[Ip-health] Reuters: U.S. industry body says India agreed to not issue 'compulsory' drug licences

Baker, Brook b.baker at neu.edu
Tue Mar 8 08:59:03 PST 2016

I think the article is more about constant U.S. pressure and Modi¹s
backdoor capitulation to the same.  In particular, the US government and
Big Pharma have been trying to insert the same kind of ³humanitarian²
clause in India¹s CL policy as they did in the August 30 Decision,
suggesting that compulsory licenses will not be pursued for commercial
reasons.  Of course, generic licensees have to earn sufficient,
sustainable revenue as compulsory licensees to actually want to enter a

Tahir¹s comment seems to suggest that the capitulation of the Modi
government is primarily because it is satisfied with voluntary licenses as
a solution to generic access.  However, generic licenses at present are
available only for a narrow spectrum of diseases, so it¹s hard to see how
a government could be satisfied with voluntary licensing only.  In
addition, except for emergencies, public-non-commercial use, and
competitive-based licenses, voluntary licenses are always a possibility in
the CL context because of the requirement of prior negotiation for a
commercially reasonable voluntary license, meaning you couldn¹t
necessarily avoid them even if you wanted to.

Voluntary licenses certainly are not getting people all of their access
needs, especially in Pharmerging MICs, but I don¹t think they are the
explanation for regressive policies on compulsory licensing.  Cls have
been underutilized throughout the post-TRIPS era, not just when voluntary
licenses were adopted.  I think we need to advocate for much greater use
of compulsory licensing and opposition strategies, but that doesn¹t
necessarily mean that voluntary licenses aren¹t part of the access matrix.
 Otherwise, we have to have successful oppositions (not possible for all
medicines) and near automatic compulsory licenses in a very wide range of
countries, and, in order to create markets, those effort need to be
coordinated.  Doing some of the wholesale work with voluntary licenses for
a significant portion of the population in need of a medicines reduces the
need for even greater retail, country-by-country work.

I wouldn¹t want to have to rely on a single strategy alone, unless we
somehow can win a no-IP on medical technologies demand, something that
needs to be promoted at the UN Secretary=General¹s High Level Panel on
Access to Medicines.

Professor Brook K. Baker
Northeastern University School of Law
416 Huntington Ave.
Boston, MA 02115
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu
Skype:  brook_baker

On 3/8/16, 11:25 AM, "Ip-health on behalf of Tahir Amin"
<ip-health-bounces at lists.keionline.org on behalf of tahir at i-mak.org> wrote:

>If true, how does this now work vis VLs. Are VL's still complementary?
>On 8 March 2016 at 09:14, Andrew S. Goldman <andrew.goldman at keionline.org>
>> http://in.reuters.com/article/india-patents-usa-idINKCN0WA18Q
>> U.S. industry body says India agreed to not issue 'compulsory' drug
>> licences
>> India has given private assurances that it will not grant licences
>> local firms to override patents and make cheap copies of drugs by big
>> Western drugmakers, a U.S. business advocacy group said.
>> The comments were revealed in a submission last month by the U.S.-India
>> Business Council (USIBC) to the U.S. Trade Representative (USTR), which
>> reviewing global intellectual property laws for an annual report
>> identifying trade barriers to U.S. companies.
>> The USTR has placed India on its "priority watch" list for two years in
>> row saying the country's patent laws unfairly favour local drug makers.
>> bone of contention has been a legal provision that allows the
>>overriding of
>> patents on original drugs and granting of 'compulsory licences' to local
>> firms to make cheaper copycat medicines.
>> India can grant such licences under certain conditions, such as public
>> health emergencies, to ensure access to affordable medicines for its
>> poor people. It granted the first such licence in 2012, allowing local
>> Natco Ltd to sell a copy of German drugmaker Bayer's cancer medicine
>> Nexavar at a tenth of the price.
>> Since that ruling, big Western pharmaceutical companies have criticised
>> India's patent law and lobbied for it to be changed.
>> In its submission to the USTR, a copy of which was seen by Reuters, the
>> USIBC said the government "privately reassured" the group that it would
>> grant such licences to firms for commercial purposes.
>> The government has made no such statements publicly. Officials have said
>> they are committed to protecting the interests of patients.
>> Commerce Minister Nirmala Sitharaman, her joint secretary in charge of
>> pharmaceuticals, and the USIBC did not respond to requests for comment.
>> Washington-based non-profit Knowledge Ecology International (KEI)
>> concern over the USIBC submission.
>> "If such an agreement in fact exists, this is extremely troubling news
>> this sort of pressure is basically a declaration of war on poor cancer
>> patients," KEI said in its own submission to the USTR last week. It
>> for details of the agreement to be made public.
>> Under Prime Minister Narendra Modi, India has been undertaking a review
>> its intellectual property (IP) policy. A revised policy is due to be
>> released imminently.
>> Several health activists and charities like Medecins Sans Frontieres
>> criticised the review, saying India is buckling under U.S. pressure and
>> compromising the interests of patients.
>> The U.S. Chamber of Commerce and the Pharmaceutical Research and
>> Manufacturers of America, the biggest U.S. industry lobby group, have
>> recommended keeping India on the U.S. "priority watch" list in separate
>> submissions to the USTR.
>> The Indian Pharmaceutical Alliance, which represents 20 big drug makers,
>> argued in its own submission that India's patent laws were fully
>> WTO-compliant. Its head chided the USIBC for breaching confidence in its
>> submission.
>> "If the government of India had said something privately, USIBC should
>> have embarrassed it by making it public," said Secretary General D.G.
>> (Reporting by Zeba Siddiqui)
>> --
>> Andrew S. Goldman
>> Counsel, Policy and Legal Affairs
>> Knowledge Ecology International
>> andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
>> tel.: +1.202.332.2670
>> www.keionline.org
>> _______________________________________________
>> Ip-health mailing list
>> Ip-health at lists.keionline.org
>Tahir Amin
>Co-Founder and Director of Intellectual Property
>Initiative for Medicines, Access & Knowledge (I-MAK)
>*Website:* www.i-mak.org
>*Email:* tahir at i-mak.org
>*Skype: *tahirmamin
>*Tel:* +1 917 455 6601/+44 771 853 9472
>Ip-health mailing list
>Ip-health at lists.keionline.org

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