About the ABPI

The ABPI represents innovative resea​rch-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.

Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome disease.

Globally our industry is researching and developing more than 7,000 new medicines.

The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.​​​​​​​

Notes to editors

1. About this report

'Public Health and Economic Implications of the United Kingdom Exiting the EU and the Single Market' was produced by OHE Consulting and was commissioned by the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) to provide important evidence for the ongoing policy analysis into the implications of the UK leaving the European Union.

2. About the current medicines safety system

The system for reporting and evaluating the safety of medicines is conducted across Europe. It relies on information gathered and shared between the European Medicines Agency (EMA), national regulatory authorities (such as the UK's MHRA) and marketing authorisation holders (i.e. a pharmaceutical company). These activities include:

Signal detection – a 'signal' is information reported on a possible causal relationship between an adverse medical event and a drug. These data are gathered and made available in the electronic EudraVigilance database. This process aims to find, as soon as possible, any indication of an unexpected drug safety problem that may require further investigation by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).

Post-authorisation safety studies (PASS) – following the approval of a medicine, this process further monitors the safety and benefit-risk profile of a medicine and evaluates any risk-management plans (RMP). Pharmaceutical companies are required submit a RMP plan to the European Medicines Agency (EMA) when applying for a marketing authorisation. RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available.

Pharmacoepidemiology studies – this process aims to improve medication use on a population-wide basis and strengthens the monitoring of the benefit-risk profile of a medicine. These studies are gathered in the electronic EU PAS Register.

3. About the current system for tracking, monitoring and responding to public health threats

The European health network plays a proactive role in global efforts to respond to existing and emerging public health threats such as antimicrobial resistance, the risk of falsified medicines, biological and chemical threats and emergencies such as an outbreak or a pandemic (such as Ebola, pandemic influenza and Zika virus outbreaks).

The EU Regulatory Network Incident Management Plan aims to ensure that health and regulatory bodies and pharmaceutical companies take appropriate action whenever incidents (new events or information) arise concerning the safety and quality of all human medicines. This plan also monitors supply shortages caused by manufacturing problems. The Commission also draws on the expertise of the EMA and national regulators to coordinate preparedness and response in the event of pandemics in collaboration with other European public health institutions and agencies of the United Nations.​

4. About the current medicines supply chain

Batch release testing is a critical part of the medicines supply chain and is a final safety check that pharmaceutical manufacturers must perform before a medicine is released for use. Manufacturers must thoroughly analyse samples to check that the product meets all safety and quality controls and not a single dose from a batch will reach a patient until a Qualified Person (QP), who is responsible for ensuring that a product meets all release criteria, signs off the batch.

Within the EU28 / EEA batch release testing and sign-off by a QP in any Member State provides authorisation for distribution in all European countries without any further testing. Imported products manufactured outside of the EU28 / EEA must be batch tested at the point of entry prior to release authorisation, except when the EU28 / EEA has a mutual recognition agreement with a third country. Batch release is the final step in a set of quality assurance measures and processes that ensure pharmaceuticals are manufactured in compliance with Good Manufacturing Practice (GMP).

GMP describes the minimum standard that a medicines manufacturer must meet in their production processes. The EMA coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at EU level. Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.


[1] Scenario 1: 'The Medicines and Healthcare products Regulatory Authority (MHRA) remains fully involved in EU27 / EEA public health activities; the UK negotiates free trade agreements (FTAs) with the EU'; Scenario 2: 'The MHRA implements a standalone regulatory system and negotiates agreements with the EU that cover inspections of quality and manufacturing processes (not the releases of batches); the UK negotiates FTAs with the EU'; Scenario 3: 'The MHRA implements a standalone regulatory system and negotiates agreements with the EU that cover inspections of quality and manufacturing processes (not the releases of batches); trade cooperation is regulated by WTO most favoured nation (MFN) agreements'; Scenario 4 'No public health cooperation between the MHRA and the EU27/EEA; trade cooperation regulated by WTO MFN agreements'.

[2] See Executive Report, page 20

[3] For further information, see the European Medicines Agency Annual Report 2016, page 52: http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2017/05/WC500227334.pdf[Accessed 11 December 2017]

[4] Since July 2012 (until data received as of 31st May 2017), 364 signals have been detected, prioritised and assessed by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC). Of these, 51% (186) were identified by EU member states (the others were via the EMA), 21% (39) of which were identified by the UK. [See Executive Report, page 20]

[5] As at the 5th July 2017 the UK hosted 22% of all pharmacoepidemiology centres (35 out of 161). [See Executive Report, page 21]

[6] Between November 2010 and 5th July 2017, the UK conducted nearly 50% of PASS (164 out of 331)..[See Executive Report, page 21]

[7] See Executive Report, page 22

[8] See Executive Report, page 23

[9] For further information, see European Medicines Agency Annual Report 2016, page 18: http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2017/05/WC500227334.pdf[Accessed 11 December 2017]

[10] European Federation of Pharmaceutical Industries and Associations, 'Brexit EFPIA Survey', 8November 2017: https://www.efpia.eu/media/288531/brexit-survey-outcome-08112017.pdf[Accessed 1 Dec 2017]

[11] See Executive Report, page 23

[12] The UK has 357 sites certified to import from third countries. Germany has 262 sites. [See Executive Report, page 27]

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