In this week’s news, UK Government seeks bigger ‘no-deal’ stockpiles, AZ changes contractor at HQ, regs stifling pharma innovation says expert and more…
UK Government asks pharma for bigger drug stockpiles
The UK Government has asked drug firms to stockpile an additional 6 weeks of drug supplies in the event it fails to secure a trade agreement with the EU.
Matt Hancock, health and social care minister, made the request last week, warning additional supplies of some vital medicines – such as vaccines and radioisotopes – will be needed to if the Tory Government pulls the UK out of the EU without a deal.
“Without a deal, the supply chains for these products may be affected by changes to border processes and procedures. To address this issue the Department is working with the relevant pharmaceutical companies to ensure that UK stockpiles of medicines are adequate to cope with any potential delays at the border that may arise in the short term.”
He added, “We are therefore asking pharmaceutical companies that supply medicines for NHS patients from, or via, the European Union or EEA, to ensure they have a minimum of six weeks additional supply in the UK, over and above their business as usual operational buffer stocks, by 29th March 2019.”
In response Steve Bates, chief executive of the UK Bioindustry Association, said delivering a six week supply before March 29 will be “a massive challenge” and called on all parties to try and prevent a no-deal Brexit.
UK to accept drugs tested and released in EU
Hancock also confirmed that – in the event of a no-deal Brexit – the UK will continue to accept products that have been batch tested and released in accordance with EU rules.
In practice this means there will be no need for any further manufacturer led batch testing and release of medicines in the UK.
Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, was more positive about the Government’s willingness to accept drugs batch released in the EU.
“By agreeing to recognise and use medicines and vaccines licensed and manufactured in the EU, the UK Government has taken an important step to protect patients. We urge the EU Commission to do the same.
“We need to be clear that a ‘no deal’ scenario is not in the interest of patients. Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety.”
Delays to AstraZeneca’s move into new HQ
Anglo-Swedish drug firm AstraZeneca has confirmed relocation to the HQ it is building in Cambridge, UK will be delayed.
An AZ spokesperson told endpoints last week “as the scientific fit-out and commissioning phase of the building takes shape, we are transitioning from Skanska to a company called Mace which has expertise in this next phase…as of now, we’re looking at occupation in the first half of 2020.”
Originally, the project was supposed to be completed in 2016.
Demand for biologics CMOs increasing says report
The contracting sector will see more demand for biologics-focused contract development and manufacturing services according to the authors of a new study.
Future Market Insights released the report last week.
The authors citied a number of important growth drivers including a surge in biologic approvals in major markets, patent loss for older products and the increasing prevalence of cancer.
Regulations are restricting drug industry innovation says expert
The complex rules that govern the production and sale of medicines is holding back innovation according to Girish Malhotra, President of EPCOT International.
Writing in the CPhI WW annual report, Malhotra said “For manufacturing technology innovations to be successful, pharma companies need to have an economic and commercial incentive. It is this incentive that drives forward innovation and advancement.
“But the regulators – in particular the [US] FDA – are still dictating approaches to industry without asking what the commercial justifications are to support them.”
He went on to suggest that measures to shorten approval timelines would incentivize developers and “let market forces drive process innovation.”
The viewpoint is one of a range included in the report. Read more at HealthcareDive.
Also in the news
PharmaTech wrote about the likely changes a no-deal Brexit would impose on both UK drug firms and those that supply the market.