News

Media And Political Bulletin – 04 September 2018

Media and Political Bulletin

04 September 2018

Media Summary

ABPI backs community pharmacy’s absence from Brexit stockpiling

The Pharmaceutical Journal, Kathy Oxtoby, 3 September 2018   

The Pharmaceutical Journal reports that Mike Thompson, the Chief Executive of the Association of the British Pharmaceutical Industry, said that individual pharmacies not stockpiling drugs was ‘clearly best practice from a logistics point of view.’

The article also states that Mike Thompson described the effort to build up a buffer of medicines in case of ‘no-deal’ Brexit as “the biggest logistical challenge the industry has faced in peace time”.

Thompson also stated that the ABPI had been recommending to pharma companies that they should be preparing for a no-deal Brexit from “as early as last year”.

EMA freezes UK representatives out of drug reviews as Brexit looms

Pharmaphorum. Richard Staines, 3 September 2018

Pharmaphorum reports on the fact that the UK’s drugs regulator is increasingly being frozen out of work with the European Medicines Agency, dealing a blow to the government’s hopes that it could play a leading role in European drug reviews after Brexit.

The article highlights the fact that in 2016 the EMA appointed 22 rapporteurs to review new medicines, but in 2017 it appointed just six, citing Mike Thompson, Chief Executive of the ABPI, who said that the process is like the end of a ‘British success story.’

Thompson added that this is ‘hundreds of millions of pounds’ that could be spent on researching new medicines, but the industry has ‘no choice’ as it has to comply with regulations.

Safeguarding the availability of medicines in the EU

Health Europa, 3 September 2018

Health Europa reports that an EU-wide task force, which was set up by the EMA and the heads of medicines agencies, has set out a series of necessary actions to ensure the availability of medicines in the EU in a newly published work programme for 2019 / 20.

The task force is committed to identifying, managing and communicating on issues that can affect the availability of medicines in the EU, its main aim being to improve the continuity of supply of human and veterinary medicines across Europe.

The task force additionally provides a useful forum to facilitate and co-ordinate actions between Member States, the European Medicines Agency (EMA) and the European Commission in the context of Brexit, which is also expected to impact on the availability of medicines in the EU.

Pfizer Estimates Brexit Costs at $100 Million as Talks Drag On

Bloomberg, James Paton, 4 September 2018

This Bloomberg report highlights the fact that European companies are ‘not alone in their Brexit pain.’ Pfizer has said that its costs for dealing with the upcoming split ‘will reach $100 million.’

Pfizer said in an email that its costs stem from transferring product testing and licenses to other countries, changing clinical trial management procedures, and other preventive measures.

The article also states that pharma companies around the world have long relied on their ability to move people and goods in and out of countries, and Britain’s departure from the EU could complicate many aspects of their operations. The U.K. Department of Health and Social Care last month told drug makers to build six-week stockpiles of their products in preparation for potential shipping delays.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

ABPI backs community pharmacy’s absence from Brexit stockpiling

The Pharmaceutical Journal, Kathy Oxtoby, 3 September 2018  

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, said that individual pharmacies not stockpiling drugs was “clearly best practice from a logistics point of view”.

The head of the Association of the British Pharmaceutical Industry (ABPI) has backed a decision not to involve community pharmacy in Brexit stockpiling of drugs.

Mike Thompson described the effort to build up a buffer of medicines in case of ‘no-deal’ Brexit as “the biggest logistical challenge the industry has faced in peace time”.

In a letter dated August 2018, Matt Hancock, secretary of state for health and social care, warned pharmacists and GPs not to stockpile drugs. In his letter, he said the government was instead working with pharmaceutical manufacturers to secure six weeks’ worth of medicine stocks for when the UK leaves the EU in March 2019.

Thompson told The Pharmaceutical Journal that he thought it was a “sensible decision” from government that community pharmacists have been told not to stockpile medicines.

He described it as “clearly best practice from a logistics point of view”, adding that it would mean pharmacy would receive medicines “at the point they have a prescription” rather than “second guessing by stockholding themselves”.

Thompson said the ABPI had been recommending to pharma companies that they should be preparing for a no-deal Brexit from “as early as last year”.

He said that while companies already carry buffer stocks to ensure medicines get to patients, what they have not known is how much extra stock they should prepare for any delays at the UK’s border.

“What the government has done is provide guidance on how much additional stock companies should carry to cover that eventuality,” he said.

“We’ve clarified with the Department of Health and Social Care (DHSC) that this is not a blanket six weeks’ extra stock for everybody. Companies need to look at their own buffer stocks and assess whether they have enough stocks to cover a six week delay at the border, and adjust their buffer stocks accordingly.

