HDA Media And Political Bulletin – 23 November 2016

House of Commons Questions;

 

Nigel Adams tabled a question on the Pharmacy Integration Fund which was answered by the Pharmacy Minister, David Mowat, on 21 November 2016.

 

Crispin Blunt tabled a question in regards to the Pharmaceutical Price Regulation Scheme. This was answered on 21 November 2016 by Nicola Blackwood from the Department of Health.

 

Parliamentary Coverage

House of Commons Questions, Pharmacy, 21 November 2016

Health

 

Nigel Adams: If his Department will bring forward a community pharmacy (a) campaign and (b) audit on unwanted medicines.

 

Department of Health

 

David Mowat:

The Pharmaceutical Services Negotiating Committee (PSNC) put forward a range of service development and counter proposals during the course of the consultation with them on community pharmacy in 2016/17 and beyond. These proposals were all given full consideration by the Department. The final package contained two of the PSNC’s counter proposals – the proposal to introduce a quality payment, and the proposal for an urgent supply of medicines scheme.

 

The independent review being conducted by Richard Murray, of the King’s Fund, will consider what clinical services should be provided by community pharmacy in the future, and how they should be commissioned.

 

The Pharmacy Integration Fund will be used to commission and evaluate activities that bring about clinical pharmacy integration within the National Health Service demonstrating improvements in health outcomes for patients and the public in primary care and in the community.

 

House of Commons Questions, Pharmaceutical Price Regulation Scheme, 21 November 2016

Health

 

Crispin Blunt: What discussions he has had on enhancing consultation with stakeholders on the Pharmaceutical Price Regulation in the preparation and conduct of the forthcoming negotiations on the next such Scheme, in particular with industry bodies representing companies directly affected through their participation in the Scheme.

 

Department of Health

 

Nicola Blackwood:

We have not had any discussions relating to a successor to the current five-year Pharmaceutical Price Regulation Scheme, which came into effect on 1 January 2014.

Full Coverage

There is no media coverage today.
Drug shortages prompt question: are some medicines too cheap?

1 April 2016, Reuters, Ben Hirschler

 

Shortages of essential drugs, primarily those whose patent has expired, are becoming increasingly frequent globally. Shortages are a result of a variety of factors, including low prices driving manufacturers out of the market. The result is a fragile supply chain, increasing the risk of counterfeit drugs. The topic will be discussed at the WHO World Health Assembly in May.

 

Pharmacy Voice: ‘Essential’ to discuss funding with DH

4 April 2016, Chemist + Druggist, Annabelle Collins

 

Pharmacy Voice has called for additional meetings with the Department of Health to discuss how the government’s planned Pharmacy Integration Fund should be used. In a letter to NHS England, Pharmacy Voice stated that the Integration Fund should be used to “open up opportunities for community pharmacy”.

 

Parliamentary Coverage

 

There is no Parliamentary Coverage today.

 

Full Coverage

Drug shortages prompt question: are some medicines too cheap?

1 April 2016, Reuters, Ben Hirschler

 

Philip Aubrey buys medicines for British government-funded hospitals across London, capital of the world’s fifth-largest economy, but last year he struggled to secure supplies of a basic AIDS drug.

 

He is not alone. Shortages of essential drugs, mostly generic medicines whose patents have long expired, are becoming increasingly frequent globally, prompting the World Health Organization (WHO) to suggest minimum prices may be needed to keep some products on the market.

 

Drug shortages are due to a variety of factors from manufacturing, quality and raw material problems to unexpected spikes in demand, but such upsets are aggravated when there are few suppliers.

 

“It can be really problematic,” said Aubrey.

 

The rise in shortages has gone hand in hand with a wave of consolidation among the companies making generic drugs – which range from global pharmaceutical giants to smaller firms in countries such as India – reducing the number of manufacturers making individual product lines.

 

Downward pressure on generic drug prices is good news for healthcare systems in the short term, but it may fuel disruption if a supplier hits production problems. While the lack of a patent means other suppliers could also make the same drug, they would still need regulatory approval and that can take years.

 

The result, according to experts, is a worryingly fragile supply chain, particularly for injectable medicines such as chemotherapy treatments and certain antibiotics.

 

Benzathine penicillin, for example, a vital drug for preventing transmission of syphilis from mother to child, has been in short supply for years because of manufacturing problems, inconsistent demand and a relatively low price.

 

“Medicines can be too cheap,” said Hans Hogerzeil, professor of global health at Groningen University in the Netherlands and a former director for essential medicines at the WHO. “For a viable market model you need at least three and preferably five different manufacturers.”

 

The idea of minimum prices for certain essential medicines contrasts sharply to traditional pricing debates about how to reduce the sky-high cost of new patented drugs for diseases such as cancer and hepatitis C.

 

Drug shortages will be discussed as a specific topic for the first time at this year’s WHO World Health Assembly in May, and U.S. and European regulators told Reuters more needed to be done to address the problem.

 

Shortages in the United States hit a peak in 2011 due to manufacturing outages, yet the American Society of Health-System Pharmacists still lists 155 products as being in short supply.

 

The European Association of Hospital Pharmacists says more than four out of five of its members face regular shortages, while doctors in Canada have been grappling this year with tight supply of a widely-used epilepsy drug.

 

COUNTERFEIT RISK

 

Shortages in developing countries can go unreported for months or even years, increasing the risk of counterfeits entering the supply chain, according to Lisa Hedman, a procurement and supply chains expert at the WHO.

 

Hedman was an author on a WHO report released earlier this year setting out possible ways to tackle the problem.

 

These include a global notification system for supply problems, increased collaborationbetween regulators and potential advanced purchase commitments for priority drugs, as well as action on pricing.

 

Low-cost generic manufacturing has produced huge benefits in increasing drug affordability but the report warned: “Too low prices, however, may drive manufacturers out of the market.”

 

Valerie Jensen, associate director of the U.S. Food and Drug Administration’s drug shortage program, believes global action could complement national measures, such as a new FDA policy to speed reviews of generics competing with only one other product.

 

“We know that internationally this is a problem and we need to think of ways to address it,” she said.

 

Drug regulators themselves have limited scope for action, since while they can keep a drug off the market, they cannot require a company to make a product.

 

“We need to sweet talk manufacturers to get them to think about best practices,” said Brendan Cuddy, head of manufacturing and quality compliance at the European Medicines Agency.

 

Brendan Shaw, assistant director general at the International Federation of Pharmaceutical Manufacturers and Associations in Geneva, argues that recognising the need to keep generic drugmakers financially viable is essential.

 

“Companies don’t like stock-outs either, so it is in everyone’s interest to find a way forward,” he said.

 

In London, medicines buyer Aubrey has now resolved the supply difficulties he faced over the HIV/AIDS treatment nevirapine, after one generic supplier eventually fixed its production problems, but he is still struggling to get supplies of other important drugs.

 

These include the bladder cancer therapy BCG and even diamorphine, or heroin, the powerful painkiller sometimes given to end-stage cancer patients.

 

As the man holding the purse strings, Aubrey needs to get a good deal on price but he worries that a couple of hundred medicines in Britain now have only one supplier.

 

“We need a balance,” he said. “It’s not good news if there is a shortage and patient care is compromised.”

From Factory to Pharmacy

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