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MHRA loses EMA contracts in wake of Brexit

The EMA has awarded Britain’s regulatory body the MHRA just two contracts this year, as the European agency suggested that the uncertainty surrounding Brexit has made Britain off limits for new regulatory contracts.

Despite having bid for 36 different contracts this year, the MHRA were only awarded two, both of which were for drugs in which evaluation had already begun. In contrast, in both 2015 and 2016, the MHRA was awarded 22 separate contracts. During this period the UK lead Europe in regards to the number of contracts it received from the European regulator.

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Eight months of 2018 down - where has the year gone? As we move from August into September, and a new issue of Pharmafocus becomes available, it's been a eclectic week for news in the industry - from Novartis' announcement that it will be expanding operations in the wake of the European approval of its CAR T therapy Kymriah, to the release of the UK Government's less-than-reassuring "no deal" Brexit guidance.

Government publishes no-deal Brexit guidance, health secretary tells pharma companies to stockpile medicines

The British Government has published a document offering guidance as to what should be expected in the case of a no-deal Brexit.  

The document notes that “If there’s no deal, the UK’s participation in the European regulatory network would cease”. Equally the UK would immediately leave the EU in March 2019 without a transition period. In crashing out of the European Union the UK’s pharmaceutical industry would likely experience significant disruption.

Brexit Health Alliance calls for effective planning for no-deal Brexit

Image Credit: Duncan Hall

Niall Dickson, co-chair of the Brexit Health Alliance has called for immediate comprehensive and effective plans for a no deal Brexit.

Dickson said in a statement that “The NHS, the healthcare and pharmaceutical industries and the entire medical research community remain deeply concerned about the risks to patients, should there be no-deal. It ought to be possible to manage those risks but we do need effective planning and comprehensive guidance, and we need this now.

Leaked letter warns of NHS disruption after Brexit

NHS Providers, the membership organisation and trade association for professionals working in the NHS, has warned that the NHS is unprepared for Brexit in a letter leaked to The Times newspaper.

Ministers and health service bosses were accused of having failed to adequately prepare for a no-deal Brexit as the letter warned that a hard Brexit could disrupt supply chains and leave Britain vulnerable to infectious diseases.

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There was some clarity on Brexit this week as the MHRA set out a plan for the implantation period set to begin in March 2019. However the murky depths of the pharma industry came to the surface as US congressman Chris Collins was arrested for insider trading while a court case opened by the families of veterans alleged that pharma giants had funded terror in Iraq. 

Meanwhile England’s most senior GP resigned over inflammatory online comments while Allergan filed legal action against Pfizer over the opioid crisis.

ABPI Chief warns of Brexit impact on EU

Image Credit: Håkan Dahlström

The head of the Association of the British Pharmaceutical Industry (ABPI) has warned that European governments have failed to recognise the impact a no-deal Brexit would have on medical supply chains between Europe and the UK.

Mike Thompson, Chief Executive of the ABPI told The Pharmaceutical Journal that a no-deal Brexit could significantly disrupt the movement of the 45 million packs of medicine that travel from the UK into the EU each month as well as the 37 million packs of medicine imported from the EU into the UK.

MHRA sets out Brexit implementation period plan

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have released an update which sets out what pharmaceutical and healthcare companies should expect from the Brexit implementation period that will run from March 2019 to December 2020.

Before the implementation period, the UK will remain a full member of the European Union. This will mean that the UK will retain all of the rights and obligations associated with EU membership.

Pfizer to consider stockpiling medicines in preperation for no-deal Brexit

Pfizer is considering joining AstraZeneca, Sanofi and MSD in stockpiling medicines in preparation for a hard Brexit, it has emerged.

The revelation comes as International Trade Secretary Liam Fox suggested that a hard Brexit would be the most likely outcome of current Brexit negotiations.

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While average temperatures dropped to a comfortable 22 degrees, the past week has put the EMA in a sticky position as their landlord served them a £500 million bill for unpaid rent.

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