Blake Morgan’s Health Sector legal experts have put together a round-up of the latest news within the area.
Welcome to the review of the January edition of Health Sector News, a digest of legal issues hitting the headlines in the health sector.
High Court quashes the suspension of NHS pensions prior to conviction
R. (on the application of British Medical Association) v Secretary of State for Health and Social Care  EWHC 64 (Admin)
The British Medical Association (BMA) applied for judicial review after the Secretary of State for Health made amendments to the NHS England Pension Scheme through the National Health Service Pension Schemes, Additional Voluntary Contributions and Injury Benefits (Amendment) Regulations 2019 (the 2019 Regulations).
Prior to the amendments the Secretary of State had the power to forfeit a pension after a member of the scheme was convicted of a specified criminal offence committed before the pension became payable. The amendments confer an additional power to suspend payment where a person is charged with certain very serious offences. There are no provisions, which would allow a person to whom the new suspension power applies, to appeal the suspension, and suspension would not automatically terminate upon acquittal or other circumstances where forfeiture would not be applicable.
The BMA argued that the suspension power is a breach of Article 14 (which prohibits discrimination on the grounds of status), read with Protocol 1 Article 1 (peaceful enjoyment of one’s own possessions), and lacks procedural safeguards under Article 6 of the European Convention on Human Rights (ECHR).
The High Court held that terms of the suspension power was not compatible with the presumption of innocence and there was no evidence that anyone had considered how the suspension power might impact on the presumption of innocence.
The rationale of the forfeiture power is that a person who has committed a serious criminal offence through their public sector position should not then receive a public sector pension. There was no reason to see why the public would find it scandalous to continue to pay a pension to someone who had merely been charged (and presumed innocent) with an offence, therefore there was no justification for extending the power of forfeiture to suspend on charge alone.
The power was inherently unfair in that it would subject pensioners to an immediate detriment which would not apply to those still in work who were also charged with similar offences. For this reason the Secretary of State had also not fulfilled the public sector equality duty under section 149 of the Equality Act 2010, as no consideration was given to the disproportionate impact the suspension power would have on the elderly and disabled.
The suspension power was also incompatible with Article 6 of the ECHR as individuals have no ability to make representations before the decision is made and payments suspended, the decision maker is not impartial and the decision making procedure is not done with administrative expertise and they cannot apply the presumption of innocence.
The suspension power was not justifiable and therefore the High Court granted the relief sought and quashed the relevant provisions of the 2019 Regulations.
The Welsh Government’s proposed National Health Service (Pharmaceutical Services) (Wales) Regulations 2020
The Welsh Government has carried out a consultation on pharmaceutical services and published the summary responses to the consultation in January 2020.
The draft National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (the “2020 Regulations”) would introduce a requirement for local health boards to conduct and publish a pharmaceutical needs assessment for its area and to consider applications to provide NHS pharmaceutical services on this basis.
It is intended that pharmaceutical needs assessments will improve the delivery and planning of services by ensuring that health boards consider the needs of their populations and that the services align with those needs. The assessments should be able to determine where additional pharmacies are needed or additional services are needed from existing pharmacies. It is envisaged that this will also be beneficial to pharmacies who will have more certainty as to the demand for their services. The proposals are also intended to improve the quality and the consistency of pharmacy services.
The pharmaceutical needs assessment will include: current service provision, gaps in service provision, dispensing services, other NHS services, an explanation of how the assessment was made, and a map identifying where pharmaceutical services are currently being provided. The first pharmaceutical needs assessment would have to be published by each health board within 6 months of the 2020 Regulations coming into force, and each subsequent assessment must not be published more than 5 years after the previous one. Various bodies such as local authorities, NHS Trusts, Local Pharmaceutical Committees must be consulted on the contents of the assessments, and the parties will have 60 days in which to challenge and comment on the findings.
The 2020 Regulations would replace the National Health Service (Pharmaceutical Services) (Wales) Regulations 2017.
Parties who responded to the Consultation raised queries surrounding online pharmacies and pharmacies in England in border areas, timings for the first pharmaceutical needs assessment and scenarios where re-assessment would be required.
To view the draft 2020 Regulations, the Consultation document or the summary of responses, please go to: https://gov.wales/national-health-service-pharmaceutical-services-wales-regulations-2020
National Health Service (Indemnities) (Wales) Bill 2019
On 14 January 2020 the Assembly agreed the National Health Service (Indemnities) (Wales) Bill 2019 (the Bill), leaving only the final Assembly vote before the Bill becomes law.
The Bill makes amendments to the National Health Service (Wales) Act 2006 to make provision for indemnities in respect of expenses and liabilities arising in connection with the provision of health services in Wales.
Section 30 of the NHS (Wales) Act 2006 allows Welsh Ministers to make regulations to establish indemnity schemes whereby health service bodies collectively pay in to meet their liabilities. The Bill expands the scope of potential indemnity schemes to all persons providing, or who have provided, primary medical services in Wales in accordance with an NHS contract, and to persons providing, or who have provided health services, in accordance with a contract with a Local Health Board, NHS Trust or Special Health Authority.
