Anatomy of the cost of a new drug

Source: BBC News

20 Aug 2014

Pills and dollar bills

The cost of drugs is in the headlines following the decision by NHS watchdog NICE that a new cancer treatment should not be funded.

Its cost? More than £90,000 per patient for an extra six months of life. But how are such figures reached?

The drug – Kadcyla – was developed by Roche.

And for commercial reasons it has so far not revealed the methods behind its pricing strategy.

Lab testing and trials

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Philip Morris prepared to sue UK over plain cigarette packaging

Source: Reuters

19 Aug 2014

Packs of Marlboro cigarettes are displayed for sale at a convenience store in Somerville, Massachusetts July 17, 2014.       REUTERS/Brian Snyder

Packs of Marlboro cigarettes are displayed for sale at a convenience store in Somerville, Massachusetts July 17, 2014.

(Reuters) – Philip Morris International, the world’s largest tobacco company, is prepared to sue the British government should it implement a law requiring plain packaging of cigarettes, a document seen by Reuters on Tuesday showed.

 

The UK government has conducted a consultation with its Department of Health on potential legislation which would force cigarette makers to sell their products in plain packages with graphic health warnings and no branding.

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Tobacco producing countries will battle packs law

Source: Irish Examiner

19 Aug 2014

Tobacco producing nations are expected to challenge Ireland’s move to outlaw branded tobacco packaging, the new junior jobs minister has been warned by his department.

Ireland will likely face a constitutional challenge and complaints to the World Trade Organisation (WTO) over the anti-smoking move, Ged Nash was told by his officials.

Countries and firms are watching events as it may dictate how governments legislate for other harmful goods such as alcohol and fats, officials say. Global tobacco giant Philip Morris also said this week it would sue Britain for £11bn if plain packaging for cigarettes is enforced there.

Documents obtained by the Irish Examiner show officials told Mr Nash that Ireland faces “scrutiny and questioning” on the new law at a key WTO meeting in November.

Australia is already facing challenges from Cuba and Indonesia among nations to its ban on tobacco branding. The tobacco producing countries claim the rules breach trade and intellectual property regulations.

Department of Jobs, Enterprise and Innovation briefing notes for Mr Nash released under Freedom of Information outline what lies ahead for Ireland in the tobacco dispute.

“Ireland might expect to have (a) a constitutional challenge and (b) to have complaints against it at the WTO, by producing countries,” it states.

The notes were drawn up by two department assistant secretaries general.

Following publication in June by the Government of the plain packaging legislation, the bill was sent for approval to the European Commission and WTO.

Objections can be lodged with the commission until December, while the WTO will discuss barriers to trade the law may create at a meeting later this year. TDs will not have a final vote on the law until 2015, after it is examined in Brussels.

The private briefing papers, given to Mr Nash last month, say Ireland has “come under scrutiny” at a WTO committee on technical barriers to trade. This is “because our new legislation on tobacco is seen by some WTO members as inhibiting fair trade under the rules” of the organisation.

Formal dispute settlement proceedings against Australia through the WTO have already been brought by Cuba and Indonesia over plain tobacco packaging there. The briefing for Mr Nash notes that up to 30 countries are monitoring that case and this indicates “the extent of interest” in the ban.

Any legal case against Ireland will be taken on constitutional grounds with claims the packaging ban infringes intellectual property rights under article 40 and 43.

Tobacco companies could lodge massive claims. But the Government is expected to argue that property rights have to be balanced with social good, such as public health. Health charities say the branding ban may reduce the 5,200 yearly smoking-related deaths.

Australia has already defeated a similar legal challenge. Smoking rates there dropped by 15% in recent years.

The dispute may also have implications on how alcohol, sugar and fats are legislated for, officials say.

The Irish Examiner revealed this week that German businesses and MEPs asked Enda Kenny to scrap the plans.

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Patent controller issues revised “draft guidelines for examination of patent applications in the field of pharmaceuticals”

Source:  Pharmabiz

19 Aug 2014

The Indian Patent Controller has released the revised “draft guidelines for examination of patent applications in the field of pharmaceuticals” which will help the examiners and the controllers of the patent office in achieving consistently uniform standards of patent examination and grant of patents.

On Section 3(d) of the Patent Act, the revised guidelines explains that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant are not patentable inventions within the meaning of the Act.

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The Limits of the Patent System

Source: Random Thoughts on R&D, Innovation, IP and IT

14 Aug 2014

 

Do Patents Kill Innovation?

Do patents kill innovation? Evidence is piling up that they do. This time the evidence is from the pharmaceutical industry itself. The strongest case for patent has been made out in the pharmaceutical industry. Since pharmaceutical research is inherently risky and requires substantial investment, it is argued that the sector requires a strong patent protection.

It is in cancer drug discovery that evidence has come out that patents destroy R&D. A paper, “Do fixed patent terms distort innovation? Evidence from cancer clinical trials” by Eric Budish of University of Chicago, Benjamin N. Roin of Harvard Law School and Heidi Williams of MIT demonstrates, through empirical study, how patent system distorts R&D for cancer therapy. The paper finds that patents generate distorted R&D incentives, in the case of cancer. Cancer research, particularly for early stage cancer, which is curable, requires long clinical trials. Therefore industry prefers to invest in R&D for metastatic cancers, which requires less duration trials, but the therapy may prolong the life by only a few months. This is of significant concern from a medical perspective.

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The Ebola outbreak’s real cause: Letting industry drive the research agenda

Source: Vox

5 Aug 2014

It’s been nearly 40 years since the discovery of Ebola, yet we’re dealing with its deadliest outbreak in history and one that is four times larger the first.

Back then, in 1976, the scientific community knew nothing about the hemorrhagic fever. Blood containing the mystery virus was innocently sent in a blue thermos to Belgium, where Flemish scientists figured out they were unwittingly handling a violently lethal pathogen, and named it after a river in what was then Zaire.

Since then, we’ve learned a lot about Ebola: that it’s spread through contact with the bodily fluids of an infected person, that we can stop it by using simple precautionary measures and basic hygiene practices. But every once in a while, these nightmarish outbreaks pop up and capture the international imagination. Worries about global spread are worsened by the fact that Ebola has no vaccine and no cure.

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Sun-Ranbaxy combine to control over 40% market for 25 drugs

Source: The Economic Times

5 Aug 2014

NEW DELHI: Sun Pharma will have a market share of over 40% in 25 drugs once it takes control of Ranbaxy, according to an ET analysis, that may be reason for a close look at the deal by the competition watchdog that has begun to examine the biggest deal in the Indian pharma industry.

For nine drugs its market share will be more than 65% and in another 15 it will be 40-60%, revealed an analysis of the latest data from market research firm AIOCD Awacs.

Sun-Ranbaxy combined market share to be 9.5%

In addition, there are 11 drugs in which the Sun-Ranbaxy combine will enjoy a 33-40% market share. In all, the two companies have 128 common formulations.

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