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Adoption of New Procurement Regulations in the UK
By Jackie Mulryne, John Schmidt & Sofia Wilson on December 1, 2022
Posted in Healthcare, NHS, Procurement, UK Law
The procurement landscape in the UK is due to change next year. A draft procurement bill (Bill) seeks to consolidate a number of different procurement regulations that originate from EU legislation, including the Public Contracts Regulations 2015 (PCR), into a single revised regime. The aim is to modernise and unify procurement systems and processes into a single piece of legislation and to develop the regime specifically for England, Wales and Northern Ireland.
In addition to the Bill, a proposed Provider Selection Regime, introduced by regulations made under the Health and Care Act 2022, will create a new set of rules for arranging healthcare services in England, and take NHS healthcare services outside the scope of the Bill. That said, some services of relevance to the NHS may still fall under the Bill, in particular, the procurement of goods and medicines.
The aim of both the proposed Bill and the Provider Selection Regime is to give more flexibility to procurers to adapt the procurement process to the services and goods being procured, and to make it easier for the most suitable bidders to win the bid, while at the same time maintaining transparency. Neither the Bill nor the Provider Selection Regime apply in Scotland given that these are devolved matters and the pre-existing regime will remain in place there. Since the existing procurement regime originated in European law, there is currently little, if any, divergence between Scotland and the rest of the UK. The new changes will bring about the potential for divergence.
In this post, we have set out some key takeaways about the new procurement regime under the Bill and the proposed Provider Selection Regime. …
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UK Policy Paper on regulation of AI
By Jackie Mulryne, Peter Schildkraut & Eleri Williams on July 21, 2022
Posted in Medical Devices, MHRA, MHRA guidance, UK Law
There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply. These laws, such as the rules on data protection and medical devices, have to be adapted to specific AI technologies and uses. They sometimes overlap, which can cause confusion for businesses trying to identify the relevant requirements that have to be met, or to reconcile potentially conflicting provisions.
As a step towards a clearer, more coherent approach, on 18 July, the UK government published a policy paper on regulating AI in the UK. The government proposes to establish a pro-innovation framework of principles for regulating AI, while leaving regulatory authorities discretion over how the principles apply in their respective sectors. The government intends the framework to be "proportionate, light-touch and forward-looking" to ensure that it can keep pace with developments in these technologies, and so that it can "support responsible innovation in AI – unleashing the full potential of new technologies, while keeping people safe and secure". This balance is aimed at ensuring that the UK is at the forefront of such developments.
The government's proposal is broadly in line with the MHRA's current approach to the regulation of AI. In the MHRA's response to the consultation on the medical devices regime in the UK post-Brexit, it announced similarly broad-brush plans for regulating AI-enabled medical devices. In particular, no definition of AI as a medical device (AIaMD) will be included in the new UK legislation, and the regime is unlikely to set out specific legal requirements beyond those being considered for software as a medical device. Instead, the MHRA intends to publish guidance that clinical performance evaluation methods should be used for assessing safety and meeting essential requirements of AIaMD, and has also published the Software and AI as a medical device change programme to provide a regulatory framework with s a high degree of protection for patients and public.…
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The UK National Security and Investment Act 2021 (NSIA) – Implications for Life Sciences
By John Schmidt & Ludovica Pizzetti on June 21, 2022
Posted in Competition, Contract Law, UK Law
On 4 January 2022, after approximately four years from the UK government's first attempt to reform the UK national security screening regime, the National Security and Investment Act 2021 (NSIA) became operational. The NSIA represents a radical overhaul to investment screening in the UK as it introduces for the first time a mandatory and suspensory filing obligation for transactions in 17 sectors considered as particularly sensitive (among which are Synthetic Biology and Artificial Intelligence).
Alongside a mandatory and suspensory regime for certain transactions, parties are also encouraged to notify transactions voluntarily if—regardless of the sector concerned—the transaction might have national security implications based on (i) nature/identity of the acquirer, (ii) target's activities, and/or (iii) nature and degree of control acquired. Unlike the mandatory filing obligation which only captures acquisition of entities, the voluntary regime also captures the acquisition of tangible and intangible assets—thereby including the acquisition, assignment and/or licensing of IP rights over e.g. molecules, compounds, methods or technologies.…
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AI and IP: Implications for digital health from possible reforms to UK IP law
By Dr Beatriz San Martin & Shishu Chen on June 29, 2021
Posted in IP Law, Patent, SPC, UK Law
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.…
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Amendments to UK Human Medicines Regulations 2012
By Adela Williams on January 21, 2019
Posted in Falsified Medicines, Medicinal products, UK Law
On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012, was laid before Parliament. These regulations will come into force on 9 February 2019.
The principal purpose of the amendments is to transpose into UK legislation the remaining provisions of Directive 2011/62/EU (the Falsified Medicines Directive), which require two new safety features to appear on the packaging of certain medicinal products, and the associated Commission Delegated Regulation 2016/161/EU (the Delegated Regulation), which sets out the details of these features. However, the Amending Regulations have also introduced an important new provision allowing for "serious shortage protocols" (SSPs) to be put in place for prescription-only medicines (POMs) in certain circumstances, and have extended the types of product containing naloxone (indicated for the treatment of opioid overdose) that drug treatment services may supply in an emergency.…
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Brexhaustion: IP Rights and Exhaustion Post-Brexit
By John Schmidt, Richard Dickinson, Jackie Mulryne & Kathy Harford on December 11, 2018
Posted in Brexit, Exhaustion of IP rights, Patent, UK Law
On 28 November 2018, the UK Government published draft secondary legislation changing UK intellectual property law relating to exhaustion of IP rights to deal with Brexit. The aim is to ensure that the doctrine of EEA-wide exhaustion continues to apply in the UK post-Brexit, irrespective of whether there is a deal or a no-deal Brexit.
What is exhaustion?
As summarised in the explanatory memorandum, the exhaustion rule prevents the holder of an intellectual property right from using that right to stop the importation of a product into an EU country where it has been lawfully placed on the market in another country in the European Economic Area (EEA). In other words, an IP holder cannot use its IP rights to prevent parallel import (sometimes called grey imports) of goods from within the EEA. Unless the law is changed, this will not apply after Brexit, because the UK will no longer be part of the EEA. The proposed legislation seeks to change this so that exhaustion still applies to any goods brought into the UK, provided they have been placed on an EEA market with the IP owner's consent. This will apply irrespective of whether there is a Brexit deal or not, and it is intended that this comes into effect on Brexit-day, if approved by Parliament.…
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