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News and Events - 18 Mar 2012




16.03.2012 14:00:00

Lynne Taylor

Drugmakers' fury as China plans to widen price-cutting system

Domestic and multinational drugmakers in China have strongly criticised government plans for a wider roll-out of a piloted competitive tendering system for medicines procurement which has been shown to cut the prices of essential drugs by at least 30%.

The plans were announced at the annual National People's Congress in Beijing, where national leaders said the tendering system would be rolled-out further to support an increase in state health insurance coverage and moves to make health care more affordable.

Although the tendering scheme was piloted in five Chinese provinces, it is generally referred to as the "Anhui model" because in Anhui, the country's fourth-poorest province, it has been shown to reduce prices of essential drugs by an average of 53% below their officially-set maximum retail prices, with some price levels being slashed as much as 90%.

"The tendering system that we have implemented for basic drugs has proved to be effective and able to guarantee the drugs' safety, reasonable price and timely supply. Our next step is to further improve on these plans," Bloomberg reports Sun Zhigang, deputy director of the National Development and Reform Commission and head of the health care reform bureau at the State Council, as saying.

Currently, the tendering system covers 307 essential drugs but Ministers want to increase this to around 800 products, and also to cover the procurement of more expensive drugs used in hospitals in the treatment of diseases such as cancer. Research-based drugmakers say that doing so would force them to compete on price with generics makers, but supporters of the proposal point out that most such drugs are expensive imports.

While some observers feel that drugmakers will benefit as the government continues to add more products to the essential drugs list and extend state health insurance coverage to more and more of China's 1.3 billion population, others believe that manufacturers are being used as scapegoats and sector leaders are unhappy at the implications for their industry of a wider roll-out of the Anhui model. Several domestic firms have warned that their profits are likely to be cut as a result of the widening of the competitive tendering model, with some saying that they have already had to take a loss in order to sell their drugs to the authorities in Anhui.

The healthcare reform "is basically about tendering to compete on prices," but what needs to be prioritised is "guaranteeing quality first, rather than focusing on just prices, or this will be very unfair to China's drugmakers," Bloomberg quotes Guo Guangchang, chairman and co-founder of Fosun International, which controls the major drug maker Shanghai Fosun Pharmaceutical Co, as saying.

Last year, IMS Health forecast that drug spending in China will increase at the fastest rate globally during 2010-1015, with annual growth averaging 19%-22% and reaching as much as $125 billion by the end of the period.

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16.03.2012 20:38:00


  1. Ganapati Mudur

Author Affiliations

India’s controller of patents has granted the country’s first compulsory licence on a patented drug, allowing a domestic drug company to manufacture a generic version of Bayer’s sorafenib tosylate (marketed as Nexavar , used in chemotherapy for hepatic and renal cancers.

Natco Pharma asked for the right to manufacture sorafenib tosylate, saying that it would make available a generic version that would cost patients 8800 rupees (?110; ˆ135; $175 a month rather than the 280?000 rupees a month it costs for Bayer’s product. The controller granted the licence and ruled that Natco Pharma should pay Bayer a royalty fee of 6% on sales of the generic version.

Experts in public health who have been campaigning for better access to inexpensive generic drugs have hailed the controller’s decision, but sections of the pharmaceutical industry have said that compulsory licensing should be invoked only in public health emergencies and not to reduce the prices of drugs.

Bayer, which has the right to appeal, has said it is disappointed by the decision.

However, patient support groups are looking forward to more compulsory licences in other therapeutic areas. Yogendra Sapru, chief executive of the Cancer Patients Aid Association, said in a statement released after the controller’s decision this week, “Many other cancer medicines are sold at exorbitant prices in India.”

A single vial of patented trastuzumab (Herceptin , which is used in combination with paclitaxel to treat metastatic breast cancer, costs about 132?000 rupees in India, says a report from the Centre for Trade and Development, a policy think tank in New Delhi.

Malluparambil Santhosh, associate fellow at the think tank, said, “Herceptin chemotherapy in India is currently beyond the reach of the vast majority of patients who need it.”

A patented version of interferon used to treat hepatitis C virus infection is another example of a drug that most patients can’t afford, he said.

A senior health economist said that India will need to use all available tools to reduce prices of drugs given the government’s plans to introduce universal healthcare, including free drugs, announced last year (
BMJ
2011;343:d6774, doi:
10.1136/bmj.d6774 .

Sakthivel Selvaraj, an economist with the Public Health Foundation of India, New Delhi, said, “Compulsory licensing fits in with the goal of government procurement of drugs and distribution of free medicines for inpatient and outpatient healthcare.”

