NHS Fife acknowledges and agrees with the importance of regular and timely review of policy/procedure statements and aims to review policies within the timescales set out.
New policies/procedures will be subject to a review date of no more than 1 year from the date of first issue.
Reviewed policies/procedures will have a review date set that is relevant to the content (advised by the author) but will be no longer than 3 years.
If a policy/procedure is past its review date then the content will remain extant until such time as the policy/procedure review is complete and the new version published, or there are national policy or legislative changes.
1.1 NHS Fife has a mandatory duty to audit, protect and exploit Intellectual Property (IP) generated by all NHS employees in the delivery of health care. Innovations attracting IP can include improved interventions and services for health and social care, and new products including those contributing to the education and training of employees.
1.2 The UK Policy Framework for Health and Social Care Research (2017) also places a duty on NHS Fife to have a mechanism in place for the exploitation of Intellectual Property arising from its employees. Innovation in the NHS can be developed during the delivery of any part of the service, as well as from R&D activity..
1.3 This policy sets out a process for the effective identification, protection and exploitation of Intellectual Property within NHS Fife. It is also intended to express the policy as far as possible in non-technical language.
The policy is to encourage and enable staff to participate in the generation of IP as part of its commitment to delivering the best possible patient care. The policy is to maintain a balance between the legitimate needs of NHS Fife to protect its interests, and the provision of a creative working environment for staff. NHS Fife has agreed that revenue generated by successful exploitation of Intellectual Property can be shared with the originators, that is, the members of staff responsible for the innovation. (see also GP/I1-1 Procedure for Management of IP).
2.1 This policy applies across NHS Fife and is applicable to all staff with NHS Fife contracts of employment, wherever employed (see GP/I1-1 Procedure for management of IP). This includes staff whose payroll costs are partially funded by another party (including, but not limited to: a commercial sponsor, government department, or medical charity); unless the contract of employment between the NHS Fife and that party assigns ownership of intellectual property to that party. It also covers trainees and students hosted by NHS Fife for training purposes, members of the public who are representatives on NHS Fife's statutory groups under the Patient Focus Public Involvement Agenda, Non Executive Directors and agency or consultancy staff. Any of these groups may generate Intellectual Property arising from their time spent within NHS Fife.
2.2 Where NHS Fife staff are seconded to another organisation or are working in partnership with other organisations, NHS Fife will agree an arrangement for sharing Intellectual Property and revenue, based on the assumption that all IP generated by NHS Fife employees remains the property of the Board.
2.3 Staff who generate Intellectual Property outside normal working hours and/or away from their place of work where the Intellectual Property relates to their normal course of duties are also included.
2.4 Intellectual Property which has been generated by an employee, in their own time, without NHS Fife resources and which is unconnected with their normal contracted course of duties, will normally be owned by the employee.
3.1 All staff have the responsibility to ensure that they act in accordance with this policy and under no circumstances, will they disclose, sell, assign or trade Intellectual Property without NHS Fife agreement.
3.2 It is the responsibility of all Line Managers to ensure that their staff have read, and comply with, this policy.
3.3 The Assistant Research and Development Director, as the Intellectual Property Lead, has overall responsibility for the management and exploitation of Intellectual Property for NHS Fife. Responsibility includes ensuring that IP awareness training is available to all staff and that identified IP is exploited safely and fully for the good of NHS Fife patients and the organisation.
3.4 The Executive Lead for Research and Development is responsible for overall implementation and review of the Policy.
4 OPERATIONAL SYSTEM
4.1 Intellectual Property is the tangible output (new ideas or concepts) of any intellectual or creative activity that is new or not previously described (see GP/I1-1 Procedure for Management of IP). Once protected, resources can be spent developing results into something useful and investment made in making the results more widely available, with the expectation of recovering that expenditure. However, costs can be considerable so any exploitation should be done in a way which minimises speculative financial investment
from public funds and which does not detract from their primary role in the NHS.
4.2 Any NHS Fife staff can potentially generate new ideas, inventions, innovative solutions or new ways of working during the normal course of their employment. The right of ownership to any Intellectual Property created by an employee during the course of their employment will normally reside with NHS Fife and staff must not under any circumstances sell, assign or trade Intellectual Property without NHS Fife agreement.
4.3 As part of their employment contract or honorary contract, staff will be made aware of the Intellectual Property Policy. NHS Fife will include a statement referring to Intellectual Property within the contract issued to all new staff. For existing staff, the policy will be incorporated into their terms and conditions of employment via the normal national and local collective bargaining arrangements and by the adoption of this policy. A statement will be included in the Licence to Operate agreement for those working on a Licence to Operate basis.
4.4 Employees identifying or creating Intellectual Property thought suitable for protection and / or commercial exploitation whilst acting in the course of their employment, or at any other time using NHS Fife resources, are obliged to inform their Manager and the R&D Office at their earliest opportunity. Ownership of the Intellectual Property and prospects for its commercialisation will then be discussed.
