Calling for Clarity

As 2020 is coming to its end, Europe braces itself for the finalization of the Brexit transition period. On 1 January 2021, the United Kingdom will leave the European Union single market and customs union, which will impact many sectors throughout the region, including the bio/pharma industry.

The negotiations between the UK and EU have encountered some difficulties, and at the time of writing, it is looking more likely that the UK will leave without a deal in place, which means it will move forward in 2021 under the rules of the World Trade Organization (WTO). However, Northern Ireland, which is included in the UK, will continue to follow certain EU rules as a result of the Northern Ireland protocol—presented to the European Council in October 2019 (1).

Bio/pharma companies working in the European region with a presence in Great Britain (England, Scotland, and Wales) and Northern Ireland, are, therefore, calling for clarity on what the end of the transition period will mean for the lawful movement of goods and continuation of compliance across the UK.

Concerns with compliance

In written evidence, submitted to the UK parliament’s Committee on the Future Relationship with the European Union inquiry, Bristol Myers Squibb (BMS) highlighted concerns around access to medicines in Northern Ireland as a result of potential packaging compliance issues (2). BMS wrote, “Currently we are concerned that UK packs of medicines supplied to Northern Ireland may not be compliant with EU regulations after the end of the transition period, meaning companies are at risk of not being able to lawfully dispense them in Northern Ireland.”

BMS specified that part of the concern is in relation to the Falsified Medicines Directive (FMD), which is an EU regulation set out to protect patients from counterfeit medicines (3). “Critical questions remain including whether packs of medicines may be moved from Great Britain to Northern Ireland and dispensed lawfully, if there will be access in Northern Ireland to the relevant FMD databases to track and release medicines, and how medicines for the Northern Ireland market should be packaged,” BMS wrote (2).

Affirming the concerns raised by BMS, the global trade body, International Hologram Manufacturers Association (IHMA), issued a statement urging pharmaceutical manufacturers to review anti-counterfeiting plans in the case of a no-deal scenario (4). “Failure to secure a Brexit deal could leave the door wide open to crafty criminals, who are infiltrating global supply channels, deploying scams and counterfeiting measures to trick consumers and damage manufacturers,” said Paul Dunn, chair of IHMA (4).

Additionally, COVID-19 is providing further opportunities for counterfeiters as more people seek medicines and drugs from online sources due to increased demand and shortages, IHMA stated (4).

Potential scenarios

There are three possible scenarios facing the UK and EU following the transition period—no-deal, a simple free-trade agreement (FTA), or an FTA that includes a mutual recognition agreement (MRA). According to research commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the latter scenario is in the best interest of European pharma (5).

“There is a clear choice available to the EU which mitigates the impact of changes to the EU-UK relationship and supports the region’s resilience and economic recovery,” said Nathalie Moll, EFPIA director general, in a press release discussing the research results (6). “If we fail to get the relationship right then Europe will continue to lose ground to other regions … A free-trade agreement with the inclusion of an MRA is the best way to protect our global competitiveness, our resilience, and our economic recovery.”

For further discussion on the topic of Brexit, including the Northern Ireland protocol, and its impact on the bio/pharma industry, take a look at “Dealing with No Deal” on pages 37–39. And stay alert, stay safe, stay healthy.

References

1. UK Gov., “New Protocol on Ireland/Northern Ireland and Political Declaration,” gov.uk, Policy Paper, 17 October 2019 (Updated 18 October 2019).
2. UK Parliament, “Written Evidence Submitted by the Bristol Myers Squibb (BMS) (FRE0141),” committees.parliament.uk, 14 Oct. 2020.
3. EC, “Falsified Medicines,” ec.europa.eu [Accessed 28 Oct. 2020].
4. IHMA, “Pharmas Urged by Trade Body to Review Anti-Counterfeiting Plans Ahead of No Brexit Deal,” Press Release, 23 Oct. 2020.
5. EFPIA, “Impact of the EU-UK Future Trade Relationship on the European Pharmaceutical Industry,” efpia.eu (July 2020).
6. EFPIA, “Free Trade Agreement with MRA in the Best Interest of European Pharma, Says New Research,” Press Release, 23 July 2020.

About the Author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

Article Details

Pharmaceutical Technology Europe
Vol. 32, No. 11
November 2020
Page: 5

Citation

When referring to this article, please cite it as F. Thomas, “Calling for Clarity,” Pharmaceutical Technology Europe 32 (11) 2020.