The Association of Medical Research Charities (AMRC) states in its publication An Essential Partnership: A guide for charities working with industry
All parties to a Joint Working arrangement will need to comply with Data Protection legislation including, but not limited to, the General Data Protection Regulation (EU) 2016/679 (“GDPR”) and any national implementing laws, regulation(s) and secondary legislation as may transpose the GDPR into the domestic law of all or any part of the United Kingdom (including, without limitation, the Data Protection Act 2018), in each case as such law(s) may be replaced, supplemented, substituted or amended from time to time.
Under the ABPI Code, neither a pharmaceutical company nor its medical/generic representatives may be given access to data/records that could identify or could be linked to particular patients.
This does not preclude individual employees from accessing patient-identifiable information provided they are an appropriately qualified person (e.g.
a healthcare professional, statistician) and not employed in a promotional role.
Given that Joint Working will involve NHS patients, it would be preferable to make clear in the Joint Working agreement (and/or secondment/NHS honorary contract) that the NHS organisation is the “data controller”, i.e. the person or entity that determines the purpose and the means of any data processing. The data controller is ultimately responsible for ensuring that patient confidentiality and/or privacy are adequately protected.
Anti-Bribery and Corruption:
Particular care must be taken if an individual physician or NHS employee could benefit personally from any Joint Working arrangements.
This is because UK corruption laws (including, but not limited to, the Bribery Act 2010) and comparable legislation in the United States (the Foreign Corrupt Practices Act), prohibit the offering, promising or giving of a financial or other advantage to public officials for the purpose of obtaining any improper business advantage.
Although the NHS as an organisation may benefit from Joint Working projects, this is unlikely to breach Anti-Bribery and Anti-Corruption laws unless one or more public body officials (e.g. an individual NHS healthcare professional or NHS employee) is offered, promised or given a direct or indirect personal benefit from a particular Joint Working project. That is why it is preferable to agree primary care Joint Working projects at Clinical Commissioning Group (CCG)/Health Board level or above.
Competition and Commercial in Confidence Issues:
Joint Working projects may involve more than one pharmaceutical company, so Competition and Commercial in Confidence issues may arise. Anticompetitive agreements, decisions or concerted
practices between companies (e.g. agreeing prices or discount schemes with competitors) are illegal. Each company should seek its own advice to ensure that it complies with competition law in force at the relevant time and enters into appropriate confidentiality agreements and other safeguards to keep its commercially sensitive information confidential. Where competing companies need to discuss setting up a Joint Working project, they should consider taking the following steps:
- Establish a written understanding of the purpose and scope of the discussions to ensure that they remain consistent with the parties’ objectives and do not stray into areas that could raise competition law issues (e.g. pricing, market practices)
- Create a written agenda for meetings which can be approved in advance
- Limit participation to appropriate personnel who are briefed about the potential competition concerns and the importance of keeping to the approved agenda
- Consider whether legal counsel from at least one of the companies should be present at the meetings
- Take detailed minutes of all meetings which are then reviewed by legal counsel and retained
- Do not disclose or discuss confidential or commercially sensitive information. In particular do not discuss or disclose confidential information or enter into agreements in the following areas:
- The pricing of products or commercial strategies of any of the companies
- Individual company cost components or structures, or the relationship between cost and price in the industry generally
- Allocation of markets or market practices, either in relation to particular customers or geographical regions
- Actual or potential company-specific customer relationships
- Actual or potential bidding opportunities, and each other’s responses to such opportunities - Individual company or industry production levels, capacities, or inventories, or individual company market shares, or research and development activities or results
Related content in this section:
- Joint Working - a toolkit for industry and the NHS
- Routes to Cross-Sector Working
- Joint Working: A ten-step process
- Legal considerations: regarding Joint Working
- Appendix 1: Joint Working Case Studies
- Appendix 2: Clinical trials collaboration
- Appendix 3: Medical and Educational Goods and Services (MEGS)
- Appendix 4: Cross-sector working at ICS/STP level
- Appendix 5: Working with patient organisations