“This is not just about building stocks for one particular product but asking the industry to build stocks across everything — so the scale of what’s being asked by the government increases the risk particularly for generic companies and smaller companies.”

He said the cost of working capital “will run to hundreds of millions of pounds” and that the ABPI would like to see the government providing “a small amount of money to help cover costs of additional warehousing”.

Thompson said the ABPI was working in partnership with wholesalers and pre-wholesalers through a committee set up by DHSC, so “people can have confidence that this is a robust plan put in place to manage this situation”.

The industry will also be looking at additional safeguards to protect the medicines supply in the UK in the longer term after Brexit, such as moving them by airplane, he said.

EMA freezes UK representatives out of drug reviews as Brexit looms

Pharmaphorum. Richard Staines, 3 September 2018

The UK’s drugs regulator is increasingly being frozen out of work with the European Medicines Agency (EMA) according to a press report, dealing a blow to the government’s hopes that it could play a leading role in European drug reviews after Brexit.

With Brexit talks progressing at a snail’s pace and the deadline of March 29th looming, the EMA has been preparing for a “no-deal” situation where the UK becomes a third country and plays no part in the European drugs regulation system.

And the latest report casts doubts about the prime minister’s plans for the UK to continue with its involvement with the EMA after Brexit.

The Guardian reported that the EMA has ceased to appoint experts from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to oversee centralised reviews of more complex medicines.

These so-called rapporteurs, who can be appointed from any EU country, follow the progress of a medicine as it goes through the EMA’s committee process.

And until the Brexit vote in 2016 the UK played a leading role in this process, providing more rapporteurs than any other country.

But the EMA said that as the Brexit deadline approaches, and with the MHRA looking set to cut its ties with Europe along with the UK and the rest of its agencies, it cannot be confident that MHRA staff will be able to follow the entire review process for recently filed drugs.

EMA reviews usually take around a year, meaning that any drugs that are filed now will still be in the middle of their review when Brexit happens in March.

Rapporteur work being carried out by the MHRA is also being reallocated to representatives from other EU countries.

Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, told the Guardian that the changes are a “disaster” for the UK’s MHRA, which earns around £14 million from the EMA.

In 2016 the EMA appointed 22 rapporteurs to review new medicines, but in 2017 it appointed just six.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said the process is like the end of a “British success story”.

Pharma companies are already having to build extra labs to batch release medicines made in the UK on the continent.

Thompson added that this is “hundreds of millions of pounds” that could be spent on researching new medicines, but the industry has “no choice” as it has to comply with regulations.

The EMA is in the process of moving around 900 staff from its London offices, to Amsterdam, which will be its new home after Brexit.

The MHRA said in a statement: “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices. This involves us making sure our regulators continue to work together, as they do with regulators internationally and we would like to explore with the EU the terms on which the UK could continue to participate in the EMA.”

Some elements of the MHRA’s role will change during the Implementation Period. For example, for medicines – as with all areas – the UK will no longer have voting rights in the EMA and EU committees, and MHRA will no longer lead assessments on behalf of the EMA to inform their decision-making process.

“We are currently considering the potential impact of different Brexit outcomes on MHRA. It is important to remember the bulk of agency regulatory work is national, as is its income, said the MHRA.”

A spokesperson for the ABPI said: “The strength of the MHRA has been key to the overall strength of the European regulatory system.”

“The ABPI has been clear that we want to see as close cooperation as possible between the MHRA and the EMA.  As we enter the final stages of the Brexit negotiations, we are looking for politicians to make this central to the future UK-EU relationship.”

“Continued cooperation in the long standing systems to protect patient health, control infectious diseases and manage medicine safety is in the best interests of patients in the UK and the EU.”

Safeguarding the availability of medicines in the EU

Health Europa, 3 September 2018

In its newly published work programme for 2019/20, an EU-wide task force has set out a series of necessary actions to ensure the availability of medicines in the EU.

The task force is committed to identifying, managing and communicating on issues that can affect the availability of medicines in the EU, its main aim being to improve the continuity of supply of human and veterinary medicines across Europe.

The task force additionally provides a useful forum to facilitate and co-ordinate actions between Member States, the European Medicines Agency (EMA) and the European Commission in the context of Brexit, which is also expected to impact on the availability of medicines in the EU.

Who is involved in the task force?

It was set up by the EMA and the Heads of Medicines Agencies, and includes representatives from the European Commission and interested national competent authorities.

