Insights & news

Belgium - Draft Legislation Governing Human Body Material

  • 02/10/2018
  • Articles

On 27 September 2018, the Bill amending the Law of 19 December 2008 regarding the procurement and use of human body material for human medical applications or for scientific research (the Bill) was submitted to the Chamber of Representatives. A link to the Bill, including the explanatory memorandum, is available here.
 
The main changes to the Law of 19 December 2008 introduced by the Bill are the following:

  1. Allocation of human body material – The Bill requires banks for human body material to provide for allocation criteria in their agreements with intermediary structures and biobanks, in accordance with the principles of transparency and equal treatment. The banks for human body material will have to decide on each request for human body material on the basis of these allocation criteria. A new committee within the Federal Agency for Medicines and Health Products, the “Allocation Committee for Human Body Material”, will offer advice on the application of the new rules. Further rules on the allocation criteria and the new committee will be laid down by Royal Decree.
     
  2. Intermediary structures – The Bill increases the autonomy of the intermediary structures for human body material. In particular, the Bill facilitates the procurement by intermediary structures of (i) human body material used for the purpose of developing and producing allogeneic advanced therapy medicinal products; and (ii) human body material removed in other EEA Member States or third countries. A Royal Decree will establish further requirements for cooperation agreements between intermediary structures and tissue banks from other EEA Member States.
     
  3. Donor recruitment campaigns – The Law of 19 December 2008 prohibits any advertisement campaigns in relation to the removal of, or any other act involving, human body material, with the exception of public campaigns designed to raise awareness for allogeneic donation of human body material that are solely in the interest of the public health. However, many campaigns are not exclusively in the interest of public health, but will also be in the commercial interest of specific actors, e.g., campaigns by fertility centres or campaigns to recruit donors for scientific research. Therefore, the Bill introduces the possibility for banks for human body material to organise campaigns aimed at recruiting healthy donors. The conditions for such campaigns will also be determined by Royal Decree.
     
  4. Scope of application – The Bill amends the scope of application of the Law of 19 December 2008. First, human body material removed and destined for use in a clinical trial will fall outside the Law’s scope. If, conversely, the material is destined for another use, irrespective of the moment at which that happens, it must be transferred to a biobank and will thus be subject to the Law of 19 December 2008. Second, faecal material will be added to the scope of application of the Law of 19 December 2008.

