Competition Commission of India pulls up Roche for anti-competitive practices

By Jyotsna Singh, Scroll | April 27, 2017

In a landmark order, the commission has initiated an investigation into the multinational pharmaceutical company’s activities.

The Competition Commission of India has initiated an investigation into Swiss pharmaceutical giant Roche for unfair business practices. Roche has been found, prima facie, of misusing its dominant status to keep competition out for its breast cancer medicine Trastuzumab. Continue reading

Posted in Biologics/Biosimilars, Campaign for Affordable Trastuzumab, Cancer, Uncategorized | Tagged , , , | Leave a comment

Pharma Companies Should Sell Medicines Under Generic Names! Generic Prescription by Doctors is NOT Enough

Press Release: April 26, 2017

All India Drug Action Network Demands Substantive Measures 

 The proposal, as announced by the Prime Minister, to make generic prescription writing mandatory for doctors, would be a useless counterproductive step as a standalone measure. This is because in India no manufacturer markets medicines in the retail market under generic names and hence medicines are not available under generic names in the Indian retail pharmacy shops.  Unless manufacturers (except those who are marketing medicines still under patent protection) are made to market medicines under generic name for the retail market, consumers will not get the benefit of  ‘generic medicines’. In the absence of universal availability of good quality generic name medicines in retail pharmacy shops, merely getting  doctors to start prescribing medicines under generic name will end up in shifting the discretion to pharmacists who will are likely to dispense brands that give them more commission. Continue reading

Posted in Drug prices, Generics, Uncategorized | Leave a comment

Deputy foreign minister named as Japan’s chief TPP negotiator

Source: Bilaterals.org

The government announced Tuesday that it has appointed a deputy foreign minister as chief negotiator for the Trans-Pacific Partnership free trade pact, with an eye to bringing the deal into force without the United States.

Keiichi Katakami takes up the post while still holding his deputy ministerial role. The post of TPP chief negotiator has been vacant since Hiroshi Oe became head of the Japanese diplomatic mission at the OECD in February. Continue reading

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Treating intellectual property as an investment, and subjecting it to treaty arbitration, can have undesirable impact

Published: The Economic Times | April 17, 2017

By Feroz Ali & Devika Agarwal

Global giants like Vodafone and Cairn Energy have raised investment disputes against India by initiating arbitration proceedings under investment treaties. Free trade agreements (FTAs), like the Regional Comprehensive Economic Partnership that India is currently negotiating with other countries, tends to treat intellectual property (IP) as an investment made by investor corporations, allowing private investment disputes to be raised against the host country whenever there is a threat to their IP. Continue reading

Posted in BITS, ISDS, Regional Comprehensive Economic Partnership, Uncategorized | Leave a comment

The expanding universe of IP

Source: The Hindu

Granting data exclusivity for clinical trials would undermine access to medicines

April 26 is World Intellectual Property (IP) day. Over the years, global IP standards have steadily expanded beyond World Trade Organisation (WTO) requirements, thanks to free trade agreements such as the Regional Comprehensive Economic Partnership (RCEP) which India is currently negotiating with its trading partners. But there is new cause for worry. Apart from increasing the scope of existing IP rights, there is a move to create new IP-like rights. A case in point is data exclusivity exclusivity over clinical trial data submitted by drug companies to the regulatory authorities for market approval, the grant of which could severely undermine access to medicines.

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Posted in Data Exclusivity, TRIPS, TRIPS flexibilities, TRIPS plus, Uncategorized | Leave a comment

CCI to investigate Swiss drugmaker Roche over breast cancer biosimilar

By Divya Rajagopal, The Economic Times | April 26, 2017

MUMBAI: The Competition Commission of India (CCI) will investigate Swiss drugmaker Roche over alleged attempts to block competitors from selling breast cancer drug Trastuzumab.

The investigation has to be completed in 60 days.

CCI’s action is in response to a complaint filed by Mylan and Biocon, who have together developed biosimilar version of Roche’s blockbuster drug that is most commonly prescribed for the treatment of breast and metastatic gastric cancer. Continue reading

Posted in Biologics/Biosimilars, Campaign for Affordable Trastuzumab, Cancer, Uncategorized | Tagged , , , , | Leave a comment

Indian competition commission issues a path breaking order on abuse of dominant position in pharmaceuticals

Rules Roche’s practices prima facie appear to be aimed at blocking affordable biosimilar trastuzumab – a cancer drug – in India

In July 2016, Mylan Pharmaceuticals and Biocon Limited approached the Competition Commission of India regarding Roche’s anti-competitive conduct to protect and maintain its monopoly on the biologic drug Trastuzumab used in the treatment of HER2-positive breast cancer. According to the complaint, the Swiss pharmaceutical corporationhas been denying market access to its competitors through array of activities like influencing regulatory standards, raising unwarranted concerns regarding the safety and efficacy of biosimilars, influencing tender conditions and abusing the legal process to stall approval and marketing of the biosimilar. Roche misused its dominant position to try and block more affordable biosimilars developed in India.

The Competition Commission in a path breaking decision (Case No. 68 of 2016 – Roche – Mylan Biocon CCI Order 68 of 2016) has ruled that the complaint has merit  relating to abuse of dominant position by Roche has merit and that the pending Civil Suit in the Hon’ble Delhi High Court does not impede the Commission’s jurisdiction to look into the present matter (para 41).

Highlights of the order

Thus, the practices adopted by Roche Group to create an impression about the propriety of the approvals granted, the safety and efficacy of biosimilars, the risk associated and the outcome of the on-going court proceedings in the medical fraternity, including doctors, hospitals, tender authorities, institutes etc., when seen collectively, prima facie appear to be aimed at adversely affecting the penetration of biosimilars in the market (para 74).

The Commission is of the considered opinion that biological drugs as well as its biosimilars form part of the same relevant product market. In the present case, the relevant product market, thus, would be the “market for biological drugs based on Trastuzumab, including its biosimilars” (para 49)

Even a partial denial of market access that takes away the freedom of a substitute to compete effectively and on merits in the relevant market, may amount to a contravention of Section 4(2)(c) of the Act (Para 77).

Based on the foregoing analysis, the Commission is of the considered view that prima facie, the contravention with regard to Section 4(2)(c) of the Act is made out against Roche Group, which warrants detailed investigation into the matter. The DG is, thus, directed to carry out a detailed investigation into the matter, in terms of Section 26(1) of the Act, and submit a report to the Commission, within 60 days (para 81).
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Posted in Anti competition, Biologics/Biosimilars, Campaign for Affordable Trastuzumab, Cancer | Tagged , , , , , | Leave a comment