Regulatory Timeline | Life Sciences and Healthcare – April 2016

Written on 14 Apr 2016

“The implementation plan for the Prime Minister’s Challenge on Dementia 2020 brings the public and private sectors together, across the health and social care and wider Life Sciences communities, in setting measurable goals. The ultimate aim is to pave the way for England to become the best country in the world for dementia care, support, research and awareness.”

Simon Hancock, Partner, Osborne Clarke

“Life sciences regulation continues to evolve to meet the challenges of new technologies. The new Medical Devices Regulation will bring greater transparency and scrutiny to the medical devices sector. For digital health businesses in particular, the upcoming overhaul of EU data protection law will ensure that the use of personal data continues to present significant regulatory challenges.”

Lorna Brazell, Partner, Osborne Clarke

April 2016 – Care support means testing

The upper and lower capital limits for means-tested support had been expected to be increased for the financial year 2016/17, with the intention that more people would become eligible for local authority financial support. However, it has recently been announced that the relevant upper limit and lower limits will remain the same as for the financial year 2015/16.

1 April 2016 – Personalised medicine

New scientific guidelines on pharmacogenomics came into effect on 1 April 2016. The guidelines cover:

  • how to evaluate pharmacovigilance-related issues for medicinal products with pharmacogenomic associations; and 
  • how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

The guidelines also highlight aspects of pharmacovigilance activities and risk minimisation measures for the use of medicinal products in genetic subpopulations.

1 April 2016 – Care Quality Commission (CQC) fees

The Care Quality Commission (Fees) (Reviews and Performance Assessments) Regulations 2016 came into force on 1 April 2016.

The Regulations give the CQC a power to charge fees for performance assessments and reviews carried out under section 46 of the Health and Social Care Act 2008.

15 April 2016 – Good Manufacturing Practice Guidelines for products for export of human investigational products

Updated EU Good Manufacturing Practice Guidelines regarding medicinal products or investigational medical products for human use came into effect on 15 April 2016.

The guidelines relate to the certification by a qualified person on batch-release within the EU, or made for export, of medicinal products for human or veterinary use, or investigational medicinal products for human use.

The revision follows on from the Falsified Medicines Directive (2011/62/EU) and implements ICH quality guidelines Q8-Q10.

18 April 2016 – End of transitional arrangements for NHS procurements

On 18 April 2016 the transitional arrangements under the Public Contracts Regulations 2015 (PCR 2015) came to an end. Procurement exercises for NHS contracts commencing after that date will be governed by the new regime, under the PCR 2015, rather than the old regime under the Public Contracts Regulations 2006.

For more details on the changes, please see here.

2016 – Custodial health services

Legal responsibility for commissioning of custodial health services in England is expected to transfer to NHS England during 2016.

2016 – Medical Devices Regulation

The new draft Medical Devices Regulation did not receive approval from the European Council in December 2015, but is expected to pass in the course of 2016 and is unlikely to come into effect before 2019. The Regulation will represent a major overhaul of the regulatory regime for medical devices.

2016 – General Data Protection Regulation (GDPR)

With data of central importance across the life sciences and healthcare sectors, all organisations should be aware of the incoming GDPR.

The GDPR, which represents the biggest change to the law on data protection for 20 years, is expected to be passed in 2016 and come into effect in 2018.

For more information, see here.

Q4 2016 – Dementia: deprivation of liberty safeguards

The Law Commission is due to provide its full proposals by the end of 2016 on whether the current safeguards relating to the Mental Capacity Act 2005 are sufficient. The underlying issue is that where an individual lacks the mental capacity to consent to accommodation, this could amount to a “deprivation of liberty”.

9 February 2019 – Falsified medicines

From 9 February 2019, most medicines, including some non-prescription medicines for human use will need to include a unique identifier (a 2-dimension barcode) and an anti-tampering device on the packaging.

2020 – Dementia Research Institute

Under the government’s “Challenge on Dementia 2020: Implementation Plan”, the national Dementia Research Institute is set to be fully operational by 2020.

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.

For more information and details of all of the other areas covered by the Regulatory Timeline click here or download the full Timeline here.

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