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    • 11/01/2022
    • Articles

    Clinical Trials Regulation - Cooperation of Member States in Safety Assessment of Clinical Trials

    The European Commission published yesterday a Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 “laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials” (the Regulation; see, attached copy).

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    • 10/01/2022
    • Articles

    EFPIA Publishes Regulatory Wish-List Ahead of European Commission Proposals for Pharmaceutical Reform Due in 2022

    As you know, as part of its wide-ranging EU Pharmaceutical Strategy, the European Commission (the Commission) plans to submit proposals for changes to the EU regulatory framework governing medicines later this year. EFPIA, the European Federation of Pharmaceutical Industries and Associations which represents the innovative pharmaceutical sector, anticipated this significant milestone in the rule-making process by publishing a list of recommendations for regulatory modifications (see, attachment).

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    • 03/01/2022
    • News

    Catherine Longeval appointed Co-Chair of the International Bar Association (IBA)’s Healthcare & Life Sciences Law Committee

    Van Bael & Bellis is pleased to announce that Catherine L. has been appointed Co-Chair of the International Bar Association (IBA) effective January 1st, 2022. This appointment recognizes the high standing of our firm’s thriving life sciences practice in the international life sciences community. Catherine’s Co-Chair during the first year of her two year mandate is Jonás Bergstein of Bergstein Abogados in Uruguay. Together with a dedicated team of fellow Officers, they are committed to further enhancing the visibility and the work of that Committee, which has a dynamic and diverse membership spanning all continents. The Committee focuses on all aspects of healthcare law, pharmaceutical, biotech and medical devices regulatory law, intellectual property, bioethics and scientific developments across the globe. It provides a forum for discussion among health and life science lawyers and aims to provide regular updates of important changes in this field through newsletters, webinars/seminars and conferences. For more information on the work of the IBA’s Healthcare & Life Sciences Law Committee, please click here.

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    • 23/12/2021
    • Articles

    European Commission Adopts South Korea Adequacy Decision

    On 17 December 2021, the European Commission announced its decision on the adequate protection of personal data by the Republic of Korea (South Korea). After the conclusion of adequacy talks in March 2021, the adoption of the decision marks the final step in the adequacy process. With the adequacy decision, personal data can be transferred freely from the EU to South Korea. Please click on the link below to read our note on the subject.

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    • 23/12/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 11

    The November 2021 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law.

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    • 22/12/2021
    • Articles

    Publication of Regulation on Health Technology Assessment

    The Official Journal of the European Union publishes today the Regulation on Health Technology Assessment (HTA) (Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU; see, attached copy). The publication follows the Regulation’s approval in second reading by the European Parliament on 13 December 2021 and its endorsement by the Council of the European Union on 9 November 2021 (see, Van Bael & Bellis Life Sciences News & Insights of 15 December 2021 and 12 November 2021). While the Regulation on HTA will enter into force on 11 January 2022, i.e., “the twentieth day following that of its publication in the Official Journal of the European Union” (see, Article 36(1) of the Regulation), it will only apply from 12 January 2025 (see, Article 36(2) of the Regulation). As noted earlier, the long interim period will be used to set up the organisational framework contemplated by the Regulation on HTA and to adopt a series of implementing measures. The first meeting of the yet to be established Coordination Group of Member State representatives is scheduled to convene in June 2022. In practical terms, no joint work among Member States pursuant to the Regulation will occur before the first quarter of 2025.

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    • 20/12/2021
    • Articles