The chairs of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human and Veterinary, the GMP/GDP Inspectors Working Group, the Working Group of Communication Professionals and the European Surveillance Strategy Working Group are also represented within the task force.

How can availability issues be addressed?

In its 2019/20 work programme, the task force list several actions that both regulators and industry can take to ensure the availability of medicines in the EU.

These include:

  • Investigating ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework
  • Developing strategies to improve the prevention and management of shortages caused by disruptions in the supply chain
  • Encouraging best practices within industry to prevent shortages
  • Improving information sharing and best practice exchange among EU regulatory authorities to better co-ordinate actions across the EU
  • Fostering collaboration with stakeholders and enhancing the communication of supply problems to EU citizens.

These priorities and more will be discussed at a dedicated multistakeholder workshop organised by the task force on 8-9 November.

Pfizer Estimates Brexit Costs at $100 Million as Talks Drag On

Bloomberg, James Paton, 4 September 2018

European companies aren’t alone in their Brexit pain. Pfizer Inc., the U.S.-based drug behemoth, says its costs for dealing with the upcoming split will reach $100 million.

The U.K.’s looming rupture with the EU threatens to slow goods at borders that are now wide open and force companies to duplicate regulatory efforts. Pfizer said in an email that its costs stem from transferring product testing and licenses to other countries, changing clinical trial management procedures, and other preventive measures.

The company is working “to meet EU legal requirements after the U.K. is no longer a member state, especially in the regulatory, manufacturing and supply-chain areas,” according to a filing last month where it cited the cost estimate.

Pfizer — which got about 2 percent of its $53 billion in 2017 revenue from the U.K. — highlights the pharmaceutical industry’s dilemma as it braces for a rocky, no-deal Brexit. Uncertainty about the fallout has forced companies including AstraZeneca Plc, GlaxoSmithKline Plc and U.S.-based Merck & Co. to prepare for a worst-case scenario. Hundreds of millions of pounds are being spent on getting ready that could have gone to developing new treatments, the head of an industry trade group said in June.

People and Products

Pharma companies around the world have long relied on their ability to move people and goods in and out of countries, and Britain’s departure from the EU could complicate many aspects of their operations. The U.K. Department of Health and Social Care last month told drugmakers to build six-week stockpiles of their products in preparation for potential shipping delays.

Much of the industry had already begun hoarding medicines or investing in new facilities to release drugs. AstraZeneca, which has committed to setting aside a three-month supply of its products, said it can’t raise inventories of one of its cancer drugs because its production facilities are already at full capacity. Brexit also threatens supplies of medical isotopes that are used to diagnose and treat about 1 million people in the U.K. each year, according to an article in the British Medical Journal.

Companies large and small are enumerating expenditures from the divorce. Glaxo has also estimated as much as about $100 million in costs. Dechra Pharmaceuticals Plc, a veterinary drug company based in northwest England, said it may need to spend as much as 2 million pounds ($2.6 million) in the event of a hard Brexit, in part to duplicate testing and move product registrations to the EU to avoid trade barriers.

Controversy continues to swirl around the U.K.’s plans as Prime Minister Theresa May works to hammer out a compromise agreement to leave the EU. Brexit has already cost Britain more than 2 percent of its economic output, according to an analysis by UBS Group AG published Monday.

Thousands of Miles

Health-care companies based thousands of miles from Brexit ground zero have been warning of an impact on their businesses since the 2016 referendum. Johnson & Johnson, McKesson Corp. and Regeneron Pharmaceuticals Inc. are among those in the U.S. that have flagged the risk.

Intercept Pharmaceuticals Inc., the New York-based maker of the Ocaliva treatment for a rare liver disease, cautioned in an Aug. 7 filing that Scotland and Northern Ireland may hold a vote on whether to leave the U.K., and that other countries may follow Britain out of the EU.

“Our ability to continue to conduct our international operations out of the United Kingdom, where the headquarters for our international operations is located, may be materially and adversely affected,” by Brexit, the company said.

Pfizer began to refer to Brexit as part of a challenging global economic environment in filings last year. The company said it’s pushing the U.K. and EU to work out an agreement to keep their regulatory systems coordinated after the separation.

In addition to supply and regulatory concerns, Pfizer said it may have to reorganize management of its clinical trials. Human testing of new drugs and devices conducted in the EU must be sponsored by an entity based in the bloc, and companies would need to establish new representatives in the EU for their studies.

“In order to minimize any potential patient impact we have undertaken work to ensure we can continue to supply in the EU and the U.K. covering all Brexit scenarios,” the company said.

Media And Political Bulletin – 04 September 2018

From Factory to Pharmacy

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