Health
SI Title |
Laid Date |
Policy Area |
Summary |
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Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 |
19/11/18 |
Health |
This instrument amends the Blood Safety and Quality Regulations 2005 (S.I.2005/50) which operates in the field of blood and blood component safety and quality. It is made in exercise of the powers in the European Union (Withdrawal) Act 2018 to ensure the Blood Safety and Quality Regulations 2005 operate as intended following the withdrawal of the United Kingdom (UK) from the European Union (EU), if the UK leaves the EU in March 2019 with no agreement in place. Withdrawal from the EU without a deal would mean that the law in this area will no longer work as it is intended to. This is because it contains a number of references that will no longer be appropriate, such as references to obligations that UK is required to comply with as an EU Member State. As blood is a devolved competence, the legislation is being made on a UK-wide basis with the agreement of each of the Devolved Administrations (DAs) and will ensure continuity of the UK regulatory framework for the safety and quality of blood. |
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Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 |
19/11/18 |
Health |
The three Statutory Instruments (SIs) on the safety of organs, tissues and cells, and reproductive cells (gametes and embryos) for treating patients are ˜no deal' SIs. They have been developed as part of contingency planning and will be needed in the event that the United Kingdom (UK) leaves the European Union (EU) in March 2019 with no agreement in place; i.e. a ˜no deal' scenario. Withdrawal from the EU without a deal would mean that the law in this area will no longer work as it is intended to. This is because it contains a number of references that will no longer be appropriate, such as references to obligations that the UK is required to comply with as an EU Member State. Additionally, as the UK and EU Member States will consider each other to be third countries, amendments have been made to reflect this. The SIs are being made under powers in the European Union (Withdrawal) Act 2018 (referred to here as the EU (Withdrawal) Act). There are three separate SIs: the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜Tissues and Cells SI'; Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜HFE SI'; and the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜Organs SI'. The SIs are being made on a UK-wide basis. The Tissues and Cells and Organs SIs are being made with the agreement of each of the Devolved Administrations (DAs) and the HFE SI is reserved to Westminster. The SIs have been drafted separately as each amends different underlying legislation. The purpose of the SIs is to ensure that, in the unlikely scenario that the UK leaves the EU with no deal, the law in this area will still function properly and the UK regulatory framework for the safety and quality of organs and tissues and cells (including reproductive cells) is maintained. It is proposed that these SIs should be grouped and debated together. |
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Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 |
19/11/18 |
Health |
The three Statutory Instruments (SIs) on the safety of organs, tissues and cells, and reproductive cells (gametes and embryos) for treating patients are ˜no deal' SIs. They have been developed as part of contingency planning and will be needed in the event that the United Kingdom (UK) leaves the European Union (EU) in March 2019 with no agreement in place; i.e. a ˜no deal' scenario. Withdrawal from the EU without a deal would mean that the law in this area will no longer work as it is intended to. This is because it contains a number of references that will no longer be appropriate, such as references to obligations that the UK is required to comply with as an EU Member State. Additionally, as the UK and EU Member States will consider each other to be third countries, amendments have been made to reflect this. The SIs are being made under powers in the European Union (Withdrawal) Act 2018 (referred to here as the EU (Withdrawal) Act). There are three separate SIs: the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜Tissues and Cells SI'; Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜HFE SI'; and the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜Organs SI'. The SIs are being made on a UK-wide basis. The Tissues and Cells and Organs SIs are being made with the agreement of each of the Devolved Administrations (DAs) and the HFE SI is reserved to Westminster. The SIs have been drafted separately as each amends different underlying legislation. The purpose of the SIs is to ensure that, in the unlikely scenario that the UK leaves the EU with no deal, the law in this area will still function properly and the UK regulatory framework for the safety and quality of organs and tissues and cells (including reproductive cells) is maintained. It is proposed that these SIs should be grouped and debated together. |
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Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 |
19/11/18 |
Health |