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 07/05/2021
    • Articles

    Pharmaceuticals – Dealing in Uncertain Times – The Article 22 Merger Procedure

    With the Commission’s publication of Guidance on its expanded use of the Article 22 merger review procedure, and its immediate use against the Illumina / Grail transaction, pharmaceutical companies face a new world where any acquisition of a small biotech or company with key technology could now face a merger control investigation and potentially a prohibition. So what can pharmaceutical companies do in these uncertain times… Background In recent years, the European Commission has expressed concerns that large companies in the pharmaceutical and tech sectors are conducting “killer acquisitions” of new entrants or smaller competitors that fall below the revenue thresholds for merger review. In order to address this concern, the Commission expanded the use of Article 22 of the Merger Regulation in a manner that would effectively empower the Commission to review any transaction. Under Article 22, any national competition authority (on its own motion or following encouragement by the Commission or by interested parties) may refer a transaction to the Commission, even if the transaction does not meet EU or national merger thresholds. Further, such a review process can be triggered even after the closing of the transaction. For companies in the pharmaceutical sector, this means that transactions involving a biotech or other company with little revenue could still be subject to a merger clearance process, even after closing, and could potentially result in a prohibition or required changes. Dealing in Uncertain Times Identifying At-Risk Transactions While the Commission has issued guidance concerning the characteristics of transactions that may be caught, companies operating in the pharmaceutical sector will not find much comfort, as the characteristics will fit many transactions in the sector. These characteristics include transactions involving a target (i) with turnover/revenue that does not reflect its actual or future competitive potential or that is significantly lower than the consideration being paid to the seller, (ii) that is an important innovator or is conducting potentially important research, (iii) has access to competitively significant assets (such as raw materials, infrastructure, data or intellectual property rights), and/or (iv) provides key inputs/components. Pharmaceutical companies therefore are largely left to assess for themselves the practical risk of a transaction being subject to the expanded Article 22 procedure, taking into account possible challenges by competitors, customers, payors or suppliers, or an investigation initiated by a competition authority. Particular care is recommended for any transactions that could be politically sensitive or important to national health authorities or payors, which are more likely to be pursued by the competition authorities. The Illumina / Grail transaction provides a good example, as the case concerns next-generation gene testing for cancer, a topic that is important to the Commission’s Beating Cancer Plan. Negotiating Contractual Protections Deal terms will need to address this new risk of an Article 22 referral and merger review process, including the possibility of a decision imposing conditions or prohibiting the transaction. These terms will also need to address the possibility that a review could be initiated up to six months post closing, or even longer if the transaction raises serious competition law concerns. Informal Consultation with the Commission? The European Commission has indicated that it may be willing to provide informal guidance to parties concerning whether the transaction would likely be caught by the Article 22 procedure. However, as any guidance would be non-binding, the parties would only get very little legal certainty in the best scenario. For this reason, the main benefit from an informal consultation would arise where a transaction could raise substantive issues or is likely to be reviewed, in which case a pro-active approach would allow the parties to present their case and avoid that the authorities only hear from parties seeking to block the deal. Make the Transaction “Known” to National Authorities? Where a notification is not required in a Member State, the EU Merger Regulation specifies that national competition authorities may only refer the transaction to the Commission if the referral occurs within 15 working days from when the transaction is “otherwise made known” to the authority. This rule creates the opportunity for the parties to informally notify relevant national authorities of the transaction (so that the transaction is “made known” to the authority), and then await expiry of the 15-day period before closing the deal. Through such a step, the parties may achieve additional comfort that the transaction would not later face referral and review by the Commission after closing. However, the use and effect of such an informal notification remains untested, and may not be beneficial for all transactions. Currently, the law is not clear concerning what information would have to be provided to an authority for the transaction to be “made known”, and prevent a later referral after the expiry of the 15-day period. Further, the parties may incur significant costs and legal fees notifying authorities in all relevant countries. For these reasons, parties might instead choose to proceed without any informal notification or consultations, particularly where the transaction does not raise any significant substantive competition law issues and therefore is unlikely to face any later decisions requiring remedies or the unwinding of the deal. Influencing Whether the Commission Will Pursue an Article 22 Request The Commission’s Guidance indicates that the parties will be notified “as soon as possible” where a referral request is being considered. Parties to a transaction may therefore have a brief opportunity for informal submissions to the Commission and national authorities, seeking to convince the authority that the transaction does not merit referral. However, in light of the very short timelines available to the authorities to decide whether to refer a transaction, any opportunity for submissions and consultation would be very limited, and such measures are only likely to have an impact for simple transactions with no significant competition law concerns. Procedure if the European Commission Accepts the Referral If the Commission accepts a referral, the parties will be required to notify the transaction and the resulting review of the transaction will be largely governed by the standard EU merger review rules and procedures. As an exception, the “stand-still” obligation on the parties will only apply if the transaction has not already been implemented on the day on which the Commission informs the parties of a referral request from a national authority. New Opportunities for Third-Parties to Challenge Transactions While the expanded use of the Article 22 procedure creates significant risks for merging parties, it creates opportunities for competitors or other parties interested in challenging transactions. The European Commission’s guidance specifically welcomes third parties to “contact the Commission or the competent authorities of the Member States and inform them of a concentration that, in their opinion, could be a candidate for a referral under Article 22 of the Merger Regulation.” Suffice it to say, this creates a significant opening for any interested party to raise issues and introduce additional uncertainty for the parties seeking to complete or implement a transaction, even after closing.

