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Media and Political Bulletin – 19 June 2020

Media and Political Bulletin

19 June 2020

Lord Bethell Thank You Letter to the Healthcare Distribution Sector, 17 June 2020

Please see here for a letter from Lord Bethell, Minister of Innovation at DHSC, thanking all staff in the healthcare distribution sector for their hard work during the COVID-19 pandemic.

Media Summary

Trade groups set out pharma priorities to EU Commission President for EU-UK Brexit negotiations

The Pharma Letter, 18 June 2020

The Pharma Letter reports that the major European pharma trade groups have written to the European Commission president Ursula von der Leyen and other officials, to prioritize health and patients’ access to medicines in the EU-UK Brexit negotiations, and shield them from larger political considerations.

The letter says it is crucial to ensure as much cooperation as possible with regard to regulatory processes and the import and export of medicines and medical supplies across UK/EU borders.

The pharma trade groups say this could be easily achieved with a Mutual Recognition Agreement (MRA), similar to existing agreements with many third countries, covering batch and import testing by manufacturers and Official Medicines Control Laboratories (OMCLs) as well as GMP inspections, based on global Good Manufacturing Practice standards, as well as CE-marking of medical devices and technologies.

Parliamentary Coverage

Political leadership and flexibility essential if deal with the EU is to be reached, says Committee

The Committee on the Future Relationship with the European Union, 19 June 2020

A cross-party report, agreed unanimously by the Committee on the Future Relationship with the European Union, examines the effect of the Covid-19 pandemic on the negotiations, and outlines what needs to change if a deal is to be agreed before the end of the transition period on 31 December. It also considers the preparations and Government assistance required to ensure that UK businesses are ready for the changes coming from 1 January 2021, whether or not there is a deal.

Key recommendations include:

  • Intensified face-to-face negotiations are needed to make progress
  • Political leadership is required if the deadlock is to be broken
  • More detail must be provided on the checks that will be required on GB-NI to trade under the Northern Ireland Protocol
  • New border arrangements need to work for all concerned
  • The Government must prepare for the possibility of no agreement being reached

House of Commons – Amendments Tabled, 18 June 2020 – Medicines and Medical Devices Bill
Notices of Amendments as at 17 June 2020 have been published to the Medicines and Medical Devices Bill.

House of Commons, Written Answer – 18 June 2020

Anne Marie Morris (Newton Abbot): To ask the Secretary of State for Health and Social Care, if he take steps to ensure that the public is consulted prior to bringing forward legislative proposals to grant pharmacists the power to amend prescriptions as they see fit in the event of shortages of medicine.

Jo Churchill: Allowing pharmacists to take local action to amend prescriptions without a Serious Shortage Protocol being in place could potentially risk exacerbating shortages by depleting supplies of any alternative medicine provided. The Government is not currently formally pursuing such a proposal in England.

Full Coverage

Trade groups set out pharma priorities to EU Commission President for EU-UK Brexit negotiations

The Pharma Letter, 18 June 2020

The major European pharma trade groups have written to the European Commission president Ursula von der Leyen and other officials, to prioritize health and patients’ access to medicines in the EU-UK Brexit negotiations, and shield them from larger political considerations.

They say they are extremely concerned about the lack of progress with only six months until the end of the Transition Period, which could lead to a failure to reach a negotiated outcome on the future EU-UK relationship. In addition to Brexit, COVID-19 has underlined the importance of global medicine supply chains, and the industry has undertaken a sustained global effort to ensure continued access to medicines for patients throughout the crisis.

Signed, among others, by European Federation of Pharmaceutical industries and Associations (EFPIA) director general Nathalie Moll, and Adrian Van den Hoven, director general of Medicines for Europe, the letter says:

First, it is crucial to ensure as much cooperation as possible with regard to regulatory processes and the import and export of medicines and medical supplies across UK/EU borders, in order to minimize delays in products reaching patients.

They say this could be easily achieved with a Mutual Recognition Agreement (MRA), similar to existing agreements with many third countries, covering batch and import testing by manufacturers and Official Medicines Control Laboratories (OMCLs) as well as GMP inspections, based on global Good Manufacturing Practice standards, as well as CE-marking of medical devices and technologies.

Could be negotiated outside of the political trade talks

Such an MRA and fruitful regulatory cooperation are of fundamental importance to patients on both sides and could also be negotiated outside of the political trade talks, in a close dialogue between the respective regulatory authorities. For instance, this was the case during the Transatlantic Trade and Investment Partnership (TTIP) negotiations between the European Union and the USA. The two regulatory bodies, the US Food and Drug Administration and the European Medicines Agency, engaged in a direct dialogue and closed the MRA outside of the TTIP negotiations that were never concluded.

Second, it is also important to ensure simplified and rational rules of origin, based on common, defined chemical, pharmaceutical and biotechnology processing activities, and smooth import clearance processes to avoid any disruption in the delivery of sensitive goods.

“The pharmaceutical and biotechnology industries are doing everything in their power to prepare for all scenarios and need the support of the European Union to ensure that we can fulfil our promise to the patients who we serve. In such challenging times, and in view of the upcoming negotiating rounds, we hope that you are able to eliminate additional complexities and favor cooperation and close dialogue, based on international definitions,” the letter concludes.

Media and Political Bulletin – 19 June 2020

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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