The three Statutory Instruments (SIs) on the safety of organs, tissues and cells, and reproductive cells (gametes and embryos) for treating patients are ˜no deal' SIs. They have been developed as part of contingency planning and will be needed in the event that the United Kingdom (UK) leaves the European Union (EU) in March 2019 with no agreement in place; i.e. a ˜no deal' scenario. Withdrawal from the EU without a deal would mean that the law in this area will no longer work as it is intended to. This is because it contains a number of references that will no longer be appropriate, such as references to obligations that the UK is required to comply with as an EU Member State. Additionally, as the UK and EU Member States will consider each other to be third countries, amendments have been made to reflect this. The SIs are being made under powers in the European Union (Withdrawal) Act 2018 (referred to here as the EU (Withdrawal) Act). There are three separate SIs: the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜Tissues and Cells SI'; Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜HFE SI'; and the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 “ referred to here as the ˜Organs SI'. The SIs are being made on a UK-wide basis. The Tissues and Cells and Organs SIs are being made with the agreement of each of the Devolved Administrations (DAs) and the HFE SI is reserved to Westminster. The SIs have been drafted separately as each amends different underlying legislation. The purpose of the SIs is to ensure that, in the unlikely scenario that the UK leaves the EU with no deal, the law in this area will still function properly and the UK regulatory framework for the safety and quality of organs and tissues and cells (including reproductive cells) is maintained. It is proposed that these SIs should be grouped and debated together. |
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11/02/19 |
Health |
The European Union Directive 2011/24/EU on the application of patients' rights in cross-border healthcare (œthe Directive) sets out a framework of rules which allow patients to seek and pay for treatment in either the state or private sectors in another EEA country and have the costs of that treatment reimbursed by their home state. The obligation to reimburse is limited to treatment which is the same as, or equivalent, to a treatment that would be made available to the person in their home healthcare system, that is the NHS in relation to the UK, with reimbursement capped at the cost of state provided treatment in their home healthcare system. The Directive was implemented in Northern Ireland by the Health Services (CrossBorder Health Care) Regulations (Northern Ireland) 2013 (SR 2013 No.299)Following the UK's exit from the EU (œexit day), the Directive and the Treaty on the Functioning of the European Union will no longer apply in the UK. Therefore, the domestic legislation implementing the Directive will no longer be appropriate given that it is based on a reciprocal relationship with the EU of which the UK will no longer be a part. The amendments to the relevant domestic legislation will no longer allow a UK patient to seek and pay for treatment in either the state or private sectors in an EEA country and have the costs of that treatment reimbursed by the UK. It will also remove the obligation to provide National Contact Points (NCP) for the provision of information about treatment for incoming patients from an EEA country. The amendments will ensure that a patient whose treatment has commenced, or been authorised, on or before exit day will retain entitlement to Cross Border Health Care (œCBHC"). This instrument will also seek to ensure an orderly closedown, with transitional provision, of the rights enjoyed under the Directive. Where an EEA country enters a bilateral agreement with the UK to guarantee the status quo in relation to reciprocal healthcare, savings provisions will allow the Directive provisions to apply in those circumstances until 31 December 2020. |
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Healthcare (European Economic Area and Switzerland Arrangements) (EU Exit) Regulations 2019 |
03/10/19 |
Health |
This instrument makes provision for the purpose of implementing healthcare arrangements between the United Kingdom (UK) and European Economic Area (EEA) states, Switzerland (Member States) or an international organisation (for example, the European Union (EU)) after the UK leaves the EU in a no deal scenario. It also makes provision for the making of payments in respect of the cost of healthcare provided in Member States. It does this by conferring functions on certain bodies, including the NHS Business Services Authority (the NHS BSA), and requiring them to give effect to healthcare arrangements. The instrument also confers functions on the NHS BSA for the purposes of implementing any arrangements made with Member States to transitionally continue reciprocal healthcare provision under current EU Regulations which were continued by the Social Security Coordination (Reciprocal Healthcare) (Amendment etc.) (EU Exit) Regulations 2019 (the EU Exit Reciprocal Healthcare Regulations). |
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Reciprocal and Cross-Border Healthcare (Amendment etc.) (EU Exit) Regulations 2020 |
30/09/20 |
Health |
The purpose of this instrument is to address deficiencies in retained EU law relating to reciprocal healthcare in the UK and to make related provision. This instrument will ensure that the UK statute book will function correctly after the Implementation Period ( ˜IP ) and will make savings provisions to protect, so far as possible, certain patients in a transitional situation at the end of the Implementation Period. This instrument is made under powers in the European Union (Withdrawal) Act 2018 and the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019. |
