News

Media And Political Bulletin – 20 November 2018

Media and Political Bulletin

20 November 2018

Media Summary

British drugmakers push fresh critique of post-Brexit plan

Politico, Helen Collis, 19 November 2018

Politico reports that Britain’s drugmakers have hardened their stance against what they say is a lack of detail on how patients will be protected in plans for the EU and U.K.’s future relationship after Brexit.

The Association of the British Pharmaceutical Industry and the U.K. BioIndustry Association set out a wishlist for what should be included in the so-called political declaration, a framework for talks on the relationship after the Brexit transition period.

The industry groups say the plan needs more details on many areas affecting the pharmaceutical industry, including preventing fake medicines from entering the market, sharing data to flag side-effects on drugs under pharmacovigilance, and ensuring the safety and supply of almost 1 billion packets of medicines traded between the U.K. and EU27.

Pharma leaders warn Brexit deal lacks detail needed for patient safety

Financial Times, Sarah Neville, 19 November 2018

This article is subject to a Copyright Policy, but can be viewed online.

British pharma group praises draft Brexit agreement, but has concerns about drug safety

MedCity News, Alaric Dearment, 19 November 2018

MedCity News reports that while a draft agreement for the UK’s withdrawal from the European Union led several key British officials to resign, one provision of it drew praise from the UK’s drug industry. However, the group also expressed concerns about a separate, but related draft political declaration.

The ABPI noted Monday that while the draft political declaration refers to “cooperation on matters of health security,” it does clarify how it will protect patients with respect to medicines safety, public health disasters and infectious disease control. These include preventing fake or fraudulent drugs from entering the supply chain; sharing data between EU countries that flag potential problems with drugs; ensuring that the packets of medicines traveling between the UK and the rest of Europe – nearly 1 billion – are safe; and preventing and controlling infectious diseases.

Health sector coalition urges Government to safeguard patients in future UK-EU relationship

News Medical, no author, 19 November 2018

News Medical reports that a coalition from the UK’s health sector say Brexit negotiators have a responsibility to protect 500 million patients on both sides of the Channel. The group is calling on both sides to make patients and public health central to the Political Declaration for the future relationship between the UK and the EU.

The current draft Political Declaration includes references to ‘cooperation on matters of ‘health security’. However, it does not make it clear how it will guarantee that patients are protected as they are today on issues including medicines safety, public health disasters and infectious disease control.

Pharmacists need not dispense European prescriptions after no-deal Brexit, says General Pharmaceutical Council

Pharmaceutical Journal, Carolyn Wickware, 19 November 2018

Pharmaceutical Journal reports that the General Pharmaceutical Council (GPhC) has said that pharmacists need not dispense prescriptions issued in another European country in the event of a ‘no-deal’ Brexit.

In its response to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on Brexit contingency plans, submitted in 1 November 2018, the GPhC said it did not agree with the MHRA’s proposal “to enable continued recognition of prescriptions issued in an EU/EEA [European Economic Area] country”.

Instead, the GPhC argued that recognising prescriptions from the EEA could put patient safety at risk as the practitioners writing the prescriptions may no longer be qualified to do so in the UK after a no-deal Brexit.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

British drugmakers push fresh critique of post-Brexit plan

Politico, Helen Collis, 19 November 2018

Britain’s drugmakers today hardened their stance against what they say is a lack of detail on how patients will be protected in plans for the EU and U.K.’s future relationship after Brexit.

The Association of the British Pharmaceutical Industry and the U.K. BioIndustry Association set out a wishlist for what should be included in the so-called political declaration, a framework for talks on the relationship after the Brexit transition period.

While the U.K. and EU already published a seven-page outline, Prime Minister Theresa May said Saturday this part of the Brexit deal is still up for negotiation.

The industry groups say the plan needs more details on many areas affecting the pharmaceutical industry, including preventing fake medicines from entering the market, sharing data to flag side-effects on drugs under pharmacovigilance, and ensuring the safety and supply of almost 1 billion packets of medicines traded between the U.K. and EU27.

“Brexit negotiators have an opportunity to take decisions today which will protect patients in the future,” the ABPI’s Chief Executive Mike Thompson said, adding that, “while there are positives in the political declaration, the detail is missing.”

Steve Bates, Chief Executive of the BIA, said the draft declaration “has missed an opportunity to prioritise patients across Europe and the U.K.”

