Publication
New rules for MDEL holders: Health Canada’s terms and conditions authority
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
United Kingdom | Publication | December 2024
In March 2023 we published an article providing some background on the designated activities regime (DAR) and how it will impact firms1. In this article, we continue to explore some of the key issues, with a particular focus on supervisory approach and enforcement.
The DAR is a framework for the regulation of certain activities relating to financial markets which are currently unregulated. It was established through amendments to the Financial Services and Markets Act 2000 (FSMA) made by the Financial Services and Markets Act 2023 that came into force on 29 August 2023.
The DAR itself is due to come into force in a number of tranches – currently, of the regimes covered by this article, only the Securitisation Regulations are currently in force (as of 1 November 2024). The remaining Regulations will likely come into force within the next 12-24 months.
The DAR provides a mechanism for HM Treasury and the FCA to regulate certain activities relating to financial markets that are typically carried out by non-financial institutions as well as by financial services firms. Under the regime, persons carrying on certain designated activities will need to comply with requirements and rules specified by HM Treasury and the FCA, unless they benefit from an exemption. However, persons carrying out designated activities will not be required to obtain authorisation as a condition of carrying on the activity.
Each set of designated activities has a different territorial approach – whilst in some instances firms will only be considered to be conducting designated activities if they do so from a UK establishment, in others cases firms will be caught wherever they are in the world if there is a ‘link’ to the UK (e.g. if the activity relates or is connected to a) financial markets or exchanges in the UK or b) financial instruments, financial products or financial investments that are (or are proposed to be) issued or sold to, or by, persons in the UK).
We set out below, a list of those “designated activities” listed as such in legislation that has been published to date.
Regime | Legislation status | Status of FCA rules | Designated activities |
UK Benchmarks Regulation ((EU) 2016/1011) |
To date, HM Treasury has not published any draft legislation relating to the designated activities. |
Look to existing rules at this stage. |
HM Treasury is considering using the designated activities regime to establish new designated activities relating to benchmarks. It indicated in Schedule 6B to FSMA that the following activities, which presumably reflect activities set out in the UK Benchmarks Regulation ((EU) 2016/1011), will be designated:
|
Derivatives |
To date, HM Treasury has not published any draft legislation relating to the designated activities. |
Look to existing rules at this stage. |
HM Treasury is considering using the designated activities regime to establish new designated activities relating to derivatives.
|
Consumer composite investment (CCI) (note: this replaces the existing PRIIPS regime) |
The Consumer Composite Investments (Designated Activities) Regulations were made on 21 November 2024.2 |
The FCA is yet to publish a consultation on its rules, although the consultation was previously expected in Q4 2024. |
|
Public offer and admissions to trading |
The Public Offers and Admissions to Trading Regulations 2024 were made on 29th January 2024.3 |
The FCA has published 2 consultations in relation to the new Public Offer regime, both of which closed on 18 October 2024.4 |
In relation to the public offers of relevant securities, the designated activities are:
In relation to admissions to trading on a regulated market the designated activities are:
In relation to admissions to trading on a primary multilateral trading facility (MTF) the designated activities are:
|
Securitisation |
The Securitisation Regulations 2024 were made on 29th January 2024.5 |
In April 2024, the FCA published its Policy Statement following an earlier consultation on rules relating to securitisations.6 |
|
Short selling |
An updated version of the draft Short Selling Regulations 2024 were published on 11 November 20247 and have been laid before Parliament. |
The FCA is yet to publish a consultation on its rules. |
|
Depending on the approach taken by HM Treasury in relation to a specific activity, the consequence of it being designated will be one of the following:
To date, HM Treasury has not used the DAR to prohibit the performance of any particular designated activities.
Each designated activity will have its own framework for supervision and enforcement to be set out in relevant designated activity regulations, taking into account the relevant provisions of FSMA.
The FCA has a power of direction imposing requirements specific to a firm or a group of firms relating to the carrying out of designated activities (e.g. to take or refrain from taking a specified action) under Section 71O of FSMA, if provided for in HM Treasury regulations. A direction or notice must be given in writing to the person or persons to whom it applies. But the FCA has the power, in the circumstances the FCA considers it appropriate, to publish the direction or notice in the way that the FCA considers to be best calculated to bring it to the attention of persons likely to be affected by it.
Each Regulation specifies the way in which directions can be given and the extent to which that power is available to the FCA in relation to a particular designated activity. The Regulations also set out the FCA’s powers in relation to persons knowingly concerned in a contravention of the relevant Regulations, including a direction given under section 71O of FSMA – such powers include public censure and issuance of financial penalties.
Designated activity regulations may also contain provisions:
Unless set out in the designated activity regulations, a breach will not:
On 11 November 2024, the draft Financial Services and Markets Act 2000 (Designated Activities) (Supervision and Enforcement) Regulations 20248 were laid before Parliament. Once finalised, these regulations will provide the FCA with powers to supervise designated activities by gathering information and launching investigations into persons carrying out designated activities, and to enforce its designated activity rules by publicly censuring or imposing financial penalties on persons that breach them. This instrument does this by extending the FCA’s existing supervision and enforcement powers under FSMA 2000 so they can be used in relation to designated activities. The Regulations also set out the procedures that will apply to the giving of directions by the FCA relating to designated activities.
Whilst we await final legislation to be passed as well as rules from the FCA to be finalised, firms can be taking steps to prepare themselves for the DAR coming into force, including by:
Publication
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
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