Tag Archives: PAE

“India is The Biggest Battlefield for Intellectual Property Rights”

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The US Senator Orrin Hatch reportedly made the above comment while introducing the 2014 report on ‘International Intellectual Property (IP) Index’, prepared by an Israel based consultancy firm – Pugatch Consilium for the Global Intellectual Property Centre (GIPC) of the US Chamber of Commerce. In this forum, the Senator further alleged, “India misuses its own IP system to boost its domestic industries”.

Similar comment on South African IP Policy:

It is interesting to note that this ‘Battle Cry’ on IPR follows almost similar belligerent utterance of a Washington DC-based lobbying firm named ‘Public Affairs Engagement (PAE)’, reportedly headed by a former US ambassador Mr. James Glassman.

PAE, in a recent South African IP policy related context, as deliberated in my earlier blog titled, “Big Pharma’s Satanic Plot is Genocide”: South Africa Roars”, had stated in January 2014, “Without a vigorous campaign, opponents of strong IP will prevail, not just in South Africa, but eventually in much of the rest of the developing world.”

The GIPC report:

That said, in the GIPC report, India featured at the bottom of 25 countries on Intellectual Property (IP) protection with a score of 6.95 out of 30. Thailand, Vietnam, Indonesia and Argentina also scored low in overall ranking on protection for patents, copyright and trademarks. The United States ranked at the top, followed closely by Britain and France.

Interestingly, no country could register a “perfect” score in the survey, which used 30 factors ranging from levels of counterfeiting and piracy to patents and legal protections for all kinds of products and services ranging from pharmaceuticals to software to Hollywood films.

Among other BRIC countries, Russia with a score of 13.28, China with 11.62 and Brazil with 10.83, ranked 13th, 17th and 19th, respectively, within the selected 25 countries.

Key reasons, especially related to pharmaceuticals, as cited for the poor rating of India are as follows:

  • “Patentability requirements in violations of TRIPS”
  • “Regulatory Data Protection (RDP) not available”
  • “Patent term restoration not available”
  • “Use of Compulsory Licensing (CL) for commercial non-emergency situation”

The ground reality in India:

The answers to all these questions are much discussed and now an integral part of Indian Patents Act, as enacted by the Parliament of the country after prolong deliberations by the astute lawmakers keeping patients’ interest at the center.

As I had indicated earlier, there does not seem to be any possibility of these laws getting amended now or in foreseeable future, despite the above ‘Battle Cry’, Special 301 Watch List of the US, and continuous poor rating by the US Chamber of Commerce. This is mainly because of humanitarian sentiments attached to this issue, which are robust and sensitive enough to ignore even politically in India. Let me try to address all these 4 points briefly as follows:

“Patentability requirements in violations of TRIPS”:

Patentability is related mainly to Section 3(d) of the Patents Act. India has time and again reiterated that this provision is TRIPS compliant. If there are still strong disagreements in the developed world, the Dispute Settlement Body of the ‘World Trade Organization (WTO)’can be approached for a resolution, as the WTO has clearly articulated as follows:

“WTO members have agreed that if they believe fellow-members are violating trade rules, they will use the multilateral system of settling disputes instead of taking action unilaterally. That means abiding by the agreed procedures, and respecting judgments. A dispute arises when one country adopts a trade policy measure or takes some action that one or more fellow-WTO members considers to be breaking the WTO agreements, or to be a failure to live up to obligations.”

Thus, it is quite challenging to fathom, why those countries, instead of creating so much of hullabaloo, are not following the above approach in the WTO for the so called ‘patentability’ issue in India?

“Regulatory Data Protection (RDP) not available”:

In this context, Commerce and Industry Minister Anand Sharma had reportedly asserted earlier at a meeting of consultative committee of the Parliament as follows:

“India does not provide data exclusivity for pharmaceuticals and agro-chemicals which is in the paramount interest of our generic pharmaceutical industry as grant of data exclusivity would have considerable impact in delaying the entry into the market of cheaper generic drugs.”

Hence, the question of having RDP in India does not possibly arise, at least, in near to mid term, which would require moving an amendment in the relevant Act through the Parliament.

“Patent term restoration not available”:

Again, this provision does not exist in the Indian Patents Act. Hence, in this case too, a change does not seem likely, at least, in near to mid term, by bringing an amendment through the Parliament.

“Use of Compulsory Licensing (CL) for commercial non-emergency situation”:

Besides situations like, national emergency or extreme urgency, the current CL provisions, as per the Indian Patents Act, specifically state that at any time after the expiration of three years from the grant of patent, any interested person may make an application to the Patent Controller for grant of patent on the following grounds:

  • Whether the reasonable requirements of the public with respect to the patented invention have been satisfied?
  • Whether the patented invention is available to the public at a reasonable affordable price?
  • Whether the patented invention is worked in the territory of India?