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Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020 |
08/10/20 |
health |
On 31 January 2020, the United Kingdom (UK) left the European Union (EU). The Withdrawal Agreement agreed with the EU entered into force. The Ireland/Northern Ireland Protocol ( ˜the Protocol ) in the Withdrawal Agreement sets out the EU law that will continue to apply to and in Northern Ireland (NI) after the end of the Implementation Period. This includes the EU Blood Directive (2002/98/EC), EU Tissues and Cells Directive (2004/23/EC), and EU Organs Directive (2010/53/EU) (including the Commission implementing directives). This means that NI must continue to meet the requirements of the Directives for as long as the Protocol is in force. Four instruments make the changes needed to allow NI to meet these requirements. These four SIs are: the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020; the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020; the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020; and the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020. These four SIs have been drafted separately as each amends different underlying legislation but each one brings forward very similar provisions. It is proposed that these instruments are grouped and debated together. |
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Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 |
08/10/20 |
Health |
On 31 January 2020, the United Kingdom (UK) left the European Union (EU). The Withdrawal Agreement agreed with the EU entered into force. The Ireland/Northern Ireland Protocol ( ˜the Protocol ) in the Withdrawal Agreement sets out the EU law that will continue to apply to and in Northern Ireland (NI) after the end of the Implementation Period. This includes the EU Blood Directive (2002/98/EC), EU Tissues and Cells Directive (2004/23/EC), and EU Organs Directive (2010/53/EU) (including the Commission implementing directives). This means that NI must continue to meet the requirements of the Directives for as long as the Protocol is in force. Four instruments make the changes needed to allow NI to meet these requirements. These four SIs are: |
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Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020 |
08/10/20 |
Health |
On 31 January 2020, the United Kingdom (UK) left the European Union (EU). The Withdrawal Agreement agreed with the EU entered into force. The Ireland/Northern Ireland Protocol ( ˜the Protocol ) in the Withdrawal Agreement sets out the EU law that will continue to apply to and in Northern Ireland (NI) after the end of the Implementation Period. This includes the EU Blood Directive (2002/98/EC), EU Tissues and Cells Directive (2004/23/EC), and EU Organs Directive (2010/53/EU) (including the Commission implementing directives). This means that NI must continue to meet the requirements of the Directives for as long as the Protocol is in force. Four instruments make the changes needed to allow NI to meet these requirements. These four SIs are: |
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20/10/20 |
Health |
This instrument amends: The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775) (the 2019 Regulations); the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385) (the Second 2019 Regulations); the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744) (the Clinical Trials 2019 Regulations); and the Good Laboratory Practice Regulations 1999 (S.I. 1999/3106). The 2019 Regulations and the Second 2019 Regulations (together the 2019 SIs) and the Clinical Trials 2019 Regulations make significant amendments to the Human Medicines Regulations 2012 (S.I. 2012/1916) (the HMRs), the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) (the Clinical Trials Regulations) and the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190) (the Fees Regulations). Those amendments were intended to ensure that the Regulations were fit for purpose in a no deal EU Exit scenario. The HMRs, the Clinical Trials Regulations and the Fees Regulations will remain the basis for the regulation of medicines and clinical trials in Great Britain (GB) after 1 January 2021. This instrument amends the Regulations set out above in order that the HMRs, the Clinical Trials Regulations and the Fees Regulations will continue to be effective at the end of the Implementation Period for the purposes set out below. This instrument will amend how medicines and clinical trials will be regulated in Northern Ireland (NI) and in GB at the end of the Implementation Period, taking account the Northern Ireland Protocol (NIP). |
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The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 |
10/11/20 |
Health |
This SI supersedes the draft of the same title which was laid before Parliament and published on 15 October 2020. This instrument is required to ensure that the United Kingdom (UK) has a functioning statute book at the end of the implementation period (˜IP) and makes a number of amendments to other instruments for that purpose. The instruments this instrument amends are: 1. Medical Devices (Amendment etc.) (EU Exit) Regulations 2019/791 (the 2019 Regulations); 2. Schedule 2 to the Human Medicines and Medical Devices (Amendment)(EU Exit) Regulations 2019/1385 (the Amendment Regulations); and 3. Medical Devices Regulations 2002 S.I. 2002/791 (the Principal Regulations). These amendments are being made to ensure that the regulatory landscape is fit for purpose at the end of the IP. The amendments will also ensure the safety of UK patients through the continued supply of approved devices to the UK. |
