Our first edition of 2022 focuses on Healthcare and Life Sciences. It is a sector that will once again have the spotlight on it this year as we continue to tackle COVID-19 and its subsequent variants. While the pandemic continues to challenge the sector, governments across the region forge ahead with their plans to expand and upgrade healthcare systems and develop robust world-class healthcare infrastructure.
For the region, healthcare is a vital pillar in diversifying its economies, both locally and as medical tourism hubs. To underpin this, healthcare authorities across the region continue to implement frameworks and regulations that provide structure and accountability.
In this edition, you have unique access to great insights and expert commentary on a number of pertinent healthcare regulatory developments. You will find a topical mix of articles; for example, our lawyers discuss vaccines and returning to work during the pandemic. They take you through several other areas, including stem cell research in Bahrain, clinical research laws in Egypt, and Saudi medical device and pharmaceutical laws.Take a read of the edition
Margaret Elder - Senior Associate - Banking and Finance
New Intermediate SPV Vehicles
The DFSA and DIFC held a joint seminar on 31 October on structuring and the new ‘Intermediate SPV’ regime with the focus being on fund structuring. (‘Intermediate’ referring to such vehicles sitting in an intermediate position in a structure).
The Intermediate SPV is a recent development by the DIFC Authority which provides a cost effective option for establishing SPVs in the DIFC (i.e., only US$1,000) not just in respect of fund structures but across the board.
There has been the option to establish Special Purpose Companies in the DIFC previously, and this option remains, but these are comparatively expensive and process-heavy to set up. The new Intermediate SPVs will be cheaper and easier to establish. No change of law or rules has occurred as yet, but the entities are available now through standardised waivers which will apply when an application is made to the DIFC Authority.
However, the Intermediate SPVs will only be available to entities that already have a substantive presence in the DIFC (i.e., fund managers, asset managers, family offices etc).
This development is a step closer to what the ADGM offers by way of SPVs and will make life easier and cheaper as far as structuring options go for existing DIFC entities, but doesn’t go quite as far as the ADGM regime due to the requirement to already have a substantive DIFC presence.
Amendments to DFSA Legislation
On 22 June 2016, the DFSA published a notice of amendments to the DFSA Rulebook based on the changes proposed in consultation paper 103 and consultation paper 105. This includes changes to the insurance regime, the AML Annual Return deadline and stipulations for communications with the DFSA. These amendments came into effect on 1 August 2016.
Changes to the insurance regime
The recent amendments have provided for the below changes to the DFSA’s insurance regime:
Online Applications and Submission of Data to the DFSA
The legislative changes that were set out in Consultation Paper No.105 have now been implemented. Essentially the DFSA intend to increase the range of transactions, and interactions, which can take place online. The DFSA will introduce an online portal that will allow entities and individuals to submit electronic data directly to the DFSA. The portal will be accessible from the DFSA website, in the same way as is currently the case for the Electronic Prudential Reporting System.
In the first phase of work, which is intend to be complete by the end of 2016, various DFSA authorization application forms and the Annual AML return will be made available through the online portal.
Additionally, the timing of submission of the annual AML return has changed. Instead of being due four months’ after the end of the Relevant Person’s financial year, this return will in future be due by the end of September each year and the report must cover the period from August of the previous year up to and including July of the lodgement year.
Authorised Firm conducting prohibited insurance activity in the UAE
On the 21 September 2016 the DFSA issued a Decision Notice and imposed a fine of USD 85,191 on an Authorised Firm, who is licensed to provide the Financial Service of Insurance Intermediation. The fine was imposed following a DFSA investigation conducted in collaboration with the United Arab Emirates Insurance Authority.
Under the DFSA Rulebook Authorised Firms are prohibited from intermediating a Contract of Insurance for a risk situated in the UAE unless:
The DFSA’s investigation identified that the Authorised Firm intermediated contracts of Insurance for customers with risks situated in the UAE and outside the DIFC, which were not contracts of re-insurance in breach of the abovementioned DFSA Rules. The Authorised Firm also and failed to have adequate systems and controls in place to detect, monitor and prevent such activities from occurring.
