Regulatory Timeline: Life Sciences and Healthcare

“In the Healthcare sector the implementation of the Care Act marks the start of a significant shake-up of social care provision in England. In particular, local authorities can soon allow the elderly to use the value of their homes to help pay care home costs (repayable on the sale of their home). There is still over a year until the cap on the cost of care is introduced.” – Associate Director Simon Hancock

“The most important forthcoming changes in the Life Sciences sector are ones we cannot yet see in detail: the inclusion in the Transatlantic Trade and Investment Partnership, still under negotiation with the USA, of provisions on mutual recognition of Good Manufacturing Practice inspections; the exchange of confidential information between the EMA and FDA; harmonisation on marketing authorisation of biosimilar products; and streamlining the authorisation of generics. If these EU proposals are incorporated in the final texts, it could mean substantial changes for pharma regulatory affairs over the next three years.” – Partner Lorna Brazell

8 March 2015 – Consultation closes on NHS Bodies and Local Authorities Partnership Arrangements

The Department of Health has issued a consultation on proposed Regulations that would make it possible for pooled budgets to include funding for primary medical care. The aim is to encourage greater integration across community health, social care and primary care.

31 March 2015 – Language ability checks for EU trained healthcare workers

Anticipated date for an amendment Order that will allow regulators in the healthcare sector to seek evidence of English language competence from EU trained healthcare workers who are looking to work as healthcare professionals in the UK and who apply for registration with them. The regulators will need to amend their rules, following the Order coming into force, to implement the changes.

1 April 2015 – Independent healthcare regime

Anticipated date for roll-out of new regulatory regime for independent healthcare providers (to be implemented by CQC).

1 April 2015 – Implementation of part of Care Act 2014

Changes introduced by the Care Act 2014 include:

• a new national level of care and support needs to make care and support more consistent across the country;
• new support for carers; and
• deferred payment agreements for care costs.

30 June 2015 – Biosimilars

The three Guidelines on similar biological medicinal products containing Recombinant Human Insulin, low-molecular-weight heparins and recombinant interferon alpha are currently under revision. Final revised versions are due to be released later this year.

1 July 2015 – Independent healthcare ratings published

Anticipated date for roll-out of CQC evaluated ratings for independent healthcare providers, following implementation of new regulatory regime.

1 October 2015 – Dentistry prototypes

Roll-out of prototypes, building on the recent pilot, before full reforms are implemented. The changes see the introduction of clinical pathways, clinical measures and revised remuneration, including “at risk” elements to payments for under-delivery.

1 October 2015 – Transfer of public health responsibilities for 0-5 years

Planning and paying for public health services for 0-to-5-year-olds, including health visiting, transfers from NHS England to local authorities. Limited commissioning responsibilities will remain with the NHS.

31 December 2015 – Proposed Medical Devices Regulation

The new Regulation on Medical Devices stalled in negotiations at the end of 2014 over concerns around: implants for aesthetic purposes, ingested products, reprocessing of single-use devices and the unique device identification system. A new text is expected to be prepared taking these concerns into account with a view to adoption of the Regulation in 2015.