On 1 April 2013 the National Institute for Biological Standards and Control (NIBSC), currently part of the Health Protection Agency (HPA), will officially become a new ‘centre’ of the Medicines and Healthcare products Regulatory Agency (MHRA) alongside the Clinical Practice Research Datalink (CPRD).

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MHRA and NIBSC already work closely together and have common interests in managing risks associated with biological medicines, facilitating development of new medicines safely and effectively, and maintaining UK expertise and ability to contribute to assuring the quality and safety of medicines in Europe and beyond.

 

The developments will create a new organisation that is a world leader in supporting science and research and the regulation of medicines and medical devices, and will strengthen the support provided to the UK’s medicine’s industry.

 

It’s business as usual whilst we evolve! All your usual contacts remain the same.

 

See our questions and answers section below for more on the developments and if you have any further

questions or comments on the merger you can contact us on info@mhra.gsi.gov.uk or 0203 080 6000.

 

Timeline for development

 

Questions and Answers

 

What is the rationale for moving NIBSC from the HPA to MHRA?

• The Health Protection Agency's (HPA) National Institute for Biological Standards and Control (NIBSC) carries out various statutory functions relating to biological standardisation and control of medicines.
• These were formerly the responsibility of the National Biological Standards Board, but were transferred to the HPA when NIBSC merged with it in April 2009.
• The Health and Social Care Bill transfers all HPA functions to the Secretary of State, specifically including the functions associated with NIBSC.
• At the Department of Health’s request the Agency Board of the Medicines and Healthcare products Regulatory Agency took the opportunity to reconsider the best organisational model for NIBSC and, following a due diligence process, concluded that the best fit in the future was with the MHRA.
• The two organisations already work closely together and have common interests in managing risks associated with biological medicines, facilitating development of new ones safely and effectively, and maintaining UK expertise and influence in Europe.

 

Why is NIBSC moving to MHRA rather than being part of Public Health England like the rest of the HPA?

• Public Health England will have key functions to deliver services to protect public health; provide information and intelligence to support local public health services and support the public in becoming healthier.
• Both the MHRA Board and the HPA Board have agreed that NIBSC would better sit with MHRA as their functions provided a much closer fit compared to those functions moving to Public Health England.

 

Why not create NIBSC as a stand-alone Agency as it was previously?

• The Department of Health’s Arms' Length Bodies’ (ALB) review, published by Health Secretary Andrew Lansley in July 2010, set out plans for a more streamlined ALB sector where synergies between ALBs are exploited and efficiencies increased. As such there was no option for NIBSC to return to a stand-alone arms' length body.
• The transfer will enable both organisations to take advantage of the synergies that exist between the work of NIBSC and the MHRA.

 

What benefits will the merger bring?

• The two organisations already work closely together and have common interests in managing risks associated with biological medicines, facilitating development of new ones safely and effectively, and maintaining UK expertise and influence in Europe.
• The merger will strengthen the UK’s ability to compete internationally and better manage the risks and opportunities associated with future development.

 

Who made the decision?

• Following the decision from the MHRA Agency Board that they agreed to the proposal for NIBSC to join the organisation, a recommendation was made to the Secretary of State for Health, Andrew Lansley CBE MP, who made the final decision.

 

Are you planning to formally consult on these changes?

• The changes are as a result of a ministerial decision. Where there are any changes for staff or customers we will of course consult with the relevant groups.

 

What are the cost implications of the merger for the tax payer?

• It is anticipated that the merger will be cost-neutral and forms part of the overall DH transition programme.

 

When will the merger take place?

• The MHRA's Agency Board has recommended that the transfer of NIBSC from the Health Protection Agency to the MHRA takes place on 1 April 2013.
• MHRA and NIBSC are already working together to establish systems and management arrangements for the transfer without any destabilisation of functions or services. Implementation of the transition will take place throughout 2012/13 as appropriate to business requirements.
• This aligns with the timetable for the other health reforms.

 

Will a new organisation be formed?

• There will be a significant expansion of the Agency’s responsibilities, with the establishment of two new Centres: the Clinical Practice Research Datalink (CPRD), headed by John Parkinson, on 1 April 2012, and the National Institute for Biological Standards & Control (NIBSC), headed by Stephen Inglis, on 1 April 2013. The Regulatory Centre, NIBSC Centre and CPRD Centre constitute the three operational ‘pillars’ of the Agency – together with the Corporate Divisions already in existence in MHRA.

 

Who will be the head of the organisation and what will the executive board structure look like?

• As Chief Executive, Kent Woods, will chair the ‘Corporate Executive Team’ (CET) which is the highest executive decision-making body of the Agency. It comprises the directors of each of the Agency’s divisions, the directors of the NIBSC and CPRD centres, and a representative from DH Legal Services.
• There will continue to be a Chairman and an Agency Board with Non Executive Directors, which is responsible for monitoring the implementation of Ministers’ objectives for the strategic direction of the Agency.

 

What will happen to the NIBSC brand that is world renowned and respected?

• It is well recognised that NIBSC has a world class reputation for its work, particularly its role as the leading global developer and supplier of international standards for biologics.
• Previous strategic reviews have strongly recommended that the NIBSC brand should be protected and every effort will be made to ensure that this is achieved. Government’s Digital Leaders Network, for example, has recommended that the NIBSC website continue to be run independently of the of the new single Government domain Gov.uk.

 

Will the work that NIBSC and MHRA currently undertake change?

• The transfer will look to take advantage of the synergies that exist between the work of NIBSC and the MHRA and maximise the benefits of the merger, but the core work of the organisations won’t change.

 

How will NIBSC’s customers be affected?

• NIBSC core business remains unchanged and customers will be largely unaffected. Customers will be kept informed of progress relating to the merger as appropriate.

 

The MHRA currently regulates functions carried out by NIBSC, how will this work in future?

• The MHRA, NIBSC and the HPA are working together to ensure that any potential conflicts of interest that might arise are properly handled.

 

How is the MHRA’s Trading Fund status affected by the merger?

• The MHRA remains a Trading Fund. NIBSC assets, liabilities, costs and revenues will be incorporated into the Fund from 2013, by virtue of an additional order.

 

How will you communicate about the merger to external stakeholders?

• The MHRA and NIBSC are planning a range of communication activities to ensure that external stakeholders are kept informed throughout the merger.

 

Will any jobs be lost as a result of the transfer?

• No