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07/06/21 |
Health |
These Regulations are made in part in exercise of the powers in section 8(1) of the European Union (Withdrawal) Act 2018 (c.16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a) and (g) of that Act) arising from the withdrawal of the United Kingdom from the European Union. The retained direct EU law concerned relates to health security. Part 1 (starting with regulation 2) defines terms used in the Regulations. Regulation 3 identifies the bodies which are UK public health agencies for the purposes of the Regulations and makes provision about satisfying obligations under the Regulations where such an agency is also the UK focal point. Regulation 4 establishes a UK Health Protection Committee ('the Committee'). Regulation 5 sets out what constitutes a 'serious cross-border health threat'. Part 2 (starting with regulation 6) imposes an obligation on the UK public health agencies to carry out epidemiological surveillance on the communicable diseases and related special health matters listed in the Schedule in relation to their respective part of the United Kingdom. Regulation 6 also contains a power to allow the Secretary of State by regulations to amend the list of communicable diseases and related special health matters in the Schedule or to add or remove communicable diseases or related special health matters in respect of which epidemiological surveillance is to be undertaken. Regulation 6 adopts the case definitions for those diseases as contained in retained direct EU law on IP completion day. It also allows the Committee to create case definitions for new communicable diseases or related special health matters and to revise case definitions. Regulation 7 requires the Committee to establish procedures for collecting and sharing of information arising from epidemiological surveillance undertaken under this Part in order to harmonise and rationalise methodologies for such surveillance. It also requires the UK public health agency for England to provide quality assurance and to maintain databases in respect of such surveillance. Part 3 (starting with regulation 8) relates to procedures for dealing with serious cross-border health threats across the United Kingdom and liaison with the European Union. Regulation 9 requires the UK authorities to consult each other about preparedness and response planning for such threats. Regulation 10 requires UK public health agencies to notify alerts to the UK focal point immediately when such threats arise. Regulation 11 makes provision for coordinating responses to such threats. Regulation 12 relates to the sharing of information where there are alerts about serious cross-border health threats which are not communicable diseases or related special health matters. Regulation 13 is made under powers in section 31 of the European Union (Future Relationship) Act 2020 (c. 29) in order to implement the Trade and Cooperation Agreement between the United Kingdom and the European Union in so far as it relates to health security. Part 4 (regulation 14) makes provision about the regulations to be made under regulation 6(7) and (8). Part 5 (regulation 15) revokes the relevant retained direct EU law. |
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Medical Devices (Northern Ireland Protocol) Regulations 2021 |
16/06/21 |
Health |
This instrument relates to the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (EU MDR), which as of 26 May 2021 fully applies in Northern Ireland. The instrument updates existing legislation, makes provision for fees and ensures that enforcement provisions can operate properly in Northern Ireland. The instrument also implements areas of national decision allowed for within the EU MDR which will allow the regulatory framework in Northern Ireland to align with that of the rest of the UK where possible. |
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Nursing and Midwifery (European Qualifications) (Amendment) Regulations 2021 |
29/04/21 |
Health |
The purpose of this instrument is to address a deficiency in article 13 of the Nursing and Midwifery Order 2001 ('the NMO') (S.I. 2002/253), regarding recognition of professional qualifications ('RPQ'), that was introduced by an amendment made by EU Exit legislation (the European Qualifications (Health and Social Care Professions) (EFTA States) (Amendment etc.) (EU Exit) Regulations 2020 ('the Swiss Regulations') (SI 2020/1394). The deficiency is being addressed to ensure the UK regulator for nurses and midwives '“ the Nursing and Midwifery Council ('NMC')" can fully discharge its public protection function by ensuring that it has a legal basis for refusing admission to its register any individual who is not appropriately qualified. This instrument achieves this by putting back into effect a legal provision that ensures individuals are only eligible to apply for NMC registration on or after IP completion day if they (i) have a relevant qualification gained outside the UK and EU (Rest of World (RoW)) and that qualification was awarded within five years of the date of application, or (ii) they hold a relevant qualification gained within the UK or EU (regardless of when that qualification was awarded). |
Last updated 23 June 2021