The priority of the Bill is to provide indemnity to GPs, whose indemnity payments to Medical Defence Organisation (who provide indemnity cover for medical practitioners) are increasing, leading to GPs reducing their hours in order to reduce their indemnity payments, which may lead to a further shortage of GPs. The Bill will allow Welsh Ministers to bring the indemnity scheme in line with that being enacted in England to ensure that Welsh GPs are not at a disadvantage, and to prevent GPs being dissuaded to work due to high indemnity premiums.
The Bill allows Welsh Ministers to establish a direct indemnity scheme where practitioners will be indemnified directly by the Ministers, in addition to the re-named mutual indemnity schemes (previously called collective schemes) which involves payment being made from a collective joint fund of the health service bodies.
Under the Bill and the amended NHS (Wales) Act 2006, regulations will be made to establish the Existing Liability Scheme which will apply to historic clinical negligence claims which were incurred prior to 1 April 2019.
The Bill and Explanatory Memorandum can be found at: http://senedd.assembly.wales/mgIssueHistoryHome.aspx?IId=26396
Proposed changes to the statutory scheme to control the costs of branded health service medicines
The Department of Health and Social Care published its consultation on 21 January 2020 on the proposed changes to the statutory scheme to control the costs of branded health service medicines to the NHS.
Under the Branded Health Service Medicines (Costs) Regulations 2018 (the Regulations), there is an obligation on the government to conduct an annual review on of the statutory scheme for branded medicine pricing. Medicine providers make payments to the NHS under the scheme of a percentage of their sales in order to control the price the NHS pays for medicines, but without stifling pharmaceutical companies’ research and profitability.
The government intends to reduce the gap in payment percentages between the statutory and voluntary schemes in order to ensure continuity of broad commercial equivalence. Growth in the sale of medicines was lower than expected in 2018-2019, therefore the government believes that the current statutory scheme payment percentages for 2020 and 2021 have been set too high.
The government views that reducing the percentage rates will result in increased revenues for pharmaceutical companies, increased research and development investment into medicines, and helping to ensure the continued availability of medicines to patients by enabling companies to continue to supply the NHS
The amended rates would come into force on 1 April 2020. To compensate for higher rates being in force in the beginning of 2020, the payment percentage for 2020 would be reduced further.
The consultation closes on 17 February 2020.
To view the consultation in full please go to: https://www.gov.uk/government/consultations/branded-medicines-statutory-scheme
CMA welcomes EU Court ruling in pay-for-delay drug case
Generics (UK) v. Competition and Markets Authority C-307/18 – http://curia.europa.eu/juris/document/document.jsf?text=&docid=222887&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=3528524
The European Union Court of Justice (ECJ) handed down a ruling on 30 January 2020, finding that pharmaceutical companies had broken competition law by paying to delay the entry of generic competitors into the market. The Court supported the decision of the Competition and Markets Authority’s (CMA) decision to fine GlaxoSmithKline (GSK) for paying rivals to delay the introduction of generic versions of its drug, paroxetine after its patent had expired.
In making the fine in 2016, the CMA decided that the payment deals had deprived the NHS of significant price reductions. GSK and the connected manufacturers challenged the decision and the Competition Appeal Tribunal sought guidance from the ECJ.
The ECJ held that the appeals tribunal should look at whether customers were deprived of the benefits of the entry into the market of the potential competitors manufacturing their own medicine. In order for such payment deals to be anti-competitive it must be shown that the generic competitors had a real and concrete possibility of access to the market. The ECJ ruled that such delay deals did result in sufficient harm to competition as they could not be viewed other than as a disincentive to new generic entrants to the market.
The ECJ decision clarifies the criteria to be applied by the CMA when handing out fines, and now the judgment will been to be applied by the Competition Appeals Tribunal.
Transition and Handover guidance – Managing the transition from children’s to adults’ healthcare services
The Welsh Government published a Consultation Document on 27 January 2020, seeking responses to the draft Transition and Handover guidance for Health Boards, in relation to healthcare services processes for children as they grow into adults.
Persons aged 16 can give consent to their health care and must be engaged directly in decisions about their health care especially where there is a choice of children or adult services. Children under 16 can give consent to their care if it can be shown that they have sufficient maturity and intelligence to understand the nature and implications of the treatment (Gillick competence). Where a person over 16 seems to be lacking in capacity to make specific decisions, an assessment should be made under the Mental Capacity Act to determine their best interests and the appropriate course of action.
Health Boards will be expected to identify a Transition and Handover lead (such as the Assistant Medical Director, Nurse Director or Director of Therapies) who will have accountability for ensuring the implementation and quality of the transition and handover guidance across all primary, secondary and tertiary healthcare services. They will also have responsibility for liaising with other statutory agencies to ensure that mechanisms are in place for young people and their families with complex needs to have a co-ordinated transition experience.
Health Boards should ensure that feedback is taken from young people so that their views are noted and are at the centre of their care. When implementing the guidance Health Boards and Trusts should use the 5 principles of the children’s rights approach:
- Embedding rights – ensure that policies link with children’s and human rights.
- Equality and discrimination – it should be examined which groups of children may face more barriers to accessing services and measures should be put in to mitigate this.
