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Supporting healthcare professional interactions

Life Science Law > Supporting healthcare professional interactions

Structures and documentation to govern external engagements.

Business relationships with healthcare professionals and organisations are tightly governed by complex laws and regulations that require proper structure and documentation to ensure compliance and avoid inadvertently tripping up.

LS Law offers full service legal and compliance support to help businesses devise and execute strategies that allow them to remain compliant and avoid unintended breaches of the law when working with prescription-only products.

Typical scenarios where a pharmaceutical company might need specialist legal support:

Package Deals

Devising a package deal for a pharmaceutical product that includes a free pre-diagnosis testing service. Legal consideration of Competition Laws and the Medicines Acts surrounding pricing to ensure the offer can’t be deemed an inducement to prescribe, anti-competitive, or in breach of Industry Regulations, including the ABPI Code of Practice.

Advisory Board

Legal input on structuring advisory boards with healthcare professionals, ahead of them being created. This process will ensure the format is aligned with regulatory requirements around the exchange of scientific data for a therapy that’s still pre-marketing authorisation or for an off-label indication.

Patient Support Programme

Legal advice to support the development of patient support programmes – such as a home care service for administration of prescribed products or educational support surrounding prescribed products to patients. Guidance will be required that account for the legislation around inducement-to-prescribe, the risk of liability of out-sourced nursing services and industry codes of practice when creating a package of support services. Consideration must also be given to possible promotion and the structure of the service to ensure compliance.

Sponsorships, Grants and donations

An agreement will need to cover the provision of financial support to healthcare professionals and organisations. Responding to unsolicited requests for financial support or assistance with activities that have a medical or educational element require careful structuring to ensure compliance and that a written agreement is correctly documented.

Named Patient Supply

Off-label supply must be unsolicited and documented in a written agreement. An agreement with a healthcare organisation or professional will be fundamental in response to any unsolicited request for the supply of a medicinal product off-label or pre-marketing authorisation.