4.5 IP brought to the R&D Department’s attention will be required to be recorded in an Invention Record /disclosure form. Such IP will be assessed by the Assistant R&D Director who will discuss details of the IP with Scottish Health Innovations Ltd (SHIL). If it is decided to explore the potential further, a meeting will be arranged with the R&D Department, the inventor and SHIL to advise whether or not the NHS should exploit the IP, and if so, to discuss the routes for exploitation. Recommended outcomes will be reported to the Executive lead for R&D, for final decision regarding NHS Fife selecting the IP for exploitation. If NHS Fife chooses not to take up its rights to the Intellectual Property, the Intellectual Property rights of ownership (IPR) may be assigned to the employee.
4.6 There are situations where Intellectual Property will arise as a result of interaction with other institutions, including staff joint or Honorary appointments with other institutions. Specific exceptions regarding ownership may also occur where joint work is undertaken with other organisations such as: other NHS bodies; Universities; other academic institutions; and commercial organisations. In such circumstances, Intellectual Property may be owned by an external sponsor or funding body where ownership of any resulting Intellectual Property has specifically defined and agreed in the contract to undertake that work.
4.7 Intellectual Property cannot normally be protected once prior disclosure has occurred, no matter how informal. Where IP has been identified the dissemination through publication of those results must be discussed with the Assistant R&D Director. Confidentiality is generally protected by using written agreements and an NHS Fife Non Disclosure Agreement (see GP/I1-1 Procedure for Management of IP, Appendix 1) can be used to safeguard unprotected Intellectual Property. Agreements are available from the R&D Office which, when completed, will enable staff to then discuss their Intellectual Property with external parties.
4.8 An NHS Fife Invention Record (see GP/I1-1 Procedure for management of IP, Appendix 2), available from the R&D Office, should be used to register any invention/idea. Once completed, this must be submitted to the R&D Office for assessment on how best to proceed to ensure ideas for patenting are processed as quickly as possible. After assessment it may be possible to make public the nature of the idea by publishing an article, giving a talk or poster presentation or disclosing to any outside organisation.
4.9 The R&D Office will maintain a register of all Intellectual Property owned by NHS Fife where a member of the organisation’s staff is a named inventor or originator. A record will be kept of the date on which a member of staff reports to the R&D Office that they are the Inventor/Author of a creative product. Details will also be kept of arrangements entered into by NHS Fife for the protection and subsequent use of the Intellectual Property.
4.10 NHS Fife will negotiate financial arrangements for sharing the proceeds of IP in association with the Framework Agreement in place between NHS Fife and a Technology Transfer Office, Scottish Health Innovations Ltd. (SHIL) which provides the necessary support and advice in managing Intellectual Property for NHSScotland (see GP/I1-1 Procedure for Management of IP).
4.11 Technology Audits (Opportunity Surveys) will be carried out from time to time by the R&D Office in order to identify any potential Intellectual Property arising from staff activities and assess any commercial possibilities. Such audits will involve questionnaires and meetings with staff to discuss the technology transfer process and undertake a preliminary assessment of potential innovations suitable for exploitation. Identification of potential Intellectual Property at an early stage is essential to ensure that correct action is taken to protect any Intellectual Property which might later be developed.
5 RISK MANAGEMENT
5.1 The adoption and implementation of this policy will ensure a robust, fair and transparent process which will significantly reduce risks due to the unregulated development of Intellectual Property within NHS Fife.
5.2 The risk around unwise investment by NHS Fife resulting from the implementation of this policy is mitigated by an ongoing process of consultation and collaboration with Scottish Health Innovations Ltd (SHIL) in all IP development and selection. SHIL is recognised throughout the NHS as an organisation trained in IP protection and development and has a Service Level Agreement with NHS Fife.
5.3 This policy will be regularly reviewed as part of the implementation process.
6. RELATED DOCUMENTS
Handling Inventions and Other Intellectual Property. A Guide for NHS Researchers. NHS Executive. 1998
The Management of Intellectual Property and Related Matters. An Introductory Handbook for R&D Managers and Advisers in NHS Trusts and Independent providers of NHS Services. NHS Executive. 1998
Policy Framework for the Management of Intellectual Property within the NHS Arising from Research & Development. NHS MEL (1998) 23
Patent Protection. The Patent Office. 1998
The Patents Act. 1977
The Copyright, Designs and Patents Act. 1988
Baker Report. ‘Creating Knowledge Creating Wealth’ - Realising the Economic Potential of Public Sector Research Establishments. 1999
Policy Framework for Health and Social Care Research. 2017.
Guidance for NHS Scotland is set out in "A Framework and Guidance on the Management of Intellectual Property in the NHSScotland" (HDL(2004)9).