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Media And Political Bulletin – 05 October 2018

Media and Political Bulletin

05 October 2018

Media Summary

ABPI responds to MHRA consultation on ‘no deal’ legislative proposals

ABPI, Press Release, 4 October 2018

The ABPI has responded to the MHRA’s open consultation on how its legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period.

The ABPI said that it would ‘study the proposals in detail and then submit a response.’ The ABPI’s Deputy Chief Scientific Officer Dr Sheuli Porkess said:

‘It is important that the UK puts plans in place for a ‘no deal’ Brexit. Pharmaceutical companies continue to plan for all possible outcomes from the negotiations and we will continue to work closely with the Government on their plans.’

Drugs regulator warns on no-deal Brexit access to new medicines

Financial Times, Sarah Neville, 4 October 2018

The Financial Times reports on the MHRA’s consultation highlighting the fact that the drugs regulator has warned that a no-deal Brexit would threaten Briton’s ability to access new medicines.

As the UK would become a standalone regulator, only medicines approved by the MHRA would be able to reach the UK market, it says. At present, medicines authorised through the European Medicines Agency can be sold throughout the EU, including the UK, even if the initial assessment has been carried out in another member state.

In future however, a separate assessment of a new medicine would need to be carried out by the MHRA, which acknowledges companies may choose not to submit such an additional application ‘due to business decisions.’

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

ABPI responds to MHRA consultation on ‘no deal’ legislative proposals

ABPI, Press Release, 4 October 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on how its legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period.

The ABPI will study the proposals in detail and will submit a response in due course. Welcoming the news, the ABPI’s Deputy Chief Scientific Officer Dr Sheuli Porkess said:

“It is important that the UK puts plans in place for a ‘no deal’ Brexit. Pharmaceutical companies continue to plan for all possible outcomes from the negotiations and we will continue to work closely with the Government on their plans.

“But we have been very clear that the best way to protect patients and public health in the UK and in the EU is to agree future cooperation between the MHRA and the EMA on the regulation of medicines.

“We continue to urge both the UK and EU negotiators to 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.”

About the ABPI

The ABPI represents innovative resea​rch-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.

Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome disease.

Globally our industry is researching and developing more than 7,000 new medicines.

The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.​​​​​​​

Drugs regulator warns on no-deal Brexit access to new medicines

Financial Times, Sarah Neville, 4 October 2018

A no-deal Brexit would threaten Britons’ ability to access new medicines, the UK drugs regulator has warned.

In a consultation paper on future arrangements for scrutinising treatments and medical devices in the “unlikely” event that Britain quits the EU without a deal, the Medicines and Healthcare products Regulatory Agency also acknowledged there would be “costs” to business as it coped with additional regulatory hurdles to sell products in the UK.

As the UK would become a standalone regulator, only medicines approved by the MHRA would be able to reach the UK market, it says. At present, medicines authorised through the European Medicines Agency can be sold throughout the EU, including the UK, even if the initial assessment has been carried out in another member state.

In future however, a separate assessment of a new medicine would need to be carried out by the MHRA, which acknowledges companies may choose not to submit such an additional application “due to business decisions”.

Ian Hudson, MHRA chief executive, said the agency wanted to “retain a close working partnership with the EU” and its blueprint was designed to ensure “that patients should not be disadvantaged, that innovators should be able to get products to the UK market as quickly and simply as possible, and that the UK continues to play a leading role promoting public health”.

But the world market for drug sales is estimated to be worth $844bn, of which the UK commands only about 2.6 per cent. Observers believe this will leave companies with a conundrum as to whether — and how quickly — it is worth negotiating a further bureaucratic hurdle to bring a particular medicine to the UK market.

Indicating the additional requirement may deter some companies from bringing innovative products to the UK, or leave payers shouldering higher costs, the MHRA paper acknowledged a potential impact “on access to certain medicines and therefore to public health”.

It suggested manufacturers would be likely to “seek to recoup these additional regulatory costs through price increases, which would affect NHS budgeting and spending choices”.

Niall Dickson, co-chair of the Alliance, who also leads the NHS Confederation of senior health managers, said: “We know that countries outside the European Medicines Agency can experience delays.”

“We have to find a way of exiting the EU without disrupting access to innovative and safe medicines both for patients in the UK and in Europe.”

The document, on which responses are invited by next month, says its aim is to “ensure continuity in the safety of medicines and devices in the UK, while retaining the UK regulator’s ability to take regulatory action to protect public safety”.

The MHRA said it wanted to achieve its objectives “with minimum disruption and burden on businesses, and with minimum disruption to the supply of medicines and devices in the UK”.

It cited its decision that products that have been approved in Europe before Britain leaves the EU should be converted into UK marketing authorisations and a “time-limited” recognition of the European Kitemark for medical devices, known as the CE mark.

Media And Political Bulletin – 05 October 2018

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