Glossary

This glossary provides clear, consistent definitions of key terms used across ABPI publications, policy positions, consultations, and digital content. It is intended to support shared understanding among members, policymakers, partners, media, and the public.

A

AAC

Accelerated Access Collaborative

ATW

Advanced Therapies Wales Programme

ATMPs

Advanced therapy medicinal products

Medicines based on genes, tissues or cells, which offer new opportunities for the treatment of disease and injury.

ADR

Adverse Drug Reaction

A response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.

Adverse event

An unfavourable and unintended experience associated with the use of a medical product in a patient, which may or may not be causally related to the medicine

AWDCC

All Wales Drugs Contracting Committee

AWMSG

All Wales Medicines Strategy Group

AWPAG

All Wales Prescribing Advisory Group

AWTTC

All Wales Therapeutics and Toxicology Centre (Secretariat to AWMSG)

AHP

Allied Health Professional

Alternative technologies

Non-animal models that can be used in research

AMR

Antimicrobial Resistance

AI

Artificial Intelligence

AMRC

Association of Medical Research Charities

AoMRC

Association of Medical Research Charities

ABPI

Association of the British Pharmaceutical Industry

ASAR

AWMSG Secretariat Assessment Report

The All Wales Medicines Strategy Group

B

Biosimilar

A biological medicine which has been shown not to have any clinically meaningful differences from the originator medicine in terms of quality, safety and efficacy

BDA

British Dental Association

BMA

British Medical Association

BNF

British National Formulary

BIT

Budget Impact Test

C

CDF

Cancer Drugs Fund

A source of funding that enables patients to access promising cancer medicines while additional evidence is collected.

CNCI

Category Normalised Citation Impact

Citation rates vary between research fields and with time. Consequently, analyses must take both publication field and year into account. In addition, the type of publication will also influence the citation count. For this reason, only citation counts of papers (as defined below) are used in calculations of citation impact. The standard normalisation factor is the world average of citations per paper for the year and subject category in which the paper was published. This normalisation is referred to as ‘rebasing’ the citation count. A CNCI value of more than 1.0 indicates performance higher than the world average for the relevant publication field, year, and document type.

Cell and Gene Therapy Catapult

An independent innovation and technology organisation committed to the advancement of cell and gene therapies.

CMO

Chief Medical Officer

COPD

Chronic Obstructive Pulmonary Disease

Citation count

The citation count is the number of times that a citation has been recorded for a given publication since it was published. Not all citations are necessarily recorded since not all publications are indexed. The material indexed by Clarivate, however, is estimated to attract about 95% of global citations.

Citation impact

Citations per paper is an index of academic or research impact (as compared with economic or social impact). For a single paper, raw citation impact is the same as its citation count. For a set of papers, it is calculated by dividing the sum of citations by the total number of papers in any given dataset. Impact can be calculated for papers within a specific research field such as clinical neurology, or for a specific institution or group of institutions, or a specific country. Citation count declines in the most recent years of any time period as papers have had less time to accumulate citations.

Clinical cohort

Research programme and/or infrastruture which involved collection and storgae of samples and clinical data derived from individuals with a pre-determined condition

CEPP

Clinical Effectiveness Prescribing Programme

CRO-mCTA

Clinical Research Organisation Model Clinical Trial Agreement

Clinical trial

Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other effects of a medicine

Clinical trial sponsor

The organisation that has overall responsibility for running the clinical trial. This can be different from the organisation that funds the research.

Code of Practice

An ABPI document which sets out the requirements the industry must comply with and supports companies’ commitment to self-regulation

Collaborative working

Collaborative working is generally between one or more pharmaceutical companies, healthcare organisations and possibly other organisations. It must have, and be able to demonstrate, the pooling of skills, experience and / or resources from all parties involved

CAA

Commercial Access Agreement

Commercial collaborative studies

Commercial collaborative studies are typically funded, either wholly or in part, by the life sciences industry and sponsored by a combination of industry and non-commercial organisations.

CHC

Community Health Council

CPCF

Community Pharmacy Contractual Framework

CPW

Community Pharmacy Wales

Company-Sponsored Digital Activity

A digital activity is considered to be company-sponsored if it is owned, paid for and/or controlled by the company. Control means that the company has authority over the final content. A donation (financial or otherwise) to an organisation/site by a marketing authorisation holder does not constitute ownership, provided that the marketing authorisation holder does not control the final content of the site. A company may sponsor a ‘page’ on a website/platform that they do not own (e.g. a social media or micro-blogging site). If the company has control over the content of a sponsored page, it is considered company-sponsored.

CHD

Coronary Heart Disease

CIOMS

Council for International Organization of Medical Sciences

Chief Pharmaceutical Officer

CPO

D

Data (Use and Access) Bill

A proposed Government Bill with implications for health data sharing.

