The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance to provide clarity on the disclosure obligations and commercial governance expected from companies in relation to package deals (Guidance). The Guidance responds to analysis conducted by PMCPA in 2025 which revealed “varying longstanding practices in relation to package deals among companies, particularly in relation to disclosure of transfers of value”.
What is a package deal?
PMCPA notes that there are many different types of package deal and therefore it is difficult to give universal guidance. Companies must be confident that the arrangements they have in place meet the requirements of the ABPI Code (Code) and that they can explain the rationale for their decisions and actions.
Package deals are defined by reference to the supplementary information to Clause 19.1 of the Code, namely “commercial arrangements whereby the purchase of a particular medicine is linked to the provision of certain associated benefits as part of the purchase price..”. The guidance clarifies the scope of the arrangements captured and provides examples of services or items that would constitute an “associated benefit”.
Examples of what may be considered an “associated benefit” include:
- Apparatus for administration of the medicine
- Home delivery or homecare services
- Medicine-related support service, e.g. genetic or biomarker testing linked to the prescription of a medicine
- Patient education or patient support services
- Digital tools such as remote monitoring platforms
Associated benefits in this context do not include terms of trade such as financial discounts and free of charge company goods (e.g. 10 for the price of 9) and materials provided directly to healthcare professionals or patients.
Any package deal must also be fair, reasonable and the associated benefit related to the medicine.
Disclosure obligations
In accordance with Clause 28 of the Code, any transfers of value to healthcare organisations (HCO) made in relation to a package deal must be disclosed via Disclosure UK. This is subject to two exemptions: package deals solely relating to ordinary course purchases and low value items for patient support that directly benefit patient care (Clause 1.25).
Ordinary Course Purchases
The Guidance establishes a decision-making framework for distinguishing “ordinary course purchases” from reportable transfers of value. For a package deal to be classified as an “ordinary course purchase”, the associated service or item must be specific to the medicine, essential for its appropriate use, and detailed as such in the product’s Summary of Product Characteristics (SmPC).
The Guidance gives the following example of a package deal that could be considered an ordinary course purchase: The use of a medicine requires a specific genetic test prior to prescription. The company offers to provide the genetic test as part of the purchase price of the medicine and pays a third party HCO to conduct the test. In this example, the genetic test is “specific to and essential for” the appropriate use of the medicine and therefore the value of the genetic testing does not need to be disclosed against the HCO taking up the package deal. However, the fee paid to the third party should be disclosed as a fee for a service.
The following would not be considered ordinary course purchases:
- The use of a medicine requires monthly liver function tests (LFTs). The company offers to provide a monthly blood testing service as part of the purchase price of the medicine. While the requirement for LFTs is detailed in the SmPC and is essential for the appropriate use of the medicine, such clinical monitoring is not specific to the use of that particular medicine.
- The company offers to provide a homecare service as part of the purchase price of the medicine. Homecare is not detailed in the medicines SmPC and is not essential for the appropriate use of the medicine.
In both instances, the value of the service provided should be disclosed against those HCOs taking up the package deal.
When disclosure is required, the Guidance states that it is preferable for companies to disclose the value to the recipient HCO that ultimately benefits from the service (e.g., an NHS Trust), rather than the fee paid to the third-party provider. This is because the relationship between the company and the beneficiary HCO to be of greater public interest. Companies should avoid double disclosure and should describe the approach taken in its methodological note.
Items for Patient Support
Items for patient support referred to in Clauses 19.2 and 26.3 may be supplied to an HCO as part of a package deal or provided directly to healthcare professionals or patients outside of a package deal. Either way, they are exempt from disclosure.
Such items must be inexpensive (having cost the company less than £15 excluding VAT and with a similar perceived value to the recipient) and directly benefit patient care.
As a general rule, companies cannot use a package deal to circumvent the financial limit for patient support items. However, the Guidance clarifies that companies could justify providing support items of more than £15 excluding VAT if the item has no retail value and is required for safe supply of the medicine. For example, provision of a demonstration auto-injector for the patient to practice the technique at home.
Enforcement of disclosure obligations
As the disclosure of transfers of value is a Code requirement (and not a legal one), PMCPA has stated that complaints on this topic will not be adjudicated until the end of June 2027. This window is designed to allow companies to correct past disclosures and align future reporting with the new Guidance.
Companies are therefore recommended to:
- Conduct a portfolio review to assess all active package deals against the latest guidance to reclassify arrangements as either ordinary course purchases or reportable transfers of value.
- Utilise the non-adjudication period to conduct a gap analysis of past disclosures and correct data on Disclosure UK by the end of June 2027.
- Ensure planned package deals are aligned with the new standards.
Governance
Regarding the governance of package deals, the PMCPA advises companies take the following steps:
- Create clear policies for the approval and oversight of package deals.
- Establish a cross-functional group (comprising medical, legal, and pharmacovigilance personnel) to oversee package deals from concept to termination.
- Consider when certification of materials is required. Package deals are a commercial arrangement and therefore generally considered promotional.
- Materials communicating the package deal to health professionals and other relevant decision makers will likely be promotional and require certification under Clause 8.1 and should contain prescribing information, a statement on adverse event reporting and other obligatory information required by Clause 12.
- Materials/items intended for patients must be non-promotional and certified under Clause 8.3.
- Ensure all third‑party providers involved in delivering services within a package deal are adequately trained. Be sure to document training and have ongoing oversight of the conduct of the service provider.
- Make it clear on all materials related to a package deal, including those for patients, that the associated benefit is funded by the company.
- Enter into written agreements with clear roles and responsibilities, pharmacovigilance obligations and exit plans to ensure patient care is not compromised upon the termination of the commercial arrangement.
Companies should also ensure compliance with other aspects of the Code in relation to package deals, for example the promotion of the medicine in accordance with the SmPC and the prohibition on inducements.
Conclusion
The PMCPA’s new Guidance represents a substantive clarification of expectations under the Code, particularly in relation to governance and transparency. With the PMCPA signalling that aspects of this Guidance may be incorporated into the next Code update, and with the introduction of a defined amnesty period, now is the time for companies to map, review, and update their package deal frameworks.
Companies should also look out for a training webinar about the Guidance in February 2026, where the PMCPA will be answering questions from stakeholders.