Regulatory Timeline: Life Sciences and Healthcare
Published on 7th Oct 2015
“The topics that will continue to dominate headlines: greater integration between emergency services; 7-day NHS services; NHS estates strategies; and caps on agency staff. As ever, there is a balancing act with these between driving efficiency and cost savings against improved patient care, as part of the NHS Five Year Forward View.
In social care, the postponement of the cap on the cost of care is significant. It gives local authorities, together with the third and private sectors, breathing space to be properly prepared for the new system and how individuals can be best supported with the costs of care.
The key development on the horizon for life sciences is the introduction of new regulations governing medical devices. The timetable for adoption of the new regulations has slipped and now looks likely to be during 2016.”
1 October 2015 – Prototype model for dental practices
A new ‘prototype’ model for dental practices is being rolled out this autumn, building on a recent pilot looking at possible reform in this area. The changes under the prototype model will see the introduction of clinical pathways, clinical measures and revised remuneration, including “at risk” elements to payments for under-delivery. The prototype phase is expected to be followed by full reforms in the way that dental practices operate and are remunerated.
1 October 2015 – Transfer of public health responsibilities for 0-5 years
On 1 October 2015, responsibility for planning and paying for public health services for 0-to-5-year-olds, including health visiting, transfers from NHS England to local authorities. The transfer is part of a wider transfer of public health functions from NHS to local government under the Health and Social Care Act 2012. The transfer will not, however, involve a transfer of employment for health visitors or family nurses, who will remain employed by provider organisations. The NHS will also retain some limited commissioning functions.
17 December 2015 – National Data Guardian for Health and Care
On 17 December 2015, consultation closes on the responsibilities of the statutory National Data Guardian for health and social care for the use and safeguarding of personal confidential data held and used to support better outcomes from health and care services.
31 December 2015 – Proposed Medical Devices Regulation
The new Regulation on Medical Devices stalled in negotiations over concerns around: implants for aesthetic purposes, ingested products, reprocessing of single-use devices and the unique device identification system. A revised, consolidated text of the Recitals and Articles has been published in the Council Register. The first reading by the Council is awaited, with adoption currently planned for December 2015. However, we expect that this timetable may slip, with the new Regulations to be adopted in 2016.
3 February 2016 – Consultation on GCP guidelines
The European Medicines Agency is consulting on updated guidelines on Good Clinical Practice for conducting clinical trials, which have not been updated since 1996. Changes are proposed in particular to the standards regarding electronic records and certain essential documents, which are intended to increase the quality and efficacy of clinical trials. The consultation closes on 3 February 2016.
April 2016 – Care Support Means Testing
The upper and lower capital limits for means tested support will be increased with the intention that more people will become eligible for local authority financial support. The uppers limits will be £118,000, including the value of their property when in a care home, and £27,000 in other circumstances.
18 April 2016 – End of transitional arrangements for NHS procurements
Procurements for contracts for certain NHS healthcare services will remain on the old 2006 procurement regime until 18 April 2016. For more details on the changes, please see our Regulated Procurement section.
2016 – Custodial health services
Legal responsibility for commissioning of custodial health services is expected to transfer to NHS England during 2016.
April 2020 – Cap on costs of care
The provisions under the Care Act 2014 limiting the amount people have to pay towards their eligible care and support have been deferred from April 2016 to 2020. This is in part to give the private insurance market time to respond.