India changed its patent laws in 2005 to allow product patents on drugs, including the provision of compulsory licensing—as have other countries, as this is allowed under World Trade Organization rules. Brazil and Thailand have already used compulsory licences to make available antiretrovirals and anticancer drugs to their populations.

“India has been lagging behind on compulsory licensing despite huge expenses on drugs,” Dr Selvaraj told the
BMJ
. A nationwide survey of healthcare spending has shown that expenditure on drugs had accounted for about 68% of total personal spending on healthcare in India between April 2009 and March 2010.

The Organisation of Pharmaceutical Producers of India, which mainly represents international drug companies, has said that it has no objection to the use of compulsory licensing in a national emergency but believes that broadening its scope for “affordability” could result in the abuse of this provision.

India’s Association of Biotechnology Led Enterprises has said that it supports strong protection of intellectual property and opposes compulsory licences on “frivolous” grounds. “The government should clearly specify the criteria for issuing compulsory licences,” said Nandita Chandavarkar, its director of operations.

But health groups say that such reactions are predictable. “The idea that compulsory licensing should be limited only to emergencies is a myth promoted by multinational companies,” said Anand Grover, a director of Lawyers Collective, a non-government organisation that has represented cancer and HIV patients’ groups in court.

Mr Grover said that members of the World Trade Organization, including the United States and the European Union, had signed the Doha Declaration in 2001, which recognises the right to grant compulsory licences and the freedom to determine the grounds on which such licences are granted.

“India is likely to experience intense pressure from the developed countries and multinational corporations in the coming weeks to go slow on compulsory licensing,” said the Centre for Trade and Development’s Mr Santhosh.

Notes

Cite this as:
BMJ
2012;344:e2132

via
bmj.com

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16.03.2012 8:44:00

Recent shortages of critical drugs in the USA have hampered patient care and attracted much media attention. Sharmila Devi examines the problems with America's drug supply.
Severe shortages of drugs such as sterile injectables that have forced physicians in the USA to practise medicine from crisis to crisis are likely to continue for several more years, say regulators and health-care providers.
Around 280 drugs, almost all manufactured in the USA, remain in short supply because of factors including a dwindling number of makers of some drugs, deteriorating conditions in factories, and low prices for generics leading to a lack of investment to upgrade plants.
The shortages have led to delays in surgery and cancer treatments, left patients in pain, and forced hospitals to prescribe less effective treatment, said a review by the Associated Press late last year. At least 15 deaths in 15 months were blamed on the shortages, according to data compiled by the Institute for Safe Medication Practices, a patient safety group, and the true number might be higher because many deaths and injuries caused by shortages go unreported.
“We don't have any expectation the issue will be resolved soon”, Sandra Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, told The Lancet. “It will be several years before companies building new plants get them up and running.”

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17.03.2012 13:00:27



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15.03.2012 14:47:32
Source: Food and Drug Administration
Related MedlinePlus Page:
Drug Safety



16.03.2012 13:41:08
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generico Propecia pode reduzir o tamanho da glândula prostática nos homens com hiperplasia prostática benigna (BPH . A próstata é uma parte do sistema reprodutor masculino que produz um líquido leitoso de esperma. Aos 50 anos a maioria dos homens vêem a sua próstata alargar. Como a próstata se torna maior, pode restringir o fluxo da urina. Finasterida pode ajudar a reduzir os sintomas causados pelo BPH, como o fluxo urinário fraco ou interrompido; sensação de que a bexiga não está completamente vazia, necessidade de urinar com maior frequência, especialmente à noite; sensação urgente de ter de urinar logo; atraso ou hesitação quando começa a urinar. Finasterida também é utilizada no tratamento de certos tipos de queda de cabelo em homens. Finasterida não é utilizada em mulheres.


Avodart Genérico é usado no tratamento dos sintomas de hiperplasia benigna da próstata (BPH ou alargamento da próstata. A sua actuação ajuda também a reduzir o risco de obstrução urinária e a necessidade de operação à próstata. DUTASTERIDE é utilizado no tratamento da hiperplasia benigna da próstata (BPH nos homens. A BPH é responsável pelo alargamento da próstata.
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16.03.2012 8:47:00

Forest Laboratories (
$FRX could well be playing a dirge at corporate headquarters today. The company's leading drug,
Lexapro, now has new generic competition. Teva Pharmaceutical Industries (
$TEVA got FDA approval for its version yesterday, and immediately started shipping the product, putting some $2.9 billion of Forest's annual sales at risk.

Though Forest has been anticipating this event for years now, and has made some progress at filling the impending sales gap, it's not going to have an easy time over the next couple of years. Lexapro is far and away the company's biggest drug, accounting for around half its U.S. revenue.

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16.03.2012 23:14:00
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