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31 October 2017

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P3 Pharmacy, 30 October 2017

P3 Pharmacy reports on the HDA’s submission to the Health Select Committee’s inquiry on Brexit. The article highlights the HDA’s concerns regarding price hikes on NHS medicines and an increase in red tape on imports which could have a serious effect on the post-Brexit UK medicines supply chain and put patient safety at risk. P3 Pharmacy reports that the HDA has called for both a transitional period during which the status quo is maintained and the formulation of a sustainable long-term approach.

BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 30 October 2017

Pharmacy Business reports that the British Generic Manufacturers Association has reassured community pharmacists who have struggled to source products in the wake of generic drug shortages that its members are working with the Department of Health to find solutions and ensure “any impact on patients is kept to an absolute minimum.”

When asked if he was aware of generic shortages at Bristol Labs and Dr. Reddy’s or any other of its members, BGMA director general Warwick Smith told Pharmacy Business: “A regulatory issue is currently limiting the supply of some medicines. The industry is working with the Department of Health to identify alternative sources of supply so that any impact on patients is kept to an absolute minimum”.

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P3 Pharmacy, 30 October 2017

Price hikes on NHS medicines and an increase in red tape on imports could have a serious effect on the post-Brexit UK medicines supply chain and put patient safety at risk, the Healthcare Distribution Association has said. The Association has called for both a transitional period during which the status quo is maintained and the formulation of a sustainable long-term approach.

The Association, which represents businesses that supply medicines, medical devices and healthcare services, was responding to the Health Select Committee’s Brexit inquiry.

Customs and tariffs

Answering the Committee’s question regarding the key considerations for companies, healthcare service and regulatory bodies, it outlined scenarios that could see changes to customs and tariffs affect the “timely and cost-effective supply of medicines to patients”, including prohibitive tariffs on imported medicines and significant increase in the administrative burden for imports before they reach the UK.

In addition, the loss of equivalence with EU legislation would make it difficult for manufacturers to bring products to the UK as quickly as happens currently, the HDA said, adding that “greater clarity on future regulatory and trading relations is required as soon as possible if patient safety is not to be put at risk.”

The HDA said: “The government must urgently agree not only a transitional arrangement with the EU for these issues, but a long-term and sustainable way forward that provides the medicines supply chain with the much-needed certainty that it requires to deliver the right medicine, in the right place at the right time for patients across the UK.”

Parallel imports

Leaving the common trademarks system and the free movement (or ‘parallel trade’) of medicines this allows– a state of affairs that could be permanent in the event of a ‘hard Brexit’ – is also likely to increase the risk of medicines shortages, the HDA said, and could lead to price hikes for NHS medicines.

To avoid these harmful effects, the government “must consider sector-by-sector deals on IP rights, agreeing to mutually recognise certain products, such as pharmaceuticals,” the HDA said.

Stresses on the supply chain post-Brexit could affect the UK’s ability to implement the Falsified Medicines Directive by the February 2019 target date, the HDA added.

BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 30 October 2017

The British Generic Manufacturers Association has reassured community pharmacists who have struggled to source products in the wake of generic drug shortages that its members are working with the Department of Health to find solutions and ensure “any impact on patients is kept to an absolute minimum.”

The PSNC said last week it was in “urgent” talks with the DoH over “price concessions and wider concerns” following reports that contractors were enduring a shortage of generic drugs from Bristol Laboratories and Dr. Reddy’s.

When asked if he was aware of generic shortages at Bristol Labs and Dr. Reddy’s or any other of its members, BGMA director general Warwick Smith (pictured) told Pharmacy Business: “A regulatory issue is currently limiting the supply of some medicines.

“The industry is working with the Department of Health to identify alternative sources of supply so that any impact on patients is kept to an absolute minimum.

“Due to the multi-source nature of the UK generics market, when occasional supply issues of this kind arise, other manufacturers are usually able to increase production to mitigate any potential supply shortfall. Our focus and priority is on quality and security of supply.”

Rajiv Shah, a director at Sigma Pharmaceuticals, told the Avicenna conference in northern Cyprus in 2015 that generic drug shortages were costing independent pharmacists in England £10 million a year.