POLITICO last week reported that groups within the life sciences and health sectors weren’t sold on the deal.

Initial statements from ABPI and the BIA on Thursday welcomed the clarity provided by the separate 585-page Withdrawal agreement covering the Brexit transition period.

Pharma leaders warn Brexit deal lacks detail needed for patient safety

Financial Times, Sarah Neville, 19 November 2018

This article is subject to a Copyright Policy, but can be viewed online.

British pharma group praises draft Brexit agreement, but has concerns about drug safety

MedCity News, Alaric Dearment, 19 November 2018

The UK would remain subject to EMA regulations during a “transition period” to minimize drug supply disruptions, drawing industry praise. But a trade group was also concerned that a draft political declaration could jeopardize drug safety.

While a draft agreement for the UK’s withdrawal from the European Union led several key British officials to resign, one provision of it also drew praise from the UK’s drug industry. However, the group also expressed concerns about a separate, but related draft political declaration.

The 585-page draft agreement around Brexit, released last Wednesday, provides for a “transition period” that the UK and the EU agreed to earlier this year, which would last from the date of Brexit – March 29, 2019 – until Dec. 31, 2020. The Guardian reported that could also be extended to the end of 2022. During the transition period, the UK will continue to follow EU rules and regulations while the two parties finalize their trade relationship. The draft agreement will be up for a vote in the House of Commons in December.

In a statement Thursday, the Association of the British Pharmaceutical Industry said it welcomed the agreement for a transition period, which would prevent a disruption in the drug supply during that time. “Agreeing to a transition period will mean that our members can continue to supply medicines to patients without delay or disruption come March 2019,” ABPI CEO Mike Thompson said in a statement.

But a related draft political declaration on the relationship between the UK and EU, also released Wednesday, drew concern from the group.

The ABPI noted Monday that while the draft political declaration refers to “cooperation on matters of health security,” it does clarify how it will protect patients with respect to medicines safety, public health disasters and infectious disease control. These include preventing fake or fraudulent drugs from entering the supply chain; sharing data between EU countries that flag potential problems with drugs; ensuring that the packets of medicines traveling between the UK and the rest of Europe – nearly 1 billion – are safe; and preventing and controlling infectious diseases. The group urged the two parties to include in the text specific reference to the importance of cooperating on drug regulations, as well as on science and innovation, and protecting people from counterfeit drugs and infectious diseases.

The document states that the respective drug regulators in the EU and UK – the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency – must provide each other with marketing authorization dossiers for products they have approved before the end of the transition period. The EMA regulates drugs for the EU and also for the non-EU European Economic Area countries of Norway, Iceland and Liechtenstein. Switzerland has an independent regulatory agency, Swissmedic. The EMA, currently headquartered in London, will move to Amsterdam.

The agreement was nevertheless controversial and led to the resignation of Brexit Secretary Dominic Raab. In a letter to Prime Minister Theresa May, he wrote that “the regulatory regime proposed for Northern Ireland presents a very real threat to the integrity of the United Kingdom.” In addition, he objected to a “backstop” provision whereby the EU could effectively veto UK’s ability to withdraw. Steve Barclay, a junior minister in the Department for Health, was promoted to replace him. Other resignations included Suella Braverman, a junior minister for Brexit; Work and Pensions Secretary Esther McVey; and Northern Ireland junior minister Shailesh Vara.

Health sector coalition urges Government to safeguard patients in future UK-EU relationship

News Medical, no author, 19 November 2018

A coalition from the UK’s health sector say Brexit negotiators have a responsibility to protect 500 million patients on both sides of the Channel. The group is calling on both sides to make patients and public health central to the Political Declaration for the future relationship between the UK and the EU.

The current draft Political Declaration includes references to ‘cooperation on matters of ‘health security’. However, it does not make it clear how it will guarantee that patients are protected as they are today on issues including medicines safety, public health disasters and infectious disease control.

