Drug Regulation

Is the Indian Drug Controller Participating in the ACTA Negotiations?


Pursuant to our post lamenting the “secrecy” with which the ACTA (Anti Counterfeiting Trade Agreement) negotiations were shrouded, an anonymous source writes to inform us thus:

“I am afraid that the new Indian Drugs Controller General is being briefed about the Treaty , its objectives etc as he has been (unlike any before him) invited to Canada and USA. The Indian Govt has become too inward- concerned to worry about these “conspiracies” concerning IP treaties from the West!”

SpicyIP hasn’t verified this news as yet–but if any of our readers have more information on this, please let us know.

Looks like our DCGI (Drug Controller General of India), Dr Surinder Singh is a hot favourite in the international IP circles now. Not least because he’s been very enthusiastic about framing rules to link up drug regulatory approval with patents. Except that he forgets that there exists something called the Constitution of India, under which any overstepping of statutory bounds is likely to be challenged by a writ petition and struck down by a court!

Apart from this, he fails to appreciate that such linkage is bad policy on two counts. For one, it delays generic entry unduly. And secondly, and more importantly, he forgets that he does not have the expertise or the time to take informed calls on complex “patent issues”. Particularly, when his own house is not in order. He has to first ensure that that his office does a good job at what they were statutorily mandated to do i.e. approve drugs that are safe and effective for the Indian consumer. And not stick his neck out and increase his workload by taking on complex patent issues.

Anyway, from this ICC (International Chamber of Commerce) letter here, it seems that the ACTA was discussed quite extensively in Hokkaido, Japan at the recent G-8 summit.

To

The Honourable David Emerson
Foreign Affairs and International Trade Canada
Office of the Minister for International Trade
125 Sussex Drive
Ottawa,Ontario K1A 0G2
Canada

5 June 2008

Dear Minister,

The International Chamber of Commerce created BASCAP – Business Action to Stop Counterfeiting and Piracy – to represent member companies concerned by the global magnitude and increasing damages and dangers caused by the illicit trade in fake and pirated goods. Counterfeitingand piracy pose huge risks for consumers and to the growing importance of intellectual capital toresearch, innovation, international trade, investment, and sound economic growth and development. We have provided our views on this matter and our recommendations for priority action to G8 Ministers prior to summits in Gleneagles, St. Petersburg and Heiligendamm.

We recognize that G8leaders have progressively advanced their understanding of and resolve to tackle this global challenge. This was evidenced by the declaration in Heiligendamm, which stated, “the benefits ofinnovation for economic growth and development are increasingly threatened by infringements ofintellectual property rights worldwide.” Moreover, we were encouraged by the G8 leaders’ decision to“strongly reaffirm our commitment to combat piracy and counterfeiting.”Unfortunately, there has been little indication that these words have been translated to action. While we are again pleased that protection of intellectual property rights will be among the priority topics for discussion at this year’s G8 Summit, Hokkaido Toyako presents an excellent opportunity for the G8 to demonstrate leadership and to carry through on past declarations through attention to two priorities:

1. The establishment of the Heiligendamm Process to address the issues of product counterfeiting and copyright piracy has the potential to provide a tangible, enduring implementation mechanism. Continued commitment to the Heiligendamm Process is indispensable to the ability of the G8 to contribute value to the resolution of counterfeitingand piracy and to provide leadership to the many non-G8 governments who look to theguidance and precedents established by the G8. Therefore, as you prepare for the Summit thisyear, we urge you to commit the resources and political direction necessary for theHeiligendamm Process to effectively work against intellectual property theft and facilitate innovation and economic development.

2. The Hokkaido Toyako Summit also comes at a time when seven of the eight G8 governments are actively negotiating the proposed Anti-Counterfeiting Trade Agreement (ACTA). These negotiations provide the first real opportunity in years to build upon existing multilateral frameworks, provide tangible deterrents to IP crimes, and elevate standards for government performance in protecting against intellectual property theft. We would hope that one of the key outcomes of the Hokkaido Toyako Summit will be a strong, visible commitment to a swift conclusion of an Anti-Counterfeiting Trade Agreement that sets new, higher standards for national and international government action to deal with counterfeiting and piracy. A declaration from the G8 Summit calling on the negotiators to conclude a substantive agreement will help ensure we enter a new era where governments around the world assume the responsibility to curb this brazen, illegal activity.

ICC’s BASCAP initiative represents a visible and tangible example of the commitment by the international business community to contribute, on its own and in collaboration with governments, todevelop and implement programmes to bring an end to counterfeiting and piracy and improve theprotection of intellectual property. BASCAP stands ready to support the Heiligendamm Process, elaboration of ACTA and initiatives you may put forward this year that will help deal with this growing international problem.

Kind regards,
Guy Sebban

Attachments:BASCAP 2007 Statement2008 Business views on ACTA”

This letter also shows the heavy involvement of Canada in the ACTA, as it is addressed to Canadian Minister of International Trade, David Emerson, who goes out of his way to defend the ACTA here. (Or perhaps this ICC letter was addressed to all G-8 leaders).

It’ll be interesting to know what transpired at the Hokkaido proceedings on this treaty. Any of our Japanese readers have more details on the Hokkaido proceedings? We’re guessing that our Japanese constituency has increased after our numero uno pharma company, Ranbaxy decided to “sell out” (oops sorry, wrong word: lets try “strategically align itself”) with a Japanese pharma giant, Daichi Sankyo.

Interestingly, this summary of the proceedings at Hokkaido makes clear that India and some other developing countries (Brazil, China, Mexico, Philippines and South Africa) participated as guests. The earlier Outreach 5 (countries invited to be guests at the G-8 summits) has now increased to 8 members (Australia, Brazil, China, India, Indonesia, Mexico, Korea and South Africa) all of whom were invited to Hokkaido.

To get the latest on this controversial and clandestine treaty (perhaps it should be retitled as “A Clandestine Trade Agreement”), check the KEI listserves (we provided links to these in our last post), Michael Giest’s blog and the IP Justice website.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

2 comments.

  1. AvatarShamnad Basheer

    Dear Yogi,

    Thanks for your detailed and well thought out comment. I’m still asking around for more information on the DCGI’s participation and will et you know shortly. Most of the folks that I have spoken to about this are tightlipped. I’m sure they’ve roped in him using the “counterfeit medicine” mantra.

    You’re absolutely right–what is imperative is that the governemtn get all the IP departments together and evolve some sort of a national IP policy strategy. Else we’ll end up with more Dr Mashelkar vs Debabrata Saha (Indian Rep at UN) controversies re: the SPLT.

    And you’re suggestion for a petition to have a national IP policy is a very welcome one. Let me think through this and see if we can work together on evolving such a petition.

    Thanks again,

    Shamnad

    You’re right–this is a serious co-ordination problem between ministries as well. Wil let you know upon further information.

    Reply

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