Pharmaceutical compliance glossary

ABPI Code of Practice

The UK pharmaceutical industry’s self-regulatory code for the promotion of medicines and interactions with health professionals, other relevant decision makers, healthcare organisations, patient organisations and the public. The 2024 Code took effect on 1 October 2024. PMCPA: 2024 ABPI Code

Adequate procedures

The defence to the Bribery Act 2010 section 7 offence. Ministry of Justice guidance sets out six principles: proportionality, top-level commitment, risk assessment, due diligence, communication (including training), and monitoring and review. MoJ Bribery Act guidance

Aggregate disclosure

Publishing transfers of value as totals, with the number of recipients, rather than by individual name, for example where individual disclosure is not possible for legal reasons. R&D transfers of value are disclosed in aggregate under the EFPIA Code. EFPIA disclosure guide

AI literacy

Under Article 4 of the EU AI Act, as amended, providers and deployers must take measures to support the development of AI literacy of staff who use AI systems on their behalf. EU AI Act for pharma

AQP signatory

An appropriately qualified person signatory, who may certify events and meetings involving travel outside the UK under Clause 8.2 without being a doctor or pharmacist. PMCPA: Clause 8

Associated person

Under the Bribery Act and the failure to prevent fraud offence, someone who performs services for or on behalf of an organisation, such as an employee, agent, subsidiary or service provider. Failure to prevent fraud guide

CAPA

Corrective and preventive action: a plan that identifies root causes, actions, accountable owners, due dates and effectiveness checks. Pharma compliance audits

Certification

Formal sign-off, under Clause 8 of the ABPI Code, of promotional material in its final form by a nominated signatory before it is issued. Material still in use must be recertified at least every two years. ABPI signatory guide

Clause 2

The ABPI Code clause titled Upholding Confidence in the Industry. In our 2026 sample of 12 completed cases, four included a breach of Clause 2. Lessons from recent PMCPA cases

Contracted services

Services such as consultancy or advisory boards provided by HCPs or others under contract. Clause 24 of the ABPI Code addresses legitimate need, selection, advance written contracts and fair market value. PMCPA: Clause 24

Disclosure UK

The ABPI’s central database of transfers of value from pharmaceutical companies to UK health professionals and healthcare organisations, published at the end of June each year. Disclosure UK guide

EFPIA Code of Practice

The European pharmaceutical industry code setting standards for interactions with HCPs, HCOs and patient organisations, including annual disclosure of transfers of value. Member associations transpose it into national codes and may adopt stricter standards. EFPIA disclosure guide

EU AI Act

Regulation (EU) 2024/1689, the EU law on artificial intelligence, applying in stages from February 2025, with high-risk dates amended by the 2026 AI Omnibus. EU AI Act for pharma

Failure to prevent fraud

A corporate offence under the Economic Crime and Corporate Transparency Act 2023, in force since 1 September 2025, for large organisations whose associated persons commit specified frauds intending to benefit them. Failure to prevent fraud guide

Fair market value (FMV)

Compensation for an HCP’s services that reflects a reasonable rate for the work, based on a documented methodology. Clause 24 of the ABPI Code requires remuneration for contracted services to reflect fair market value. FMV methodology case study

Gap analysis

A comparison of regulatory obligations, industry standards and internal commitments with how the business actually operates, to assess current effectiveness and future readiness. Compliance gap analysis

HCO

Healthcare organisation, such as a hospital, clinic or professional body. The ABPI states that information about HCOs is not personal data. Disclosure UK guide

HCP

Healthcare professional. Disclosure of an HCP’s name alongside a transfer of value is personal data and needs a lawful basis under data protection law. GDPR and transparency reporting

Legitimate interests

A lawful basis for processing personal data under Article 6(1)(f) of the GDPR, which the ABPI champions for Disclosure UK. Individuals keep the right to object. GDPR and transparency reporting

Loi Bertrand

France’s transparency law (Loi n° 2011-2012), often called the French Sunshine Act, requiring companies to disclose agreements with and benefits to healthcare stakeholders on Transparence Santé. France guide

Methodology note

A note each company publishes explaining how it prepared its disclosures. Under the EFPIA Code 2026, HCP/HCO notes follow the mandatory structure in Annex B. Methodology note template

PMCPA

The Prescription Medicines Code of Practice Authority, which administers the ABPI Code independently of the ABPI and publishes completed cases. PMCPA case library

Signatory

The person who certifies material on behalf of a company under the ABPI Code: for promotional material, a registered medical practitioner or UK-registered pharmacist (or a dentist for dental-only products). Signatories are notified to the MHRA and the PMCPA. ABPI signatory guide

Transfer of value (ToV)

A payment or benefit in kind from a company to a healthcare professional, healthcare organisation or patient organisation, such as fees for services, contributions to event costs, or donations and grants, which may need to be disclosed. EFPIA disclosure guide

Transparantieregister Zorg

The Dutch register of financial relationships of at least €500 a year between companies and HCPs, institutions and patient organisations. Netherlands guide

Informational definitions, not legal advice. Sources checked 30 September 2026.