    Read more
    • 07/05/2021
    • Articles

    European Commission Unveils EU Strategy for Covid-19 Therapeutics

    On 6 May 2021 the European Commission (the Commission) presented its EU Strategy for Covid-19 therapeutics (the Therapeutics Strategy or TS) (see, attached Commission press release, memorandum and fact sheet). The TS seeks to complement the EU Vaccines Strategy which the Commission unreservedly qualifies as “successful” (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020). It contains seven sets of structural measures designed to deliver therapeutics for patients affected by Covid-19, including people suffering from the long-term effects of the Covid-19 infection which are known as “long Covid”. These cover the following areas: • Research, development and innovation – Under the TS, the Commission will create a Covid-19 “therapeutics innovation booster” platform by July 2021 and support additional R&D. • Clinical trials – The TS will improve clinical trials in several ways, including the cooperation in safety assessment; the generation of high-quality safety data; the pre-authorisation assessment of clinical trials; and the building of capacity for high-grade material used in clinical trials. • Scanning for candidate therapeutics – The TS will expand the portfolio of promising therapeutics. • Supply chains and delivery of medicines – The TS will offer funding for various manufacturing initiatives. • Regulatory flexibility – The Commission will both maximise the effect of existing procedural possibilities, such as conditional marketing authorisations, and consider creating new avenues, including an EU emergency-use authorisation of medicinal products. • Procurement and financing – The Commission will enhance the capabilities of existing instruments such as the Joint Procurement Agreement for medical countermeasures and advance purchase agreements. Significantly, it also plans to create a fast-track pathway for the joint procurement of medical countermeasures. • International cooperation – The Commission will further engage with international partners and increase the assistance extended to affected third countries. In addition to announcing these structural measures, the Commission also makes the bold promise to authorise three new therapeutics by October 2021 and possibly two more by the end of the year.

    Read more
    • 28/04/2021
    • Articles

    Patent Settlements – What’s Next Following Lundbeck and Generics (UK)?

    The recent judgments by the EU Court of Justice in Lundbeck (citalopram), as well as the Court’s prior judgment in Generics (paroxetine), provide important clarity on the legality of pharmaceutical patent settlements under EU competition law. However, important questions remain unresolved. QUICK BACKGROUND The judgments in Lundbeck and Generics (UK) establish that patent settlements are unlawful if a generic supplier commits to delay or forgo market entry in exchange for an unjustified value transfer from an innovator. This principle applies even if there is the possibility that the generic supplier may infringe the innovator’s valid patent rights. In such a situation, the generic may be considered as a potential competitor if it has taken preparatory steps to enter the market (e.g. obtaining regulatory approval, sourcing stock of products and preparing a patent challenge), and any inducement to encourage such a potential competitor to cease its patent challenge and stay off of the market will likely violate EU competition law. OPEN QUESTIONS Is a settlement involving a license and royalty allowable? For innovators and generic suppliers seeking an alternative settlement structure to resolve disputes or uncertainty concerning patent validity or infringement, one option is for the innovator to grant the generic a license to enter the market prior to patent expiry, subject to the generic paying a royalty at a negotiated level. Such structures are, however, not without risk. In the still ongoing Servier case, the Commission decided that one such settlement was unlawful, but this decision was annulled on appeal to the General Court, and the issue remains to be addressed by the Court of Justice. When might a value-transfer to the generic supplier be allowable? Any value transfer to the generic supplier must not have the object of reducing or eliminating potential competition between the parties. The Generics (UK) judgment indicates that the following value transfers may be allowable: (i) reimbursement of costs of disruption caused by litigation, (ii) payment for actual goods or services, or (iii) reimbursement for discharge of prior undertakings given by the innovator (e.g. a cross-undertaking in damages). However, the Court takes care to note that any value transferred must “correspond in fact” to the justification, and thus must not be a disguised means of transferring additional (unjustified) value to the generic supplier. What is the impact of Brexit? Following Brexit, EU case law will no longer be binding on the UK competition authorities and courts, and it remains possible that they may adopt a divergent approach to that taken in the EU. The first illustration of this could occur in the Generics (UK) case, where the EU Court of Justice established the applicable legal principles to be followed (in a judgment two days before Brexit), but the case now reverts to the UK Competition Appeal Tribunal to apply the guidance to the specific settlements at issue in that case. As the first post-Brexit UK judgment on this issue of patent settlements, this new judgment by the CAT will be highly influential for the assessment of future settlements in the UK. Other Open Questions Many other open questions remain, as each patent settlement has unique features and context. Examples of further issues still to be resolved include: (i) settlements involving disputes on the validity of the compound patent (rather than the process patents at issue in Generics (UK) and Lundbeck) and (ii) the legality of pan-European settlements of complex patent disputes that might benefit competition in some countries while reducing competition in others. FUTURE ENFORCEMENT IN EU With the Generics (UK) and Lundbeck judgments, and the upcoming Servier judgment, the European Commission will have largely achieved its objective of establishing the legal principles governing reverse-payment patent settlements under EU competition law. Future enforcement actions concerning patent settlements will therefore likely shift to the national competition authorities of the EU Member States. The European Commission’s focus will likely shift to other topics, such as the new investigation launched against Teva concerning “misuse of patent procedures”.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *