The UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the US Food and Drug Administration (FDA) and Health Canada have recently published a joint statement identifying ten guiding principles to help inform the development of Good Machine Learning Practice (GMLP).  The purpose of these principles is to “help promote safe, effective, and high quality medical devices that use artificial intelligence and machine learning (AI/ML)”.

The development and use of medical devices that use AI and ML has grown considerably over the last few years and will continue to do so. It has been recognised that such technologies have the potential to transform the way in which healthcare is deployed globally, through the analyse of vast amounts of real-world data from which software algorithms can learn and improve. However, as these technologies become more complex and nuanced in their application, this brings into question how they should be overseen and regulated. Crucially, it must be ensured that such devices are safe and beneficial to those who use them, whilst recognising associated risks and limitations.

Continue Reading Ten International Guiding Principles on Good Machine Learning in Medical Devices

In May 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance (Draft Guidance) addressing the requirement for all investigators involved in clinical trials conducted under a U.S. Investigational New Drug (IND) application to sign Form FDA 1572. This includes investigators in clinical trial sites outside the U.S.

By signing Form FDA 1572 (Form 1572), the investigator of a drug or biologic trial warrants that they and any listed staff have the experience and background needed to conduct the trial and agrees to comply with the protocol and all applicable U.S. regulatory provisions governing the conduct of clinical trials.  From an FDA standpoint, it provides a clear basis of responsibility (and potential liability) under the applicable clinical trial regulations (21 CFR 312) for those who sign the form.  It also raises questions about the extent of FDA’s extraterritorial reach over non-U.S. investigators who conduct IND studies outside of the United States.

Continue Reading FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US

Following increasing pressure from industry and patient groups alike, yesterday (14 October) the European Commission published its proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) by amending the transitional provisions for certain products. The Commission noted that the COVID-19 pandemic has hampered the capacity of Member States, health institutions and companies to comply with the new requirements in time for the current deadline of May 2022, and that the “serious shortage of notified body capacity, mak[es] it impossible for manufacturers to conduct the legally required conformity assessment procedures in time”. As such, the proposal provides industry and patients some much needed relief, and aims to avoid a large number of products that are already on the market being discontinued in May due to non-compliance.

While the proposal still needs to go through the EU legislative procedure, it seems likely that the amendment will be adopted before the current date of application of May 2022. It is also important to note that the delay does not apply uniformly to all IVDs, as set out below.

Continue Reading European Commission proposal to delay application of In Vitro Diagnostics Regulation

On 28 September 2021, the European Commission took another step in the implementation of its  new pharmaceutical strategy (discussed in more detail in our previous blog posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response).

As part of its work on the revision of the EU pharmaceutical legislation, the Commission launched a dedicated public consultation. The purpose of this consultation is to gather views and information to support the Commission’s impact assessment for the revision of the EU pharmaceutical legislation. This is, therefore, a good opportunity for all stakeholders to share their views and concerns, as well as their vision for the future EU pharmaceutical legislation.

The consultation is open until 21 December 2021 and seeks the views of all stakeholders on key issues such as:

Continue Reading European Commission launches consultation on reform of EU pharmaceutical legislation

On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the MHRA intends to “establish a new medical devices legislative framework for the UK to support safe innovation and ongoing access to products”.

The current framework for medical devices in the UK is set in the Medical Devices Regulation 2002, which implemented the EU Medical Devices Directives. However, the EU regime has now been substantially updated by the Medical Devices Regulations. Whilst the new Medical Device Regulations 2017/745 have been applicable in the EU since 26 May 2021, they do not apply in Great Britain and have not been implemented into UK law. The Regulations will, however, apply in Northern Ireland under the terms of the Northern Ireland Protocol. Similarly, the In Vitro Diagnostic Medical Devices Regulations 2017/746, due to apply in the EU from 26 May 2022, will not apply in Great Britain, but will apply in Norther Ireland.

The MHRA was heavily involved in the development of the new EU legislation and believed in the need to update the current Medical Device Directives and the UK Regulations. There have been concerns that as the updates to the EU regime do not apply in Great Britain, the UK may be seen as a less attractive country in which to develop and market medical devices, or that it does not protect patients to the same extent.

As such, the consultation focuses on patient safety and innovation (which are not mutually exclusive) whilst recognising that gaining and maintaining competitiveness in a global market will best be supported by alignment with internationally recognised best practice and standards, including greater alignment with the new EU Regulations.

Continue Reading Consultation on framework for medical devices in UK

After a public consultation last July, the EMA published its Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders (MAH) on 23 July 2021. The Paper aims to clarify the responsibilities of the MAH in the GMP guidelines and the applicable legislation. While it is not legally binding, the EMA expects competent authorities to use the Paper as guidance when performing inspections, and so MAHs should familiarise themselves with the document. In this blog we have summarised the key takeaways. Continue Reading EMA Reflection Paper on Good Manufacturing Practices and Marketing Authorisation Holders

We discussed in previous posts the Commission’s announcement at the end of 2020 of its new pharmaceutical strategy for the EU. One topic identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines.  We have previously discussed recent consultations and stakeholder engagements by the Commission to explore possible changes to the legislative regime in these areas, including the possibility of reducing the ten-year market exclusivity period for orphan medicines and changing the criteria for determining the rarity of a disease.

Following the responses to these consultations, in May 2021, the Commission launched its latest public Consultation on the proposed revisions to the legislation.  The Commission’s statement accompanying the launch asserts that its evaluation “revealed shortcomings in the current system concerning in particular the development of medicines in areas of high unmet need for patients and their accessibility to all EU patients across the Member States.” Industry bodies representing the innovative pharmaceutical industry have now published their responses to the Consultation, as summarised below. Continue Reading Industry’s response to the Commission’s proposed amendments to the EU orphan and paediatric legislation

On 7 July 2021, the European Data Protection Board (EDPB) adopted the final version of its guidelines 07/2021 on the concepts of controller and processor in the General Data Protection Regulation (GDPR) (Guidelines), following a period of public consultation regarding the first draft of the Guidelines (about which we reported in an earlier blogpost). As discussed below, the final Guidelines have considerable significance for the life sciences sector.

Another key GDPR development that is directly relevant for the life sciences sector and international transfers of personal health data (e.g., conduct of cross-border clinical trials) is the adoption of the new version of the standard contractual clauses (New SCCs) published by the European Commission (EC) on 4 June 2021. The second part of this blogpost outlines some key takeaways of the New SCCs. (We provide a more detailed analysis of the design, scope and main content of the New SCCs in our related advisory.)

Continue Reading Recent GDPR developments relevant for the life sciences sector

As we have discussed in previous posts, at the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). In 2021, the Commission has begun to implement the new Strategy, as discussed here. One area that was identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines. The Commission has been focused on this area for a number of years, and there have been a number of consultations and stakeholder engagements to explore possible changes to the legislative regime. We set out below a summary of the Commission’s proposals on orphan and paediatric medicinal products.

Continue Reading European Commission’s proposed amendments to orphan and paediatric legislation

The use of artificial intelligence (AI) and machine learning is growing at a significant pace and  spreading across many industry sectors, including healthcare. With the rapid development of AI technology which has the potential to revolutionise many aspects of our lives, including in providing and receiving healthcare services, the concept of “creations of the mind” is no longer limited to creations by a human being. These technological developments mean that the legal framework governing intellectual property (IP) rights such as patents and copyright, which protect “creations of the mind”, may need to be adjusted to address the changes and impacts brought about by the use of AI.

In line with the UK government’s ambition for the UK to be a leader in AI and to better understand the implications AI might have for IP policy, as well as the impact IP might have for AI in the short to medium term, the UK IPO conducted a public consultation at the end of 2020. The aim of the consultation was to seek responses on a range of questions relating to AI and IP rights. The UK IPO received 92 responses from a wide range of stakeholders, including IP rights holders, producers of AI technology and academia. The government’s response to the call for views on AI and IP was published in March 2021, under which reforms to patent and copyright law and policy were discussed.

In this blog, we summarise the UK government’s conclusions from the consultation before considering the potential impact to digital health applications and companies.

Continue Reading AI and IP: Implications for digital health from possible reforms to UK IP law