Data access policy

Changes to how NHS data is accessed including the move from a system of data sharing to a system of data access.

DARS

Data Access Request Service

NHS England’s gateway to accessing NHS health and social care data.

Data asset

A collection of data that has value for research, such as the UK Biobank.

Data linkage

The process of connecting different datasets for a more comprehensive analysis.

DHSC

Department of Health and Social Care

DHCW

Digital Health and Care Wales

Digital Health and Care Wales (DHCW) is the national digital health and care organisation in Wales. It is a specialist body within the NHS Wales family tasked with leading, developing, and delivering digital and data services that support the delivery of health and care across Wales.

Disclosure

Industry showing payments and benefits in kind made by the pharmaceutical company

E

Efficacy

The ability of a medicine to produce its desired effect.

EMA

European Medicines Agency

EMA

European Medicines Agency

The European agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
https://www.ema.europa.eu/en/homepage

EU

European Union

F

FMV

Fair Market Value

The price at which a medicine would be sold between a willing buyer and a willing seller, acting independently, with full knowledge of relevant facts, and without any pressure or coercion. A price that reflects production cost, R&D, distribution, and a reasonable profit that is comparable to similar drugs in the same therapeutic class. FMV may be used to determine reasonable reimbursement levels in publicly funded health systems.

G

GDPR

General Data Protection Regulation

Generic

Pharmaceutical drug that contains the same chemical substance as a branded drug that was originally protected by chemical patents.

GLH

Genomic Laboratory Hub

A network of 7 GLHs is responsible for coordinating and delivering national genomic testing service.

GMS

Genomic Medicine Service

The arm of the NHS working to enable the NHS to harness the power of genomic technology and science.

Genomics England

Company wholly owned by government that analyses sequenced genomes for the NHS and provides genomic data for research.

GMP

Good Manufacturing Practice

GVP

Good Vigilance Practice

GCSA

Government Chief Scientific Adviser

GDP

Gross domestic product

Gross domestic product - measures the value of goods and services produced in a country, to estimate the size of the economy and its growth.

GVA

GVA (direct, indirect, and induced)

Gross value added (GVA) measures the contribution of a specific sector to the overall economy. GVA impacts are often split into direct, indirect, and induced impacts. Direct impacts refers to changes in the value of goods and services produced by that industry. Indirect impacts refer to changes in the use of inputs across their supply chain. Together, direct and indirect impacts will impact the level of household income of employees, some of which will be re-spent on buying products. This known as the induced impact.

H

HCRW

Health and Care Research Wales

The network that supports and coordinates health and care research across Wales.

HSC

Health and Social Care

HSC R&D

Health and Social Care Northern Ireland R&D Division

This funds and coordinates health and care research across Northern Ireland.

HDRS

Health data research service

A service providing secure access to health data for research and development purposes.

HIRANI

Health Innovations Research Alliance Northern Ireland

Health Innovation Research Alliance Northern Ireland (HIRANI) is a not-for-profit, collaborative organisation established to strengthen and grow the Life & Health Sciences ecosystem in Northern Ireland. Founded in 2019, it acts as the cluster organisation and single strategic voice for the region’s health and life sciences sector, bringing together academia, healthcare providers, industry, government and investment partners to drive innovation, collaboration and economic impact.

HRA

Health Research Authority

HTA

Health Technology Assessment

HCP

Healthcare Professionals

HST

Highly Specialised Technologies

I

In silico

Research and experiments conducted via computer simulation and virtual models rather than a physical laboratory setting.

In vitro

Research and experiments conducted outside of a living organism, typically in a controlled laboratory environment.

In vivo

Research and experiments conducted inside of a living organism.

ICER

Incremental cost-effectiveness ratio

A summary measure that represents the economic value of a healthcare intervention when compared with an alternative (comparator). An ICER is calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome or effect (incremental effect).

Indication

The disease, symptom, or condition that a medicine is officially approved to treat, prevent, or diagnose

ICSR

Individual Case Safety Report

Industry clinical trials

Industry clinical trials (also known as commercial contract studies) are sponsored and fully funded by the life sciences industry.

IMF

Innovative Medicines Fund

A managed access fund to support patient access to promising non-cancer medicines.

Innovative payment model

Any approach affecting the reimbursement or funding of a medicine beyond the routine market-access pathways.

ICB

Integrated Care Board

Statutory NHS organisation responsible for planning and funding most health services in a local area in England. Created by the Health and Care Act 2022.

IP

Intellectual Property

The ideas and innovations that underpin the new products (medicines and vaccines) our companies create. Promotion and protection of IP helps to enable the innovation cycle so that companies can reinvest into new discoveries.

J

Joint Working

Joint working projects are a specific type of NHS-industry collaborative working, rather than a generic term for all cross-sector collaboration. They must be patient-centred and always benefit patients directly, which gives them a narrower focus than collaborative working.

L

Licensed

Stipulates the medicine can be used to treat certain conditions.

LOWMAG

Licensed One Wales Medicines Assessment Group

Longitudinal data

Data collected over a long period to track changes and trends.

LOE

Loss of exclusivity

The date when a branded drug's patent protection or regulatory exclusivity expires, allowing generic or biosimilar manufacturers to enter the market.

M

Managed access

An approach that allows patients to access medicines while further evidence is generated.

Marketing authorisation

A legally binding licence issued by a regulatory body (e.g., MHRA, EMA) confirming a medicine meets necessary quality, safety, and efficacy standards for sale. No medicine can be legally marketed without this.

MAH

Marketing Authorisation Holder

Medical Affairs

The part of a pharmaceutical companies which engages with healthcare professionals regarding the clinical aspects of products.

MHRA

Medicines and Healthcare products Regulatory Agency

Medicines Optimisation

Ensuring the best outcome from using or not using a medicine.

MOIC

Medicines Optimisation Innovation Centre

Is a regional centre of excellence that focuses on promoting and supporting the optimal use of medicines in health and social care. Its goal is to improve patient outcomes, enhance medication safety, and ensure value for money through innovation and best practice in medicines use.

Multimorbidity

The presence of two or more long-term health conditions.

N

National Data Library

A proposal from the Labour Party Manifesto to “bring together existing research programmes and help deliver data-driven public services.

NICE

National Institute for Health and Care Excellence

The organisation responsible for providing national guidance and advice to improve health and social care.

NIHR

National Institute for Health and Care Research

The organisation that funds and delivers health and social care research in England.

NHS 10 Year Health Plan

The government's plan to deliver an NHS fit for the future.

NHS commissioning support units

Independent units that provide commissioned services back to the NHS.

NHS England

NHS England leads the National Health Service (NHS) in England.

NHS England Secure Data Environment

NHS England’s Secure Data Environment platform providing access to nationally collected data sets, formerly the responsibility of NHS Digital.

NRS

NHS Research Scotland

The organisation that supports and coordinates health research activity across Scotland.

NAM

Non-animal model

Non-commercial studies

Non-commercial studies are sponsored and wholly funded by one or more non-commercial organisations, including medical research charities, universities, and public funders.

Non-Company-Sponsored Digital Activity

A digital activity is considered to be non-company-sponsored if it is not owned, paid for or controlled by the company. For such a digital activity, there must be no possibility that the pharmaceutical company has been able to exert any influence or control the final content. A donation (financial or otherwise) to an organisation/website by a pharmaceutical company does not constitute sponsorship provided that the pharmaceutical company does not control the final content of the digital activity.

NHP

Non-human primate

O

Off-label

Using a medicine in a way that is different to described on the product licence.

Omics data

Biological data related to genomics, proteomics, or other molecular-level information.

OWMAG

One Wales Medicines Advisory Group

OpenSAFELY

NHS England commissioned software platform for analysis of electronic health records data.

Outcomes-based agreement

A payment arrangement in which reimbursement is linked to the outcomes achieved by a medicine.

OTC

Over the counter medicine

Overprescribing

Potential harm outweighs the benefit of the medication but it is given anyway.

P

Papers

A subset of publications consisting of ‘articles’ and ‘reviews’ only. Articles are reports of original research published in a peer-reviewed journal and/or presented at a symposium. Reviews are renewed studies of previous research, such as literature reviews and meta-analyses. Papers are the primary means of scholarly communication and considered the most informative for citation analysis. All citation-related results in this report (except patent citations) are therefore based on papers only.

Patent

Exclusive legal right granted for a new invention, such as a medicine, allowing the owner to prevent others from making, using, or selling the invention for a limited time.

Pathophysiology

The physiological processes associated with a disease.

PPI

Patient and Public Involvement

The active partnership of patients, carers, and members of the public in the design, delivery, evaluation, and governance of healthcare services and research, not as participants, but as contributors and decision-makers.

PPIE

Patient and Public Involvement and Engagement

A wider term than Patient and Public Involvement to also include engaging and communicating more widely about research with patients and the public.

Patient Organisation Forum

The ABPI hosts a Patient Organisation Forum for registered patient/health charities to come together with each other and pharmaceutical companies to network and learn. The Forum has a shared goal of supporting equitable access to research and innovation for UK patients.

PSUR

Periodic Safety Update Report

PV

Pharmacovigilance

Activities relating to the detection, assessment, understanding and prevention of adverse effects.

PMMT

Pharmacy and Medicines Management Team

Is part of Northern Ireland’s Health and Social Care system, operating within the Strategic Planning and Performance Group (SPPG). It is responsible for clinical governance, quality assurance, service development and medicines optimisation across community pharmacy and medicines management services.

Polypharmacy

Used to describe the situation when people are taking a number of medicines.

Post-marketing surveillance

The practice of monitoring the safety of a pharmaceutical drug after it has been approved for use.

Pre-clinical model

Lab-based, computer-base animal-based research tools, designed to mimic human biology as closely as possible and used to understand human biology and test potenteial therapeutic candidates.

Pre-clinical research

All medical research that occurs prior to clinical research. This includes basic research, discovery,translational research and pre-clinical studies (animal studies).

PMCPA

Prescription Medicine Code of Practice Authority

POM

Prescription Only Medicine

PC

Product Complaint

Product complaints are a customer’s written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a product after it is released for distribution.

PPP

Public-private partnership

A collaboration between government and private companies for service delivery.

Publications

A collection of research outputs regardless of document type, as indexed in the Web of Science. In addition to articles and reviews, publications can cover a wide range of document types such as books, conference proceedings, editorial material, bibliographies, meeting abstracts, etc. While these are all relevant forms of scholarly communication, only articles and reviews (that is, papers) are considered in citation analyses.

Q

QPPV

Qualified Person for Pharmacovigilance

QALY

Quality-adjusted life year

A health economics measure combining the length and quality of life into a single unit, used to evaluate treatments and policies, where one QALY equals one year of life in perfect health.

R

Real world evidence

The clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of real world data.

Regional SDE

Secure data environment providing access to health data at a regional level.

Resected tissue

A small piece of tissue cut out.

RMP

Risk Management Plan

Submitted by companies when applying for their medicine to be able to be used, details how a medicines risks will be prevented or minimised in patients.

S

SI

Safety Information

Adverse event; use during pregnancy; exposure during breast-feeding; overdose; drug abuse or misuse; medication errors; unapproved or off-label use; reports of lack of therapeutic effect associated with an adverse event; drug-drug or drug-food interactions; suspected transmission of an infectious agent; occupational exposure.

Severity modifier

A NICE appraisal mechanism that gives higher value to treatments for severe illnesses, which could increase the changes of reaching cost-effectiveness and being approved.

Siloed data

Data stored separately without easy access across systems.

Specialised Commissioning

The process of planning, securing, and monitoring specialised health services for patients with rare, complex, or high-cost conditions, such as cancer, genetic disorders, and specialized mental health needs. Generally managed at a national level by NHS England.

Spread payments

A payment approach in which the cost of a medicine is divided into instalments over time.

SPPG

Strategic Planning and Performance Group

Is a directorate within Northern Ireland’s Department of Health. It oversees how health and social care services are planned, commissioned, and managed across the Health and Social Care system.

Sudlow Review

An independent review highlighting the need for unified health data access in the UK.

SmPC

Summary of medicinal Product Characteristics

T

Therapeutic class

A way of grouping medicines by their intended effect.

TRE

Trusted Research Environment

A secure environment that allows sensitive data to be accessed and analysed without the data leaving the platform. Also referred to as Data Safe Haven or Secure Data Environment (SDE).

U

UK Biobank

A biomedical database and research resource, established as a charity in 2006, containing data and samples from half a million UK participants.

User-centred design

A process that focuses on what users need throughout development.

V

Variation

A variation is a change to the terms of a marketing authorisation.

Vascularisation

The process through which blood vessels develop in tissues and organs.

W

Web of Science subject categories

Journals are assigned to one or more categories, and every article within that journal is subsequently assigned to that category. Journals in the Web of Science Core Collection can be assigned to up to six categories, which are selected on the basis of a range of criteria including journal subject matter and scope, author and editorial board affiliations, funding agencies providing grant support, cited references as well as citing and cited reference relationships, journal sponsors, and categorisations in other bibliographic databases. The selection procedures for the journals included in the citation databases as well as the scope of each subject category are documented here: http://mjl.clarivate.com/.

WHO

World Health Organization

A specialised agency of the United Nations which coordinates global responses to public health issues and emergencies, as well as sets the rules for some aspects of research, development and investigation into disease.

WIPO

World Intellectual Property Organization

A specialised agency of the United Nations created to protect and promote intellectual property internationally. Through WIPO countries can shape IP rules that set the terms of business for sectors like the pharmaceutical industry.

WTO

World Trade Organization

A multilateral institution which regulates and sets the terms for global trade and international rules for business.

Y

Yellow Card Scheme

The system for recording adverse incidents with medicines and medical devices in the UK.