It is worth mentioning, the Government has no authority to direct any individual for not applying for any CL under the above provision of the statute, hence law will take its own course in this area too, unless an amendment through Parliament is made in the Patents Act, which seems very unlikely again in the near to medium term.

Eyebrows raised on methodology and motive behind the ‘IP Index’ report:

Media report indicates that IP experts in India have questioned the methodology and even the motive behind GIPC’s ‘International Intellectual Property (IP) Index’ where India has been ranked the lowest among 25 countries.

The same article quotes a well-known IP expert saying, “Underlying this report is a major paradox that protecting weak patents makes the IP regime a strong one. Countries such as India that have stood up for genuine innovation and refused to protect trivial inventions have been accused of having ‘weak’ IP regimes, while it should have been the other way round.”

The article also mentions that Pugatch Consilium, which provides advisory services to top global drug makers and their trade associations, drafted the report for the US Chamber of Commerce.

Conclusion:

Keeping aside the strong allegation that the GIPC report has some ulterior motive behind, the high profile PR blitzkrieg of the pharma multinational trade associations, quite in tandem with South African outburst on the same IP issue, as I wrote in my blog post “Big Pharma’s Satanic Plot is Genocide”: South Africa Roars”, is indeed noteworthy.

However, even if one goes purely by the merits of the report with GIPC’s reasoning on ‘Why is India losing ground’, I reckon, despite so much of cost-intensive efforts and pressures by the global pharma lobbying groups, their expectation for a change in the pharma patents regime in India, any time soon, is probably much more than just a wishful thinking.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Pharma MNCs Jettison Lobbyist’s Plan: A Welcoming Development?

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In my just previous blog post titled, “Big Pharma’s Satanic Plot is Genocide”: South Africa Roars, I quoted a recent interview of the Health Minister of South Africa (SA) Mr. Aaron Motsoaledi on the above plan.

As reported in the interview and also indicated in an article in my blog, the Trade and Industry Department of SA, on September 4, 2013, published a long-awaited draft national policy on Intellectual Property (IP) in the Government Gazette.

Flabbergasted by the content of the draft policy, as the article indicates, pharma MNCs having operations in South Africa, almost immediately, started working on a plan through their trade association to surreptitiously change the direction of the above draft policy, radically. Instead of optimal protection for drug patents, the lobbyist reportedly planned to seek much stronger protection. 

Hatching a plan:

The report highlights, Virginia-based US lobbying firm ‘Public Affairs Engagement (PAE)’ accordingly prepared a blueprint titled, “Campaign to Prevent Damage to Innovation from the Proposed National IP Policy in South Africa” for the local trade body ‘Innovative Pharmaceutical Association of South Africa (IPASA)’. The PAE plan reportedly highlighted that, “South Africa is now Ground Zero for the debate on the value of strong IP protection. If the battle is lost here, the effects will resonate.” 

The document, according to the above report, was circulated to IPASA member companies on January 10, 2014, proposing the work to be conducted on the campaign from January 13 to February 15, the details of which I had penned in my previous blog post.

Fortunately, the grand strategy was leaked out and “South African Mail & Guardian Newspaper” published details of the game plan, which was consequently condemned with strong words by the health activists, across the world.

Pharma MNCs jettison lobbyist’s strategy:

It has now been reportedly confirmed that PAE did submit a proposal, against South African Government’s proposed draft patent policy, to IPASA. However, following a global furore on this development, as reported on January 20, 2014, the pharma MNCs operating in South Africa have since rejected the planned campaign and no payment or pledge has been made to the US based lobbyist. South Africa’s Health Minister had earlier warned that the said campaign would lead to “genocide.” 

Conclusion:

It is good to know that the local trade association of South Africa, as the external pressure started snowballing, has now articulated that, “It supports the broad objectives of the draft national IP policy…A number of the health-related recommendations outlined in the draft policy, including mechanisms for compulsory and voluntary licensing and parallel importation are already possible through existing legislation”.

Be that as it may, isn’t the decision of pharma MNCs to jettisoning the grand plan proposed by the lobby group against South African Intellectual Property (IP) related draft policy a pragmatic and welcoming one?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion

“Big Pharma’s Satanic Plot is Genocide”: South Africa Roars

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In a recent interview, the Health Minister of South Africa (SA) Mr. Aaron Motsoaledi reportedly made the above comment.

