Instruments of interest
Draft Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019
Draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
Draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
49.These instruments are intended to ensure that after exit day, the current regulatory framework for the quality and safety of organs for transportation and tissues and cells (including reproductive cells) for human use is maintained so that UK establishments will continue to work to the same safety standards as they did prior to exit. For organ donation and transplantation, the NHS Blood and Transplant (NHSBT) (as the organisation responsible for organ donation and transplantation in the UK) and the Human Tissue Authority (HTA) (as the UK regulator for organs, tissues and cells other than reproductive tissues and cells) are working to ensure that written agreements are in place with EU organisations to allow organ exchange to continue post exit. NHSBT will be able to accept organs from EU countries from exit day provided that such organs can be traced from donor to recipient and meet quality and safety standards equivalent to that required in UK law. For tissues and cells, UK organisations (such as hospitals, stem cell laboratories, tissue banks and fertility clinics) which undertake licensable activities27 are regulated by the HTA and the Human Fertilisation and Embryology Authority (which regulates reproductive tissues and cells). At present, licences are only required for imports and exports with non-EU countries. In the event of ‘no deal’ with the EU, the EU and the UK would consider each other to be “third countries” and these Regulations will amend existing licences to allow imports and exports with EU countries. The Department of Health and Social Care (DHSC) has explained that “no current establishments will need to apply for an import/export licence, so there will be no additional burden.”28 However, UK organisations would need written agreements with the relevant EU licensed establishments to continue importing or exporting. DHSC estimates that “12 establishments (non-reproductive cells) will need to do this, mostly privately operated small businesses. And that each one will need between 1 and 5 new agreements.” It estimates that “for reproductive cells, 60-120 new agreements may be needed but can’t say how many establishments this would be.” The Regulations set out that UK establishments will have a transitional period of six months to comply “to allow UK licensed establishments that import tissues and cells from EEA states to put in place new agreements or amend existing ones, to comply with the requirements in the legislation.”
Draft Interchange Fee (Amendment) (EU Exit) Regulations 2018
50.The EU Interchange Fee Regulation (IFR) of 201529 set caps on the level of consumer card payment interchange fees (fees paid by a merchant’s acquirer30 to a card issuer31 every time a consumer debit or credit card is used to purchase a good or a service) and imposed a number of business rules on card schemes, card issuers, acquirers and merchants. In the Explanatory Memorandum (EM) to these draft Regulations, HM Treasury (HMT) says that, as regards the interchange fee for domestic debit card transactions, the cap is set at 0.2% of the value of the transaction; and for credit card transaction fees, at 0.3% of the value of the transaction.
51.The Regulations propose amendments to ensure that the IFR continues to operate effectively within the UK after the UK leaves the EU, mainly by reducing the scope of application of the IFR in UK legislation from the EEA to the UK. This would mean that transactions which took place solely within the UK (where acquirer and card issuer are both located in the UK) would continue to be covered by the IFR, but cross-border card payments between the UK and the EU would no longer be within scope of either the retained UK Regulation or the EU IFR.
52.We sought information from HMT about the additional costs that might result to businesses and consumers from reducing the scope of the Regulation to the UK only: we are publishing HMT’s response as Appendix 3. HMT has also told us that it intends to revise section 12 of the EM on impact: in line with Better Regulation guidance, it considers that the net impact on businesses will be less than £5 million a year and has carried out a de minimis assessment, but will not publish a full Impact Assessment. We find it disappointing that HM Treasury provides so little detail about the financial impact of the changes proposed.
Nursing and Midwifery Council (Fees) (Amendment) Rules Order of Council 2018 (SI 2018/1198)
53.From 28 January 2019, the Nursing and Midwifery Council (NMC) will be able to register Nursing Associates (NA) whose role has been developed as a bridge between healthcare assistants and registered nurses. It will act as a stand-alone profession, as well as a new route to becoming a registered nurse. Health Education England (HEE) established two pilot groups in January 2017 (approximately 1,000 students) and April 2017 (approximately 1,000 students) of NA trainees, who are due to complete their training in early 2019. In October 2017, plans were announced for up to 5,000 additional NAs to commence training on HEE pilot cohorts through the apprenticeship route in 2018, with up to 7,500 a year thereafter. The NMC will regulate this new group, who will be required to have the right standards of proficiency, keep their skills and knowledge up to date, and be accountable for their standards of practice and behaviour. Any questions over their fitness to practise will be considered by the NMC in the normal way. The fee structure for NAs mirrors the registration fee structure for nurses and midwives: £120 to join the register with a renewal fee of £120 per year.
27 Such as procurement, testing, processing, storage, distribution, import and export.
28 However, future new establishments that intend to import or export that do not already hold a HTA or HFEA licence will need to apply for one.
29 Regulation (EU) 2015/751 of the European Parliament and of the Council of 29 April 2015 on interchange fees for card-based payment transactions (OJ L 123/1, 19 May 2015).
30 That is, the Payment Service Provider which enables the merchant to accept card payments.
31 That is, the Payment Service Provider which issued the cardholder’s card.