    Belgium - Royal Decree Creates Increased Transparency of Medicines Supply Chain

    Following the extended parliamentary trajectory that eventually resulted in new rules governing medicine shortages (see, Van Bael & Bellis Life Sciences News and Insights of 20 December 2019), it took successive federal governments almost two years to come up with the first of what is intended to be a series of implementing measures. Today, the Royal Decree of 29 November 2021 “implementing Article 6, paragraph 1sexies of the Law of 25 March 1964 governing medicines with regard to the transparency of the stock of medicines dedicated for public service obligations” (the RD) is the first such measure to enter into force (see, attachment). The RD establishes a stock monitoring system for wholesaler-distributors (WDs) as part of the public service obligations of that group of stakeholders in the medicine supply chain. Its goal is to give the Federal Agency for Medicines and Health Products (FAMHP) a picture of the medicine stocks held by WD. This should allow FAMHP to have a better view of patient needs, to step in to avert or reduce the unavailability of any given medicine at any particular time, and to develop a policy regarding unavailable medicines and guarantee a steady stream of medicine supplies to meet patient needs. To this end, WDs will be under a duty to provide the following data to FAMHP about sales, purchases and stock positions: • Historical data for 2019, 2020, and January-November 2021; • Monthly overviews (the first data set will cover December 2021). The RD also details a procedure for notifications of unavailable medicines which is based in part on the current usage of the Pharmastatus website. The RD specifically addresses the reporting of unavailable medicines by WDs and pharmacists. Any such notification will have to be assessed by the marketing authorisation holder (MAH) and, based on such assessment, may give rise to a notification of unavailability by the MAH. This complements the existing and autonomous obligation of MAHs to notify unavailable medicines. The RD now specifies in greater detail the information which MAHs are under a duty to supply.

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    • 15/12/2021
    • Articles

    Regulation on Health Technology Assessment Finally Adopted

    On 13 December 2021, the European Commission welcomed the adoption of the Regulation on Health Technology Assessment (HTA) following its approval by the European Parliament in second reading (see, attached European Commission press releases). The Regulation on HTA had cleared its last major legislative hurdle on 9 November 2021 when it was endorsed by the Council of the European Union (see, Van Bael & Bellis, Life Sciences News & Insights of 12 November 2021). HTA is defined in the Regulation as “a multidisciplinary process that summarises information about the medical, patient and social aspects and the economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner”. The Regulation creates collaborative structures and procedures that allow Member States to carry out joint clinical assessments, effect joint clinical consultations and identify jointly emerging health technologies. Additionally, the Regulation offers scope for voluntary cooperation in adjacent areas. At the same time, the Regulation respects a delicate balance with Member State competencies in core areas such as pricing and reimbursement, but also decision-making on the use of health technologies and the management and delivery of health services and medical care. While the Regulation on HTA is now scheduled to enter into force in January 2022, it will not apply until January 2025. In practical terms, this means that no joint work among Member States pursuant to the Regulation will occur before the first quarter of 2025. The long interim period will be used to set up the organisational framework contemplated by the Regulation on HTA and to adopt a series of implementing measures. The first meeting of the yet to be established Coordination Group of Member State representatives is scheduled to convene in June 2022.

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    • 15/12/2021
    • Articles

    Belgium - Parliament Reviews Medicines Related Bills Including Government Bill Containing Various Urgent Provisions on Health

