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Media And Political Bulletin – 6 November 2018

Media and Political Bulletin

6 November 2018

Media Summary

No-deal Brexit presents risk for EU patients as well as UK, manufacturers’ representatives say

The Pharmaceutical Journal, Corrinne Burns, 5 November 2018

The Pharmaceutical Journal reported that representatives from the UK pharmaceutical and biotechnology industry have warned that leaving the EU without a deal would increase the risk of counterfeit medicines entering both the UK and EU supply chain.

In a joint response to the MHRA’s consultation on contingency plans for the regulation of medicines and medical devices in case of a no-deal Brexit, the Association of the British Pharmaceutical Industry (ABPI) and the UK Bioindustry Association (BIA) said the MHRA’s proposals would put patients in the EU at risk.

Brexit talks: DHSC asks drug companies to sign gag clause

Pharmacy Business, Kiran Paul, 5 November 2018

Pharmacy Business reported that reports revealed the Department for Health and Social Care (DHSC) is asking drug companies and industry bodies to sign non-disclosure agreements (NDAs) before Brexit related discussions.

Government earlier asked drug companies to stockpile an additional six weeks’ worth of medicines to offset the danger of significant shortages in the event of a no-deal Brexit scenario.

October supply issues update

Dispensing Doctors’ Association, Ailsa Colquhoun, 5 November 2018

The Dispensing Doctors’ Association reported that the Department of Health and Social Care has published its October medicines supply issues update.

Their update details the following shortages: Epilim 250mg chromosphere; Fragmin (dalteparin) 2,500units/ 5,000units and 7,500units (Pfizer); Stemetil (prochloperazine) 5mg in 5ml oral syrup; Salofalk (mesalazine) 500mg suppositories (Dr. Falk Pharma).

Parliamentary Coverage

There was no parliamentary coverage today. 

Full Coverage

No-deal Brexit presents risk for EU patients as well as UK, manufacturers’ representatives say

The Pharmaceutical Journal, Corrinne Burns, 5 November 2018

Representatives from the UK pharmaceutical and biotechnology industry have warned that leaving the EU without a deal would increase the risk of counterfeit medicines entering both the UK and EU supply chain.

Proposals for a no-deal Brexit put forward by the Medicines and Healthcare products Regulatory Agency (MHRA) would put patients in the EU at risk, the Association of the British Pharmaceutical Industry (ABPI) and the UK Bioindustry Association (BIA) have said.

In a joint response to the MHRA’s consultation on contingency plans for the regulation of medicines and medical devices in case of a no-deal Brexit, published on 1 November 2018 to coincide with the closing of the consultation, the two bodies also warned that the plans could increase the risk of falsified medicines entering the UK.

A no-deal Brexit is likely to see the UK’s access to EU databases revoked — including the European Medicines Verification System (EMVS), the heart of EU-wide compliance to the Falsified Medicines Directive (FMD).

The EMVS is a central EU database that will store details of FMD-compliant medicine packs. If access is revoked under no-deal terms, UK pharmacists and suppliers will be unable to decommission medicines when they are dispensed.

The MHRA has therefore proposed that the legal requirement to decommission medicines would be removed in the UK, along with the requirement to verify the authenticity of packs. But the ABPI and BIA warn that this would “introduce a security risk to all other national systems”: if a pack is not decommissioned, the EMVS will be unaware that it has been dispensed, and its details could be duplicated on a falsified pack.

The proposals present a risk to UK patients too, as unilaterally revoking FMD legislation in the UK would make the country a target for counterfeiters, the two bodies say.

The ABPI and BIA also warn that the UK’s national medicines verification database may become “entirely redundant” if implementation of FMD ‘safety features’ legislation is revoked in the UK. In such a scenario, they say, financial compensation should be given to marketing authorisation holders, manufacturers and other stakeholders for the “significant time and investment” they have already contributed to the system.

Brexit talks: DHSC asks drug companies to sign gag clause

Pharmacy Business, Kiran Paul, 5 November 2018

The Department for Health and Social Care (DHSC) is asking drug companies and industry bodies to sign non-disclosure agreements (NDAs) before Brexit related discussions, reports revealed.

The gag clause demands representatives who take part in the discussions with the department “not to divulge the subject or contents of any meeting, not to share or in any way disseminate any information provided by the department [and] not to take or make a copy of any papers provided for a meeting,” the Times reported quoting a draft agreement prepared by the DHSC.

The DHSC is engaged in talks with the stakeholders on contingency plans to ensure supply of medicines in the event of a no-deal Brexit.

The discussions will divulge “confidential and sensitive information about customs and border arrangements and supply routes with the company,” claims the four-page, 900-word agreement.

Politico reported, citing the same agreement, that information is being provided orally, or via hard copies of documents that must be returned at the end of meetings.

Government has earlier asked drug companies to stockpile an additional six weeks’ worth of medicines to offset the danger of significant shortages in the event of a no-deal Brexit scenario.

Community pharmacists, however, have been instructed not to stock more medicines.

October supply issues update

Dispensing Doctors’ Association, Ailsa Colquhoun, 5 November 2018

The Department of Health and Social Care has published its October medicines supply issues update. This details the following shortages:

Epilim 250mg chromosphere: no stock available until the end of November. Stock levels of 100mg and 500mg Epilim Chronosphere are sufficient only for normal market demand. Alternatives include: Epilim Liquid and Epilim Syrup, and other sodium valproate preparations.

Fragmin (dalteparin) 2,500units/ 5,000units and 7,500units (Pfizer).

  • 2,500units presentation – out of stock with a resupply date of w/c 12 November.
  • 5,000 units presentation – likely to go out of stock during w/c 31 October with a resupply date of w/c 12 November.
  • 7,500units presentation –  out of stock with a resupply date of w/c 12 November.
  • Alternative LMWH suppliers are available.

Stemetil (prochloperazine) 5mg in 5ml oral syrup: very limited stock available until approximately late November 2018 with next delivery not due until the middle of 2019.

Salofalk (mesalazine) 500mg suppositories (Dr. Falk Pharma).

  • Supplies are currently limited and there is likely to be a two-week gap in supply until the next delivery of stock in late November.
  • A very small amount of stock will be reserved for emergency orders.
  • Salofalk 1g suppositories will remain available.

The letter also details ongoing and resolved issues, and discontinuations.

Media And Political Bulletin – 6 November 2018

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