DFSA concerns over Authorised Firm’s AML systems and licensed activities
On the 18 of October 2016 the DFSA accepted an Enforceable Undertaking from an Authorised Firm as a result of the DFSA concerns about the firm’s anti-money laundering systems and controls, and about whether it had carried out the Financial Service of Providing Custody to its clients without being licensed to do so. Although the firm did not agree with the DFSA’s findings, it acknowledges the DFSA’s concerns and agrees to engage an independent expert to ensure that the concerns are remedied.
The firm also agreed to pay a financial penalty of USD 60,000 to the DFSA of which USD 30,000 is payable on or by 17 November 2016. The remaining USD 30,000 is suspended indefinitely and becomes payable if the firm fails to comply with the Enforceable Undertaking.
Future Amendments to DFSA Legislation
To complete our summary of regulatory updates in the DIFC, we also feel is of importance to mention the following proposed amendments to the DFSA Rulebook that have been addressed in the below listed consultation papers. Please note all three of these consultation papers have finished their consultation period and the proposed amendments to the DFSA Rulebook will be implemented when the relevant Rulemaking instruments are issued by the DFSA. Below is a summary of the changes that each Consultation paper has proposed.
Please note the proposed changes will not come into force until the relevant Rulemaking instrument has been published by the DFSA and please also be aware that the proposals contained within the consultation papers may change. Therefore ultimately only the text of the amended Rulebook and/or Law as published in the Rulemaking instrument can be relied upon.
Consultation paper 106
The DFSA issued Consultation paper 106 due to what they felt was a lack of clarity in some areas of regulation. Therefore Consultation paper 106 proposes to provide greater clarity to the meaning and scope of ‘arranging’ related Financial Services, Operating a Representative Office and the Financial Promotions regime.
In summary, the Consultation paper proposes to make the following changes:
1. ‘Arranging Deals in Investments’ and ‘Dealing in Investments as Agent’; and
2. ‘Arranging Custody’ and ‘Providing Custody’.
In light of the above proposals, when they come in force, some Authorised Firms may need Licences for a different type of activity than they currently hold. It is proposed that the DFSA would generally allow a period of six months for the firms to complete the necessary formalities to obtain the right type of Licence. Representative Offices and persons carrying out Financial Promotions which act beyond the scope of their Licences or of the DFSA Rules, as would be clarified under these proposals, would need to cease such activities immediately.
Consultation paper 107
In consultation paper 107, the DFSA is proposing changes to the Anti-Money Laundering, Counter-Terrorist Financing and Sanctions Module (‘AML Module’) in order to make sure that the regime remains up-to-date in light of the 2012 Financial Action Task Force Recommendations and the recent amendments made to the UAE Federal Law No.4 of 2002 and other UAE AML Legislation.
In summary, the Consultation paper proposes to make the following changes in the AML Module:
Consultation paper 108
In consultation paper 108 the DFSA is proposing amendments to the capital requirements for managers of collective investment funds and amendments to the rules regarding reporting suspicions of market abuse.
In relation to capital requirements for managers of collective investment funds, it is proposed to leave the required expenditure based capital minimum as it is. However the DFSA proposes to reduce the Base Capital Requirement for: a) managers of Public Funds to USD 140,000; and b) managers of Exempt Funds and QIFs to USD 70,000.
An obligation to report suspicions of market abuse to the DFSA is currently imposed on market operators (i.e. Operators of Authorised Market Institutions and of Alternative Trading Systems). However there is not an explicit obligation on Authorised Firms to report suspicions of market abuse by others for whom the firm may be acting. Therefore the DFSA proposes to amend the DFSA Rulebook so that Authorised Firms and Recognised Members are under an explicit obligation to report suspicions of market abuse to the DFSA.