A Common Understanding 2025

8.Legal Considerations

Data Protection

All parties to a collaborative working arrangement will need to comply with Data Protection legislation. This includes, but is not limited to, the UK General Data Protection Regulation (UKGDPR) and 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 representatives may be given access to data and/or records that could identify or be linked to particular patients.

Given that collaborative working will involve NHS patients, it would be preferable to make clear in the 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

Care must be taken if an individual healthcare professional or NHS employee could benefit personally from any collaborative 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 a collaborative working project, 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 collaborative project. NHS staff are encouraged to review relevant local policies.

The ABPI Code states that collaborative working must not constitute an inducement to health professionals or other relevant decision makers to prescribe, supply, recommend, buy or sell any medicine. It must, therefore, always be ensured that none of the benefits of any collaborative working project go to these individuals or their practices. If there are benefits which are due to the NHS, these must go to an NHS or similar organisation.

Competition and Commercial in Confidence Issues

Collaborative 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 collaborative 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 discuss or disclose confidential or commercially sensitive 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 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.