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New agreement launched to streamline research collaboration between life sciences industry, universities and the NHS

23rd February 2011

Research into new and improved treatment for patients received a major boost today when the Government announced the launch of a new model agreement between the pharmaceutical and biomedical industries, universities and the NHS to streamline the research contracting process.

Use of the model Industry Collaborative Research Agreement – mICRA – will enable research studies involving industry, universities and the NHS to start faster by shortening the negotiation and contracting process. The agreement is part of the Government’s aim to promote the development of new and improved treatments for patients by reducing bureaucracy and supporting a flourishing research environment.

The National Institute for Health Research through its Office for Clinical Research Infrastructure (NOCRI) and the Medical Research Council have led a working group to develop the agreement. They brought together representatives from industry, universities and the NHS, together with the Intellectual Property Office and expert legal opinion to develop a range of templates that can be used to support all collaborative research scenarios.

The model agreement has been drafted to allow it to be used as a template for contracts covering any or all stages of clinical research undertaken collaboratively, from early proposals for collaboration and throughout.

Health Minister Lord Howe said:

“Partnerships between industry, NHS and universities are becoming one of the most important routes for the development of new and improved treatments for the benefit of patients. The expert clinical researchers and research infrastructure we fund through the NIHR are world-class resources and the launch of mICRA should remove some of the barriers so they can start their research quicker and help to deliver better treatments to more patients, faster.’

A key element of collaborative relationships between industry, the NHS and universities is the ownership of intellectual property (IP). Ensuring the adoption of appropriate terms can lead to extended negotiations and delays to early phase research getting underway. The model agreement has a choice of five options for clauses covering IP arrangements ranging from full academic ownership with rights granted to a company, through to full company ownership of IP with rights granted for teaching, research and patient care. The choice of IP clauses is supported by a decision tree with structured questions to guide users through the process.

Baroness Wilcox, Parliamentary Under Secretary for Business, Innovation and Skills, highlighted the importance of the new model agreement:

“Public/private sector collaboration is vital for innovation and growth. The mICRA agreement represents an important new venture in health research, a leading sector for the UK economy.

“I very much welcome this new agreement, which will smooth the negotiation process in collaborative working. It will build on the success of the Lambert agreements in bringing clarity about ownership and access to IP, as well as ensuring IP continues to enable innovation.”

The pharmaceutical and biotechnology industries have been essential partners in developing a model agreement that is fit for purpose and can be endorsed by all sectors.

Dr Allison Jeynes-Ellis, Medical – Innovation Director at the Association of the British Pharmaceutical Industry, said:

“The research and development model for the pharmaceutical industry is changing, with potential new therapeutic approaches being developed in close partnership with experts in our leading academic research centres. The contracting process has often been a barrier to companies working with UK academia. The development of a standard agreement should greatly speed up this process and provide a firm foundation for fruitful collaborations. The ABPI looks forward to widespread use of mICRA resulting in a reduction in bureaucracy and more rapid research start up times.’

Dr Mary Archer, convenor of the Chairs’ Group of the Association of UK University Hospitals and AUKUH member of the working party, welcomed the launch of mICRA:

“Universities and NHS organisations often do not have the legal resources needed to enter confidently into collaborative arrangements with industry. This model contract and guidance will provide a firm foundation for the establishment of these types of partnerships on a consistent basis across the UK. A standardised and transparent approach ensuring an appropriate division of risk and reward will mean that our institutions can establish partnerships with industry more rapidly and with greater confidence.”

The template model contract, supporting decision tree and full guidance information can be downloaded from the NOCRI pages of the NIHR website at: www.nihr.ac.uk/nocri

 

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