On 19 January 2026, The Prescription Medicines Code of Practice Authority (PMCPA) guidance on package deals was published.
There are many different types of package deals and therefore it is difficult for the PMCPA
to give universal guidance in this area.
Companies must be confident that the arrangements they have in place meet the requirements of the ABPI Code and that, if a complaint were received, they would be able to explain the rationale for their actions and decisions.
You can read more about the ABPI Code of Practice in this blog post. You can also refer the 2024 Interactive ABPI Code of Practice here where you can access all of the clauses of the code under ABPI principles 1 – 6.
What is the definition of a package deal?
The supplementary information to Clause 19.1 defines package deals as commercial
arrangements whereby the purchase of a particular medicine is linked to the provision of
certain associated benefits as part of the purchase price, such as apparatus for
administration of the medicine, the provision of training on its use or the services of a
health professional to administer it.
- Transfers of value made in the course of these package deals would need to be disclosed in accordance with Clause 28.
- The transaction as a whole must be fair and reasonable and the associated benefits must be relevant to the medicine involved.
- Clause 1.25 exempts package deals solely relating to ordinary course purchases and sales of medicines from the requirement to disclose transfers of value.
- Companies can provide genetic testing or other biomarkers/specific testing in relation to the rational use of its medicines.
- Where the use of a medicine requires specific testing prior to prescription, companies can arrange to provide such testing as a package deal even when the outcome of the testing does not support the use of the medicine in some of those tested.
What a company provided ‘associated benefit’ does not include
Package deals are arrangements with a healthcare organisation (HCO) where the
company provides an associated benefit, such as a service or item, as part of the
purchase price of its medicine. An ‘associated benefit’ in this context does not include:
- Financial discounts considered as terms of trade referred to in the supplementary
information to Clause 19.1. These are ordinary course purchases and sales of
medicines and exempt from disclosure of transfers of value. - Free of charge company goods – A commercial arrangement including some free
goods (such as ‘10 for the price of 9’) might be considered a term of trade. These
are exempt from disclosure of transfers of value. The provision of unlimited or
excessive free goods would not be acceptable under the Code. - Materials – While materials for health professionals and patients may be provided to
an HCO in association with a package deal, they may also be provided directly to
health professionals/patients outside of a package deal. There are no transfers of
value to disclose in relation to materials
By their very nature, package deals are inextricably linked with a specific medicine and
cannot be considered a donation under Clause 23.
What are examples of package deals
Examples of package deals include (non-exhaustive):
- Home delivery and/or administration services (including homecare) – For example,
where a pharmaceutical company provides the services of a health professional
(e.g. a nurse), either directly employed by the company or via a third-party agency,
to administer the company medicine to patients to whom it has been prescribed.
Such health professionals do not have the authority to prescribe the medicine or
amend the prescription. They will administer the medicine to the patient as
prescribed. - Medicine-related support service, e.g. specific testing prior to prescription (such as
genetic testing or biomarkers). Where the use of a medicine requires specific
testing prior to prescription, companies can arrange to provide such testing as a
package deal even when the outcome of the testing does not support the use of the
medicine in some of those tested. - Patient education services, e.g. service of a health professional to educate patients
on the medicine that has been prescribed to them. - Patient support service, e.g. a telephone line.
- Digital tools, e.g. remote monitoring. Companies will need to consider all relevant
regulations including medical devices regulations, data privacy and MHRA guidance
on software and artificial intelligence as a medical device.
The guidance continues under the following headings:
| Guidance | Pages No |
|---|---|
| 2. Governance of package deals a. Policies b. Classification and certification c. Training and supervision of service providers d. Use in accordance with licence e. Value f. Prohibition on inducements, anti-competitive behaviour and other laws g. Transparency/declaration of funding h. Termination considerations i. Written agreements | Pages no 5-8 |
| 3. Communication to health professionals and other relevant decision makers | Page 9 |
| 4. Disclosure of transfers of value related to a package deal a. Determining whether a package deal is an ordinary course purchase b. Disclosing package deals that are not ordinary course purchases c. Disclosure UK – transfers of value category d. Flow diagram | Pages 9 – 12 |
| 5. Q&As | Page 13 |
Further reading
UK PMCPA releases new guidance on Package Deals: key takeaways for industry, Libby Amos-Stone et al, 4 February 2026, BioSLice Blog, Arnold & Porter.