The background:

As reported in the interview and also indicated in an article in this blog, the Trade and Industry Department of SA, on September 4, 2013, published a long-awaited draft national policy on Intellectual Property (IP) in the Government Gazette. In that draft policy, the department recommended, besides others, the following:

  • Provision should be made for the Compulsory Licensing (CL) of crucial drugs.
  • Provision should be made for the parallel importation of drugs.
  • Grant of drug patents should ensure that the drug is new or innovative.
  • “Patent flexibility” for medicine should be made a matter of law.
  • The holders of Intellectual Property Rights (IPR), such as drug companies, should be encouraged to protect their own rights rather than depending on state institutions, such as the police or customs.
  • SA should seek to influence the region, and the world, to move towards its vision of Intellectual Property (IP) protection.

The draft does not have the status of a policy, as yet, and was open for public comment.

Pharma MNC moved surreptitiously: 

Pharma MNCs having local operations being flabbergasted by this development, almost immediately, started working on a plan to change the direction of the policy radically, the report states. Instead of optimal protection for drug patents, they planned to seek stronger protection. 

Having finalized the counter strategy this month, the local MNC pharma association, ‘Innovative Pharmaceutical Association of South Africa (Ipasa)’, reportedly selected a Washington DC-based lobbying firm ‘Public Affairs Engagement (PAE)’, headed by a former US ambassador – Mr. James Glassman, to lead the charge against the policy. PAE, by now, has put forward a proposal on how it would effect radical changes to the policy, the report stated.

The same article mentions, PAE intends to launch a persuasive campaign throughout Africa and in Europe with an aim to convince the South African Government to further strengthen, rather than weaken, patent protection for drugs. The grand plan of PAE contains elements, which could seriously bother many right thinking individuals, as it includes:

  • Setting up a “coalition” with an innocuous name such as “Forward South Africa (FSA)”, which will be directed from Washington DC, while appearing to be locally run in SA.
  • Encouraging other African countries, especially Rwanda and Tanzania, to help convincing SA that it could lose its leadership role in the continent, if it decides to push ahead with the draft policy.
  • Distracting NGOs from their own lobbying by changing the nature of the debate.
  • Commissioning seemingly “independent” research and opinion pieces for broad public dissemination – but vetting all such material before publication to ensure those fit the messages. 

Creation of surrogate public faces:

It is worth noting from the report that the so called coalition ‘FSA’, the proposed public face of the campaign, would be “led by a visible South African, most likely a respected former government official, business leader or academic”. However, at the same time, it would be “directed by staff from PAE and its South African partner”.

Majority funding by an American association in SA:

The report also highlights, nothing in the document suggests that the funding for FSA – estimated at  mind-boggling numbers of U$ 100,000 from IPASA and another US$ 450,000 from an ‘American Association’ of pharmaceutical companies – would be disclosed.

The report concluded by quoting the American lobbyists hired to launch a counter campaign, which states, “Without a vigorous campaign, opponents of strong IP will prevail, not just in South Africa, but eventually in much of the rest of the developing world.”

This is not a solitary example:

The Guardian reported another such incident in July 2013. The article stated that the global pharmaceutical industry has “mobilized” an army of patient groups to lobby against the plan of European Medicines Agency (EMA) to force pharma companies to publish all Clinical Trial (CT) results in a public database for patients’ interest.

While some pharma players agreed to share the CT data as required, important global industry associations strongly resisted to this plan. The report indicated that a leaked letter from two large pharma trade associations, the Pharmaceutical Research and Manufacturers of America (PhRMA) of the United States and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have drawn out a strategy to combat this move.

The strategy reportedly demonstrates, as the article highlights, how have the Big Pharma associations drawn the patient groups, many of which receive funding from drugs companies, into this battle.

Conclusion: 

As I had articulated several times in the past, newer innovative drugs are extremely important in the fight against diseases and this flow must continue, actively supported by a well-balanced Patents Act of the country, as India has already implemented.

That said, the moot question continues to remain, who are these innovations and innovative medicines for? Are these to save precious lives of only a small minority of affluent nations, their populations and other wealthy people elsewhere, depriving a vast majority, across the world, of the fruits of innovation? Would repeated harping on the much hyped phrase, “meeting unmet needs of patients”, negate such gross indifference?

If that is the case, it becomes the responsibility of a Government, keeping the civil society on board, to formulate effective remedial legal measures. The draft national policy on ‘Intellectual Property’ of SA is one such initiative that needs to be applauded.

Surreptitious reported attempts of pharma MNCs, repeatedly, through their respective associations, backed by bagful of ‘resources’ of all kinds to thwart such patient centric moves of Governments, should be deplored with contempt that they deserve.

As Indian scenario is no different, it would perhaps be good to fathom, whether similar surreptitious and high resource-intensives moves are in progress in this country as well.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.