sustainable access to affordable and innovative medicines will depend on the efforts of all stakeholders, including the pharmaceutical sector, governments and regulators, health care providers and patients. For good reason, the CPER not only discusses the application of the competition rules but also repeatedly refers to regulatory action. The Commission issued today the following documentation:

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *