“Safeguarding public health must be number one priority” for EU27 and UK Government in phase two of Brexit talks
To coincide with today’s House of Commons Health Select Committee on ‘Brexit: the regulation of medicines, medical devices and substances of human origin’, the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) have published new research on the public health implications of Brexit.
Giving evidence to the committee today, Steve Bates, CEO of the BIA, will use the research to urge the Governments of the EU and the UK Government to “safeguard public health in the UK and Europe by making the regulation and supply of medicines the first priority in phase two of Brexit talks.”
The new report ‘Public Health and Economic Implications of the United Kingdom Exiting the EU and the Single Market’ produced by OHE Consulting, shows that the public health implications of Brexit will become more severe if public health cooperation and trade relationships decline and will have a detrimental effect on patients across the European Union, the European Economic Area (EU27 / EEA) and in the UK.
In the event of Europe and the UK no longer cooperating as they do today on medicines and public health, key findings show:
- The sharing of important drug safety information or information relating to adverse medical events could face a five month delay.
- Europe’s management of large-scale emerging public health concerns or crises – such as the Zika virus – could be at risk.
- A potential for increased frequency of medicines shortages due to administrative burden, customs delays and tariff measures.
The research assesses the consequences arising from legal and regulatory changes associated with Brexit based on four scenarios1 – from full EU/UK cooperation on public health and trade to no cooperation. In Brexit scenarios where the UK fails to negotiate continued participation in public health activities or a free trade agreement (FTA), medicines safety, incident and crisis response to public health threats and the medicines supply chain are all found to be detrimentally effected in Europe and the UK.
Speaking to the select committee, BIA CEO, Steve Bates will say:
“This report highlights to negotiators on both sides of the channel, the scale of the issue in safeguarding public health. With 82 million patient packs travelling between the UK and EU each month, it is vital that teams on both sides of the channel make patient safety a priority. The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks and industry needs a realistic transition period to ensure that the supply of lifesaving and life extending medicines to patients in the UK and across Europe is not affected.”
Mike Thompson, ABPI CEO, added:
“While a breakthrough on 'sufficient progress' is a significant step forwards – this momentum must now be carried forward to prioritising the issues that matter the most to people in the EU and the UK in the next round of talks.
This report highlights the very real consequence of failing to get this right for patients and the public and we will continue to work to mitigate these risks as the UK leaves the EU.
However, a swift cooperation agreement between the EU and the UK on medicines is the only way to ensure that there is no disruption to 500m patients accessing the best possible healthcare and getting the medicines they need.”
Analysis from the report highlights three significant public health concerns:
1. Medicines safety in the EU27 / EEA and the UK
Based on an analysis of communication between the European Medicines Agency (EMA) and non-EU authorities, the report finds that in scenarios where the UK’s expertise is lost from the current network, the detection of ‘signals’ – information relating to a possible causal relationship between an adverse event and a drug – could be delayed by up to five months and the publication of safety recommendations relating to these ‘signals’ could also be delayed by the same amount of time2. In 2016, 2,076 potential signals were reviewed by the EMA3.
The report finds that the UK has detected the greatest number of signals of all EU27 / EEA countries since 20124. In Brexit scenarios 2, 3 and 4, the UK’s expertise will no longer be directly and immediately available to the EU27 / EEA, nor the EU’s to the UK.
The report further demonstrates the strength of the UK’s role in reporting and evaluating the safety of medicines. Analysis shows that the UK hosts the highest number of centres for the conduct of pharmacoepidemiology studies5 – studies that aim to monitor and improve the use of medicine on a population-wide basis.
The UK also hosts the highest number of post-authorisation safety studies (PASS) centres in the EU27 / EEA and also conducts half of all EU27/EEA PASS6. Following the regulatory approval of a medicine, PASS further monitor the safety and benefit-risk profile of a medicine and evaluate any risk-management plans in place.
2. Public health threat management activities in the UK and EU27 / EEA
The report identities that Europe’s management of large-scale emerging public health concerns or crises related to the use of medicines could be at risk. The report finds that in scenarios where the UK would be excluded from the EU Regulatory Network Incident Management Plan, delays in communication around crisis management or divergence in standards and procedures between the EU27 / EEA and the UK are likely to lead to delays in action. This incident management plan is found to be used on average 9-10 times a year7.
Health authorities and regulators from outside the EU are not part of this communication network.
The report also finds that in Brexit scenarios where EU27 / EEA and UK collaboration does not take place, the timely availability of vaccines and the monitoring of the safety profile of medicines administered to large populations, in the event of a pandemic or continent-wide public health threat, could be at risk8.
Case study: In 2015, when the spread of Zika virus infections raised worldwide concern, the Europe, including the UK, contributed their shared expertise to the global response to this threat and gave advice on scientific and regulatory matters regarding research and development of medicines or vaccines against the virus.
The EMA and competent authorities in Member States, which include the UK’s MHRA, also carried out an assessment of plasma-derived or urine-derived medicines and concluded that there is no increased risk of contamination with the Zika virus for patients who take these medicines.
This collaborative regulatory network delivered reassurance that even if plasma or urine came from donors who had contracted the Zika virus, there is no risk of the virus contaminating the final products and thus affecting the patients taking them9.
3. Medicines supply in the UK and EU27 / EEA
The report finds that changes to trade and the medicines supply chain as a result of Brexit could contribute to an increased frequency of medicines shortages in the EU27 / EEA and the UK. A recent survey by the European Federation of Pharmaceutical Industries and Associations has found that 45 million packs of medicine go from the UK to the EU27 / EEA each month – with over 37 million packs coming back the other way10.
For the EU27 / EEA, the impact of the UK becoming a ‘third country’ would be felt the most on vaccines and advanced therapies that use human blood/plasma, as these products are disproportionately manufactured or imported via the UK11. These impacts are likely to be particularly acute during any implementation period where pharmaceutical companies have to duplicate or relocate batch release testing (a critical part of Good Manufacturing Practice (GMP) and a final safety check that pharmaceutical manufacturers must perform before a medicine is released for use).
The report also demonstrates risk relating to delays in the supply of medicines coming from outside the EU. The UK has the highest number of sites certified to import pharmaceuticals from ‘third countries’, ahead of Germany12. Currently, pharmaceutical products from ‘third countries’ certified at sites in the UK can be readily dispatched to the EU27/EEA freely through the single market and customs union.
The analysis concludes that in a Brexit scenario where the UK and the EU fail to reach a trade agreement on pharmaceuticals, medicines will be subject to tariff and non-tariff measures that could increase administrative burden, cause customs delays and increase costs.
The full report can be downloaded here
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]
5As 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’, 8 November 2017: https://www.efpia.eu/media/288531/brexit-survey-outcome-08112017.pdf [Accessed 1 Dec 2017]
11 See Executive Report, page 23 12The UK has 357 sites certified to import from third countries. Germany has 262 sites. [See Executive Report, page 27]
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.
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