The coalition say that current systems which align the UK and the EU in the interest of patient safety are in jeopardy, including:

  • Preventing fake or fraudulent medicines from entering the legal supply chain
  • Sharing data and ‘signals’ between EU countries that flag potential problems with medicines
  • Preventing and controlling infectious diseases across Europe, as billions of people travel between ports and airports
  • Ensuring the safety and supply of almost 1 billion packets of medicines between the UK and Europe every year

So that patients can continue to benefit from this cooperation, the organizations are calling for the following to be included in the text of the final Political Declaration on the future UK-EU relationship:

  • To make specific reference to the importance of cooperating on the regulation of medicines.
  • To make clear that the UK and EU will cooperate on protecting citizens from infectious disease and counterfeit medicines.
  • To make clear that the UK and EU will agree closer collaboration on science and innovation

ABPI Chief Executive Mike Thompson said: “Brexit negotiators have an opportunity to take decisions today which will protect patients in the future. While there are positives in the political declaration, the detail is missing.  We are asking Government to give explicit commitments on issues of public health and medicines safety which we think is the minimum that patients across Europe should expect.”

BIA CEO, Steve Bates, said: “The draft Political Declaration has missed an opportunity to prioritize patients across Europe and the UK.  It is vital that patients are included in the next Political Declaration and are a priority for discussions to ensure public health and patient safety are not negatively affected by Brexit – both day 1 post-Brexit and in the future.”

Niall Dickson, chief executive of the NHS Confederation, which represents organizations across the healthcare sector, said: “We understand that there is still much detail to be worked out on the future relationship between the UK and the EU, and we are pleased that the withdrawal agreement preserves key safeguards for patients during the implementation period.

But we need assurances from the UK and the EU authorities that they will put patients first as they negotiate details of the long-term relationship.

That means putting some specific but non-controversial commitments in the political declaration which make clear that surveillance systems which protect patients will be retained, that we will continue to collaborate on public health to control epidemics and manage infectious diseases, and that we align the regulation of medicines and medical devices.

These ambitions were reflected in the UK Government’s White Paper on the UK-EU future relationship and are consistent with the commitment made in the draft political declaration to maintain co-operation on health security, but they need to be spelt out.”

Pharmacists need not dispense European prescriptions after no-deal Brexit, says General Pharmaceutical Council

Pharmaceutical Journal, Carolyn Wickware, 19 November 2018

Recognising prescriptions from the EEA could put patient safety at risk, pharmacy regulator claims.

Pharmacists need not dispense prescriptions issued in another European country in the event of a ‘no-deal’ Brexit, the General Pharmaceutical Council (GPhC) has said.

In its response to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on Brexit contingency plans, submitted in 1 November 2018, the GPhC said it did not agree with the MHRA’s proposal “to enable continued recognition of prescriptions issued in an EU/EEA [European Economic Area] country”.

Instead, the GPhC argued that recognising prescriptions from the EEA could put patient safety at risk as the practitioners writing the prescriptions may no longer be qualified to do so in the UK after a no-deal Brexit.

Under current legislation, EU prescriptions can be dispensed in the UK under the EU cross-border healthcare directive.

The GPhC’s consultation response said: “It is anticipated that this directive will cease to apply to the UK in the case of no deal.

“In view of this we do not agree that provision needs to be made to continue the recognition of EEA prescriptions.”

It added that a no-deal Brexit could end the mutual recognition of medical qualifications between EEA countries, and the GPhC said further legislation “should not be drafted to permit the continued recognition of EEA prescriptions for dispensing here if the EEA qualified prescribers themselves would no longer be recognised as meeting the professional qualification requirements for registration in the UK”.

The consultation response also warned that online prescribing services “have developed because of the legislative provisions on recognition of electronic EEA prescriptions” despite falling “outside the UK regulatory remit of the General Medical Council, Care Quality Commission and the other devolved regulators”.

The GPhC response said: “Continuing the recognition of electronic EEA prescriptions when the cross-border healthcare directive no longer applies fails to ensure patient safety in the digital healthcare environment and poses significant risks to patient safety.”

However, the regulator clarified that in an emergency and “in the absence of a prescription”, pharmacists should continue to be able to “supply a patient with medicinal products if the pharmacist is satisfied that the medicinal products had been previously prescribed for the patient by a ‘relevant prescriber’”.

It said: “In these limited situations the definition of ‘a relevant prescriber’ would need to include an EEA health professional.”

A spokesperson for the National Pharmacy Association disagreed with the GPhC, saying they “agree with the MHRA proposal to enable continued recognition of prescriptions issued in an EU country”.

They added: ”However, concerns that arise with the dispensing of prescriptions such as the different legal requirements, the validity of the prescriber, and the need to identify what the generic and/or UK brand is, need to be addressed first.”

The GPhC was unable to comment on whether UK prescriptions would be recognised in EU countries after a no-deal Brexit.

Media And Political Bulletin – 20 November 2018

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