- Empowerment – children should be informed using accessible methods about their rights concerning the transition and handover of care.
- Participation – children and young people should actively take part in decisions about their own care, and Health Boards and Trusts should involve groups of young people to advise on arrangements to implement this guidance.
- Accountability – Health Boards and Trusts should ensure that there are adequate arrangements for dealing with complaints by young people. The progress in implementing transition and handover arrangements should be made transparent and it should be made clear how young people’s views have been used to develop services.
In every case concerning the transition of handover of a child or young person’s care Heath Boards should apply the following principles:
- Ensure the needs and wishes of the individual are at the heart of service delivery, with safe, responsive care and well-planned handover.
- Promote early and easy access to care and support, particularly for those in crisis, or with disability or disadvantage.
- Work in partnership with statutory services such as social care, education, criminal justice, and voluntary agencies wherever cooperation is required to meet needs.
- Ensure access to information and choices about giving valid consent, and Putting Things Right, including advocacy support if needed to make a complaint or representation. Health boards should ensure that the voice of the young person is heard and at the centre of care.
- Have strong planning, monitoring and governance structures to offer assurance through reporting arrangements, ensuring feedback that captures the voice and views of the individual in a suitable format.
Transition and Handover
When a young person is 13/14 years old the Health Board should identify their healthcare needs and wishes in order to plan the period of transition and handover of care from children to adult services. The decision as to their future healthcare must be made in partnership with the young person and their family.
A Transition and Handover Plan will be co-produced with the young person, their parents/carers and professionals. The Plan will be a ‘passport’ of the young person and include information about what is important to them, the care and treatment required and the timeline and expected health and wellbeing outcomes. The Plan should be accessible and understandable to the young person and it should be linked/ integrated with other care plans if applicable. In preparation for the young person’s 16th birthday a joint review should be undertaken of their Plan to ensure the Plan is person centred, clinically appropriate, realistic, and meets the wishes and best interest of the young person.
The consultation ends 20 April 2020.
To view the full draft Guidance please go to: https://gov.wales/written-statement-launch-consultation-draft-guidance-handover-and-transition-between-childrens-and
NICE’s Draft quality standard calls for use of community pharmacists’ skills
The National Institute for Health and Care Excellence (NICE) has published a draft quality standard consultation, calling for community pharmacy teams to be included in current care and referral pathways.
The draft proposes four quality statements:
- Community pharmacies and local commissioners work together to integrate community pharmacy services into existing care and referral pathways.
- Community pharmacies and local commissioners promote healthcare services and support available from community pharmacies.
- Community pharmacies work with local commissioners to establish population needs, identify gaps in services and agree actions to address health inequalities.
- People who have a long-term health condition or need support to adopt a healthier lifestyle are offered health and wellbeing advice and education when they use community pharmacy services.
The consultation ended on 14 February 2020.
To view the draft quality standard please go to: https://www.nice.org.uk/guidance/indevelopment/gid-qs10115/consultation/html-content
The Health Protection (Coronavirus) Regulations 2020
The Department for Health and Social Care has published The Health Protection (Coronavirus) Regulations 2020 which allow the Secretary of State or a registered public health consultant to impose a requirement on individuals In England that they be detained until the later of 48 hours or until they have been screened for the virus and an assessment carried out.
The requirement can be imposed where the Secretary of State or a registered public health consultant has reasonable grounds to believe that the individual is or may be infected with the virus, they consider there is a risk that the individual may infect others, or the individual has arrived in England from outside the UK and they have reasonable grounds to believe that the individual has been in an infected area in the 14 days prior to his arrival in England.
If an individual is required to be screened they must answer questions on their health and other relevant circumstances, produce any documents which may assist in assessing their health, allow a public health or medical officer to take a biological sample, and provide sufficient information for a public health officer to be able to contact them immediately if the public health officer considers this necessary.
Where a person is to be detained under the Regulations a police constable may enforce the provisions by detaining the individual, using reasonable force if necessary. It is a criminal offence for a person to not comply with the Regulations or to abscond from detention.
The Regulations apply where the Secretary of State declares that the Coronavirus constitutes a serious and imminent threat to public health and that the provisions of the Regulations may reasonable be considered as an effective means of preventing further transmission. The Secretary of State has made such declaration therefore the Regulations will apply from 10 February 2020 for two years until 10 February 2022.
For more information please go to: https://www.gov.uk/government/news/secretary-of-state-makes-new-regulations-on-coronavirus
Consultation on gamete and embryo storage
The government has published a consultation on the storage limits for gametes and embryos. Currently under the Human Fertilisation and Embryology Act 1990 gametes may be frozen for 10 years as a maximum, though in cases of premature infertility the time limit may be longer.
The government sets out the case for extending the legal storage limits due to improvements in freezing technologies, and argument regarding reproductive choice for women. It therefore is seeking public views on potential changes to legislation.
The consultation ends 5 May 2020.
The consultation document can be found at: https://www.gov.uk/government/consultations/egg-sperm-and-embryo-storage-limits/consultation-document-gamete-egg-sperm-and-embryo-storage-limits#responding-to-the-consultation
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