    The Federal Chamber of Representatives is currently discussing a 1,850-pages long government bill containing various urgent provisions on health (Wetsontwerp houdende diverse dringende bepalingen Inzake gezondheid / Projet de loi portant des dispositions diverses urgentes en matière de santé 55K2320 – the Bill). The Bill was submitted to the Chamber of Representatives on 16 November 2021 and is, at the Government’s request, being discussed as a matter of urgency. Here is an overview of the Bill’s noteworthy provisions which, if adopted, will affect the pharmaceutical and medical devices sectors. • Drugs Law – Expanded administrative settlement options (Article 2, Bill). The Bill expands the possibilities for the Federal Agency for Medicines and Health Products (FAMHP) to propose an administrative settlement to infringers of the Law of 24 February 1921 on the trade in poisonous, soporific, narcotic, psychotropic, disinfectant or antiseptic substances and substances that can be used in the illicit manufacture of narcotics and psychotropic substances (the Drugs Law). If the Bill is adopted, the FAMHP will henceforth also be able to propose an administrative settlement for infringements involving narcotics, psychotropic substances and substances that can be used in the illicit manufacture of narcotic drugs and psychotropic substances. Moreover, to ensure that sanctions are imposed in cases which would otherwise be dismissed by the Public Prosecutor, administrative settlements are made possible for “light” infringements of the Drugs Law. Furthermore, the administrative settlement procedure is harmonised with that set forth in Article 17 of the Law on Medicines of 25 March 1964 (the Law on Medicines). • Supply of medicines to educational establishments, scientific institutions and accredited laboratories for scientific research purposes (other than clinical studies and trials) (Article 3, Bill). The Bill inserts a statutory basis in the Law on Medicines pursuant to which the King can adopt rules on the supply of authorised medicines to educational establishments, scientific institutions and accredited laboratories for scientific research purposes (other than clinical studies and trials). Such rules are deemed necessary in view of the closed distribution circuit for medicinal products. It is specified that the medicines concerned cannot be administered or delivered to patients. They can only be used for scientific research purposes (e.g., in vitro investigations). • Administrative simplification within FAMHP (Articles 4-8, Bill). With a view to administrative simplification, the Bill abolishes two of the FAMHP’s advisory bodies, namely the Committee for Medicinal Products for Veterinary Use (Commissie voor geneesmiddelen voor diergeneeskundig gebruik / Commission pour les médicaments à usage vétérinaire) and the Advisory Committee (Commissie van Advies / Commission consultative). The Bill notes that the first Committee, which issues opinions in the context of the national marketing authorisation procedure of veterinary medicinal products, has largely lost its relevance due to the increased use of the centralised, decentralised and mutual recognition procedures. The Committee has not convened once in 2018, 2019 and 2020. The Advisory Committee, in turn, chiefly becomes involved in the context of the award, withdrawal or suspension of manufacturing and wholesale licences. According to the Bill, the Advisory Committee’s involvement entails unnecessary delays considering that all necessary scientific and technical knowledge is available within the FAMHP itself. • Amendments to the Law of 5 July 1994 on blood and blood derivatives of human use (the Blood Law) (Articles 9-12, Bill). The Bill (i) clarifies that the blood donor’s health history investigation must not necessarily be carried out by a physician – other health care professionals can do this as well; (ii) introduces a statutory basis in the Blood Law for a Royal Decree requiring hospitals to report adverse reactions or events with blood and repeals the corresponding requirements in the Royal Decree of 17 February 2005 determining the standards that a hospital blood bank must meet in order to be recognised; and (iii) gives effect, with retroactive effect to 12 November 2021 (see, Article 30 of the Bill), to Constitutional Court judgment No. 122/2019 of 26 September 2019 by allowing, subject to strict conditions, blood (plasma) donations by men who, or whose male partner, had sexual contact with other men. • Vigilance tasks FAMHP (Articles 13-16, Bill). Clarifying the FAMHP’s powers in the field of vigilance, the Bill notes that these powers extend to blood and human body material. Furthermore, the FAMHP is given the power to supervise compliance with the Law of 22 April 2019 on high-quality practice in healthcare insofar as this Law applies to the pharmaceutical profession and to pharmaceutical acts. • Human body material (Articles 17-20, Bill). The Bill corrects in various respects the Law of 19 December 2008 regarding the procurement and use of human body material for human medical applications or for scientific research and brings it in line with Regulation (EU) 2016/679, the General Data Protection Regulation. • Clinical trials – Additional incompatibility College members (Article 29, Bill). In view of the competences of the College in relation to medical devices and in vitro diagnostic medical devices, the Bill adds an additional professional incompatibility to the list of incompatibilities for members of the College contained in Article 9, §2 of the Law of 7 May 2017 on clinical trials involving medicinal products for human use. The Bill clarifies that members of the College cannot hold the position of manager, director, managing director or board member of a manufacturer, importer or distributor of medical devices or in vitro diagnostic medical devices. The College is a body within the federal public service Public Health that plays an important role in reviewing applications for clinical trials such as appointing an ethics committee. • Increase of biosimilar uptake through more efficient use of public procurement procedures (Articles 93 and 94, Bill). The Bill notes that the consumption of biosimilars, which are typically administered, delivered and prescribed in a hospital environment, is much lower in Belgium than in countries such as France, Germany, Italy and the UK, despite the fact that Belgian hospitals have been subject to the public procurement rules since 1 July 2013. According to the Bill, many hospitals still fail to apply the public procurement rules, or fail to apply them correctly, and, for instance, draft the contract documents in favour of the more expensive original biological product. With a view to stimulating the uptake of biosimilars, the Bill inserts a new Article 71bis in the Coordinated Laws of 14 July 1994 on the compulsory insurance for medical care and benefits (the Law of 14 July 1994) which gives the King the power to adopt far-reaching rules “[w]ith a view to rectifying the lack of free competition and/or the non- or sub-optimal application of the Public Procurement Law and the resulting underutilisation of cheaper or potentially cost-saving alternatives”. Amongst other things, the King is given the power to (i) determine the conditions and time limits within which hospitals should award public contracts; (ii) regulate the contract documents, in particular as regards the content of the selection, award and/or technical criteria, the division into lots, and mandatory clauses; (iii) reduce or modulate the maximum duration of public contracts; and (iv) impose the mandatory inclusion of a termination clause in all new contracts pursuant to which the contract will be terminated early in the event of a change in the reimbursement basis. Should hospitals fail to comply with the requirements imposed by the King, their lump-sum compensation for specific classes of medicines (geneesmiddelenforfait / forfait médicaments) may be reduced by up to 10%. According to the Bill, the necessary implementing measures will be adopted “following consultation with the pharmaceutical industry, hospitals and physicians”. • Packaging – Indication of reimbursement status (Article 95, Bill). As the Falsified Medicines Directive requires the packaging of medicines to include a unique identifier, which allows information on the applicable reimbursement terms to be exchanged digitally, the current distinctive logo on the packaging showing that a product is reimbursable (and the applicable reimbursement category) has become redundant and is, therefore, repealed by the Bill. • Continuous availability of advanced therapy medicinal products (ATMPs) (Article 96, Bill). The Bill amends Article 72bis of the Law of 14 July 1994 with a view to authorising ATMP manufacturers to supply the product to Belgian patients in another EEA country. Additionally, referring to the highly specialised nature of a treatment with ATMPS, which are tailored to the individual patient, the Bill explains that it is impossible for ATMP manufacturers to “meet any supply request within three working days”. As this is the legal criterion for assessing whether or not the product is continuously available, the Bill exempts ATMPs from this requirement. • Emergency changes to list of reimbursable pharmaceuticals (Article 96, Bill). The Bill introduces a statutory basis in Article 72bis of the Law of 14 July 1994 for amending the list of reimbursable pharmaceuticals with immediate effect or at short notice. The Bill justifies this change by noting that such amendments may be necessary “in exceptional circumstances such as, for example, a pandemic” to ensure continuity of care for patients, having regard to any medicines shortages, or to ensure access to essential therapies. • Information collection on supplies of non-reimbursable prescription-only medicines (Article 97, Bill). The Bill introduces a statutory basis in Article 165 of the Law of 14 July 1994 for collecting information on supplies to patients of non-reimbursable prescription-only medicines. The Bill notes that the collected information may be used for (i) including the costs of some of these medicines in the maximum invoice for chronic patients; and (ii) developing a medicines policy which, on the one hand, protects socially vulnerable patients against excessive costs and, on the other hand, informs patients and prescribers on their use of non-reimbursable medicines including, in particular, analgesics, psychopharmaceuticals and antibiotics. On 10 December 2021, the Chamber’s Committee for public health and equal opportunities adopted in first reading Articles 1 through 53 and 79 through 168 of the Bill. A second reading has been requested. No vote has yet been cast on Articles 54 through 78 of the Bill, which propose amendments to the Law of 6 August 1990 on the health insurance funds and national federations of health insurance funds. Separately, private members’ bill 55K2352 seeks to accelerate the adoption of the draft provisions contained in bill 55K2320 that broaden the group of possible blood donors, but it is doubtful whether the current parliamentary majority will allow this to happen. Finally, bill 55K2366 reforms the funding of FAMHP which is financed for a majority part by industry contributions. The bill seeks to increase these contributions even further, which inevitably prompts the question whether the service to industry and to society at large adequately reflects these contributions.

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