On 25 October 2018, the Court of Justice of the EU (CJEU) held in Case C-527/17 Boston Scientific that, where a medical device incorporates an ancillary drug substance, that substance will not be entitled to supplementary protection certificate (SPC) protection. That is the case even if the drug substance has been subjected to an evaluation of its safety, quality and efficacy that is analogous to the authorisation procedure for medicinal products, which are entitled to SPC protection.
Last week, the CJEU gave its decision in another procurement case in the healthcare area, Case C‑413/17 Roche Lietuva UAB. The case concerned the scope of technical specifications included as part of a tender by the Polyclinic for the Dainava District of Kaunas in Lithuania. The tender set out details of the medical diagnostic equipment and materials the authority wished to procure. Roche claimed that the specifications unreasonably restricted competition among suppliers due to their high specificity, and that in reality, the specifications corresponded to the products of certain manufacturers and excluded others.
The question referred to the Court concerned the limits to the margin of appreciation of a contracting authority to set out specifications in the tender, based on the quality of testing and the value of healthcare that it needs. The Court set out a useful summary of when technical specifications can be included in a tender and the principles for applying such specifications.
Earlier this month, the European Commission published a “rolling plan” for the implementation of the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). As we mentioned in our blog from last year, CAMD’s (Competent Authorities for Medical Devices) Implementation Taskforce published a high-level MDR/IVDR roadmap setting out how the Regulations will be implemented, and the order in which key guidance and clarification will be developed. Now, the Commission has published the rolling plan, which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play.
On 12 October 2018, the MHRA issued Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) providing guidance on the expansion of scope of the medical devices regime to include certain products which had been previously unregulated at EU level.
Article 1(2) of the Medical Devices Regulation (MDR), in force from 25 May 2017, explains that the MDR will regulate “certain groups of products without an intended medical purpose” as though they were medical devices.
There are currently six types of products in this category which are listed at Annex XVI of the MDR.
Last week, the European Court of Justice gave its judgment on certain procurement questions relating to the supply of a radiopharmaceutical product, referred by the Italian Court in Case C-606/17, IBA Molecular Italy Srl. An Italian regional health authority and a public hospital were seeking to award a substantial contract to a private hospital, without conducting a public tender. They argued that as no direct consideration was provided to the hospital, and as the hospital was “classified” as part of the public healthcare system, any award constituted an agreement between public authorities to which EU law on public procurement does not apply. The European Court disagreed, and concluded that (i) public authorities cannot circumvent the EU procurement rules by awarding “funding” to an organisation in return for the provision of free products, and (ii) it was not possible to treat a “private” hospital as a public hospital in order to award contracts to them outside the EU procurement rules.
From the information available about the case, the answers to the questions referred seem straightforward and may be limited to the Italian system. However, it is nonetheless useful to have confirmation from the Court on the extent to which the provision of healthcare falls within the EU procurement regime.
Yesterday, a new global medicines patent database, the Patent Information Initiative for Medicines (Pat-INFORMED), was launched by WIPO and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
Pat-INFORMED is designed to help procurement agencies better understand the global patent status of medicines, for example to anticipate generic launch and to design tenders. It includes a free open access database of patent information, and a platform where procurement agencies can make direct enquiries to companies. Continue Reading New global database for drug patent information
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently published a new version of its Code of Practice that will come into force on January 1, 2019, updating the current Code of 2012. IFPMA members, including the EFPIA and PhRMA, must incorporate the new provisions into their own codes by this date, to the extent necessary.
In addition to the text of the Code, the IFPMA has provided detailed guidance on the key amendments made. First, the Code is now underpinned by a guiding Ethos that replaces the previous iteration’s ‘Guiding Principles’. Secondly, several provisions have been updated, notably the section on gifts. We highlight the key changes below.
In July, we considered the implications of the UK Government’s Brexit White paper, setting out its proposals for the UK’s ongoing relationship with the EU post-Brexit and how this would apply to the supply and manufacture of medicinal products and medical devices. Acknowledging the need for a contingency plan if no agreement can be reached, the Medicines and Healthcare Regulatory Agency (MHRA) has now published guidance entitled “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal“. Below, we set out the key points arising from that guidance.
The regulation of medicines and medical devices in the UK is currently subject to both EU and UK legislation and oversight. For example, in relation to medicinal products, Directive 2001/83 and Regulation 726/2004, which govern marketing and supply in the EU, are implemented into UK law by the Human Medicines Regulations 2012 (HMR). For medical devices, Directives 93/42 (on medical devices), 98/79 (on in vitro medical devices) and 90/385 (on active implantable medical devices) set out the regulations in the EU, and are implemented in the UK through the Medical Devices Regulations 2002 (MDR). In addition, the new Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro medical devices) will apply from 2020 and 2022, respectively.
In the event of a no-deal Brexit, full regulatory authority will pass to the UK, and the European legislation will cease to apply to the UK on 29 March 2019 (exit day), although UK legislation that implements EU law will remain in force. Under the EU (Withdrawal) Act 2018 (EUWA), all existing EU rules will be converted into UK law at the moment of exit to the extent they are not already part of UK law.
Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way.
In response to early issues with the deployment of artificial intelligence and other algorithmic tools in healthcare, on 5 September 2018 the UK Department of Health & Social Care (DH) published an Initial Code of Conduct for Developers and Suppliers of Data-driven Health and Care Technology (the Code). The Code is not legally binding but aims to raise standards by establishing best practices.
Last week, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the European Commission, Parliament and EU Member States to extend the transition period under the Medical Devices Regulations (the MDR and the IVDR). As mentioned in one of our earlier blogs, the MDR and IVDR are due to take effect on 26 May 2020 and 26 May 2022 respectively. The position paper explains that the medical technology industry has “significant concerns” about the state of implementation of the Regulations, and the fact that if products are not re-certified before the date of application of the Regulations, they will not be able to be placed on the market, and the industry will be unable to provide life-saving and life-transforming products to patients. Continue Reading MedTech Europe requests extension to the transition period for the MDR