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Media And Political Bulletin – 02 August 2018

Media and Political Bulletin

02 August 2018

Media Summary

EMA prepares to scale back more activities ahead of move

PharmaTimes, George Underwood, 1 August 2018

The PharmaTimes reports that the EMA has said that it will launch the next phase of its business continuity plan on 1 October at the latest. This will involve temporary cuts in activities as the Agency faces higher than expected staff losses ahead of its relocation to Amsterdam.

The article reports that overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.

Therefore, the next phase of the continuity plan involves scaling back or suspending additional activities through to 2018.

More drugmakers build Brexit stockpiles as EU agency faces exodus

Reuters, 1 August 2018

Reuters reports on the fact that yesterday, both Sanofi and Novartis said that they planned to increase stockpiles of medicines in Britain in preparation for potential disruption if the UK crashes out of the European Union without a deal.

The moves by Sanofi and Novartis follow similar action by AstraZeneca (AZN.L), which said last month it would increase stockpiles of drugs that could be affected by Brexit by around 20 percent.

Roche (ROG.S), the world’s biggest maker of cancer medicines, also said it was taking “appropriate action” to review its stock levels in order to protect supplies to patients.

Britain’s largest drugmaker, GlaxoSmithKline (GSK.L), said last week it was taking steps to secure the supply of its medicines and vaccines ahead of the UK’s departure from the EU, without going into details.

Supplies of thousands of medicines are at risk of disruption if Britain leaves the EU without a deal, forcing manufacturers to prepare duplicate product testing and licensing arrangements to ensure their drugs stay on the market.

More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

EMA prepares to scale back more activities ahead of move

PharmaTimes, George Underwood, 1 August 2018

The EMA has said it will launch the next phase of its business continuity plan on 1 October 2018 at the latest, which will involve temporary cuts in activities as the Agency faces higher than expected staff losses for its relocation to Amsterdam.

“Staff who will not relocate to Amsterdam have already started to leave the Agency,” the EMA said in a statement, “and this trend is expected to accelerate. In addition, due to the employment rules in the Netherlands, 135 short-term contract staff will no longer be able to work for EMA.

“Overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.”

The Agency added that it has put in place supporting measures to facilitate the relocation of staff to Amsterdam and additional support is provided by the Dutch government. Other mitigating actions, such as a comprehensive staff recruitment programme, are already underway. However, in the short- to mid-term EMA will have to reprioritise its resources to fully maintain its core activities related to the evaluation and supervision of medicines to the level of quality and within the timelines expected.

The next phase of the continuity plan therefore involves scaling back or suspending additional activities through to 2018.

These activities include:

Collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58; in other areas, such as the harmonisation of global medicine regulation, EMA will only take a reactive role; EMA’s engagement in other global public health issues such as antimicrobial resistance or vaccines will be maintained as long as possible, but reviewed on a case-by-case basis;

Development and revision of guidelines, which will betemporarily limited to those guidelines that address an urgent public/animal health need or are necessary to support and facilitate preparations for Brexit;

Holding of non-product-related working parties, which will be temporarily reduced as a consequence of the scaling back of guideline development or revision;

Programmes and projects, where activities in relation to project governance will be reduced in line with the reduction/suspension of projects;

Organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions;

Clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018; data packages submitted for medicines until the end of July 2018 will be processed and finalised.

The Agency added that detailed plans for the implementation of these measures are currently being developed and will be communicated to stakeholders concerned and the public as soon as they are available.

More drugmakers build Brexit stockpiles as EU agency faces exodus

Reuters, 1 August 2018

Sanofi and Novartis said on Wednesday they planned to increase stockpiles of medicines in Britain in preparation for potential disruption if the UK crashes out of the European Union without a deal.

At the same time the European Medicines Agency, which oversees drug safety across the bloc, warned of bigger than expected staff losses and cuts in some activities as a result of having to move from London to Amsterdam due to Brexit.

Europe’s equivalent of the U.S. Food and Drug Administration now expects to lose around 30 percent of its workforce as it prepares to relocate by March 2019.

The announcements show how the highly regulated pharmaceuticals sector is feeling the impact of Britain’s looming departure from the EU.

The moves by Sanofi and Novartis follow similar action by AstraZeneca (AZN.L), which said last month it would increase stockpiles of drugs that could be affected by Brexit by around 20 percent.

Roche (ROG.S), the world’s biggest maker of cancer medicines, also said it was taking “appropriate action” to review its stock levels in order to protect supplies to patients.

Britain’s largest drugmaker, GlaxoSmithKline (GSK.L), said last week it was taking steps to secure the supply of its medicines and vaccines ahead of the UK’s departure from the EU, without going into details.

Supplies of thousands of medicines are at risk of disruption if Britain leaves the EU without a deal, forcing manufacturers to prepare duplicate product testing and licensing arrangements to ensure their drugs stay on the market.

More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.

Leading drugmakers have long been vocal in their concerns about Brexit and the need for the pharmaceuticals sector to stay within the European regulatory system.

British lawmakers have also called for an agreement that allows the country to have continued participation in the European medicines regulatory framework, but it remains unclear how this will play out in the broader EU negotiations.

Sanofi said it was confident its stockpiling measures would ensure British patients had access to its treatments after Britain leaves the EU, regardless of whether a deal over its future relations with the bloc is in place.

“The uncertainty in the Brexit negotiations means that Sanofi has always been planning for a no deal scenario,” a spokesman with the French drugmaker said in an emailed statement.

“We have made arrangements for additional warehouse capacity in order to stockpile our products in the UK and increase UK-based resources to prepare for any changes to customs or regulatory processes.”

Novartis said it planned to hold increased inventories in Britain across its portfolio of medicines from both Novartis itself and Sandoz, the Swiss company’s generic drugs division.

We have apprised officials and ministers of our preparedness plans and status, including plans to increase our UK inventory holding,” Novartis said.

The European Medicines Agency has warned drugmakers they needed to be ready for a possible hard Brexit in 2019. It has also expressed “serious concerns” over the availability of some 108 medicines that are manufactured exclusively in the UK.

Media And Political Bulletin – 02 August 2018

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