Regulatory Focus™ > News Articles > 2020 > 10 > Euro Roundup: UK, EU trade groups push Brexit negotiators to act to stop supply disruption

Euro Roundup: UK, EU trade groups push Brexit negotiators to act to stop supply disruption

Posted 01 October 2020 | By Nick Paul Taylor 

Euro Roundup: UK, EU trade groups push Brexit negotiators to act to stop supply disruption

Trade bodies representing the UK and European Union pharmaceutical industries have urged Brexit negotiators to act now to prevent disruption to the supply of medicines. The joint statement warns failing to form a mutual recognition agreement to soften a hard Brexit could cost both sides billions and delay the supply of medicines by up to six weeks.
The latest round of negotiations about the post-Brexit relationship between the UK and EU is due to end on Friday. If sufficient progress has been made, negotiations will enter a new, intensified phase designed to enable the two sides to reach compromises over outstanding points of disagreement. However, with the sides yet to find common ground on important issues including state aid, it remains possible that the UK will split from the EU at the end of the year without a meaningful deal.
The Association of the British Pharmaceutical Industry (ABPI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are alarmed by the prospect of a hard split, leading them to issue a rare joint statement to the Brexit negotiators. The trade groups want the UK and EU to negotiate a mutual recognition agreement (MRA) for medicines manufacturing and establish a one-year phase-in process for the protocol covering Northern Ireland.
The MRA request, which EFPIA originally made in a joint statement with other EU groups in June, reflects fears about the impact of a no-deal Brexit on the 82 million packs of medicines traded between the UK and EU every month. Currently, the EU and UK accept the results of tests and inspections carried out by the other side. That would end in a no-deal Brexit, leading ABPI and EFPIA to warn that retesting of medicines could delay supplies by four to six weeks.
Striking an MRA that is separate from the broader Brexit negotiations, as the EU and US did during the failed Transatlantic Trade and Investment Partnership talks, would enable the two sides to avoid the duplication of batch release and testing. Modeling shared by ABPI and EFPIA suggests an MRA would halve the negative impact on UK pharmaceutical exports of leaving the EU without a free-trade deal.
ABPI and EFPIA also want the UK and EU to delay the application of a protocol that will see medicines in Northern Ireland governed by EU regulations that are enforced by the Medicines and Healthcare products Regulatory Agency (MHRA). The arrangement is designed to avoid a hard border between Northern Ireland and the Republic of Ireland. MHRA has shared some guidance on what the protocol will mean for the pharmaceutical industry, but not enough to satisfy ABPI and EFPIA.
“Without further guidance on new rules and regulations, medicines may not be able to be legally dispensed in [Nothern Ireland] NI from 1 January. It is estimated that this applies to the majority of Northern Ireland’s future medicines supply. With just 15 weeks until the end of the transition period, it is impossible for companies to implement any complex changes that might be required,” the trade groups wrote.
ABPI and EFPIA have asked for a one-year phase-in process “starting from the point when the UK and EU reach agreement on its interpretation” to prevent disruption to the supply of drugs in Northern Ireland.
Joint Statement, Financial Times
Swissmedic outlines impact of upcoming move to electronic submissions
The Swiss Agency for Therapeutic Products (Swissmedic) has outlined the impact of the upcoming move to the mandatory use of the eGov service to share notifications of major changes.
As previously stated, Swissmedic will switch to a fully electronic model of major change notifications at the start of November. This week, Swissmedic shared more information about what that will mean for companies.
Once Swissmedic moves to the electronic system, companies will need an establishment license “according to the new legislation from 1 January 2019,” an eGov login and access to the “Licences – major changes” service to notify the agency of major changes. Swissmedic shared information on how companies can fulfill those requirements in the notice it published this week.
For now, companies can continue to submit all major changes by email or physical post. That will change on 1 November, giving companies around one month to fulfill the requirements for using the eGov notification service.
Swissmedic Notice
MHRA welcomes bill to facilitate undercover investigation of pharmaceutical crime
MHRA has welcomed the introduction of draft legislation to facilitate undercover investigations of pharmaceutical crime in the UK.
For years, undercover officials have participated in criminal conduct to maintain credibility or gain the trust of the people they are investigating. That practice, which is authorized in the UK using a variety of legal bases, was challenged last year. While the tribunal sided with the government, the case nonetheless exposed the shortcomings of the legal framework that permits criminal conduct.
The UK government wants to create a clear and consistent basis for public authorities that need to authorize criminal activity by passing the Covert Human Intelligence Sources (Criminal Conduct) Bill. MHRA, one of the organizations affected by the bill, welcomed the proposals.
“Our Enforcement team works closely with the police in tackling pharmaceutical-based crime, seizing both the products that pose a risk to the public and the proceeds of the crime. These powers clarify and strengthen our ability to uncover links to serious organised crime, when deemed necessary and proportionate,” MHRA chief executive June Raine said.
UK politicians are scheduled to debate the proposed legislation next week.
Press Release, Draft Legislation
Denmark’s DKMA weighs whether to split pharmacovigilance and signal detection
The Danish Medicines Agency (DKMA) has identified the choice between separate or joint systems for pharmacovigilance and signal detection as a key point it needs to resolve before issuing a tender.
DKMA currently collaborates with MHRA on pharmacovigilance. However, with the UK set to leave the EU, DKMA wants to establish its own system. DKMA held a consultation earlier this year, coming away with evidence that an off-the-shelf system can meet its needs. However, DKMA is yet to settle on an answer to one important question.
“The Danish Medicines Agency must clarify the ramifications of a crucial question before deciding on the way forward: Should there be a single tender containing both a pharmacovigilance system and a signal detection and handling system or should there be two separate tenders each containing its separate system?” DKMA wrote in a final report on the consultation process.
Whatever DKMA decides, the agency plans to announce a tender by the start of February. If DKMA opts to split pharmacovigilance and signal detection, it will announce the second tender by the start of May. IQVIA, SAS Institutes and Novo Nordisk-spinout NNIT are among the companies to express an interest in the work.
DKMA Report
Shortage of Pfizer autoimmune drug drives Spain to activate emergency measures
The Spanish Agency of Medicines and Medical Devices (AEMPS) has established a process to enable hospitals to access limited supplies of Pfizer’s disease-modifying anti-rheumatic drug sulfasalazine.
Certain formulations of sulfasalazine, which Pfizer sells as Azulfidine, are in short supply in countries including the US. AEMPS expects the supply disruption that has caused the shortage to drag on into 2021. Initially, AEMPS managed the situation by enabling individual physicians to request access to stocks.
Now, AEMPS has created a different pathway to minimize the workload for healthcare professionals and ensure patients, specifically those with rheumatological diseases, can access the medicine. The new pathway enables hospitals to order stocks for use by multiple physicians. Hospitals will receive an allocation based on the number of patients they treat.
AEMPS Notice (Spanish)


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Tags: EU, UK

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