Merk(el)ing Around

A careful reading of the past can open the doors to a better future. The German Chancellor Ms. Angela Merkel is on an India tour and is pushing forth for the EU – India Trade Agreement also known as Broad based Trade and Investment Agreement (BITA). The talks for BITA have been on the cards since 2007 but there has been no conclusive agreement that has been signed between EU and India. Earlier this year, the Indian government had cancelled on the BITA due to a ban imposed on 700 (almost) Indian generics by the EU based on the recommendation of European Medication Agency (EMA)[1].

In January 2015, the EMA had issued its recommendation to impose a ban on certain generic drugs being imported from India; a re-examination of the bio-equivalence testing was conducted after the request of marketing authorities of some of the medicines being banned. The result of the re-examination also concluded that there had been certain data manipulation with regard to the generics, for instance, the Electrocardiogram (ECG) had revealed certain manipulation according to the report submitted by French Medicines Agency (ANSM). It was stated that due to the anomalies of the clinical studies made available, on the generics (by Indian companies), a ban was recommended. It was categorically stated that there was no harm or lack of effectiveness reported in these drugs and the same could be made available in certain countries where there was a requirement of patients in that country.  The importance of a bio-equivalence testing cannot be ignored; it is the usual practice to examine the quality of the generic drugs being imported in to a country. It is an essential requirement for a country to examine the drugs to ensure that quality drugs are made available to the citizens, a high level of precaution is observed in case of drugs because a minor miscalculation could turn out to as life threatening. While the EU was acting according to its usual policy of examining the drugs, the ban did not go down very well with the Indian government and it called off the trade negotiations in August. The officials of the generic drugs stated that their clinical practices confirmed with the FDA requirements (USA) when it had been examined; this claim was later supported by the FDA as well[2]. However, it is possible that each country/region sets up its own procedure to determine good clinical trial before approving the generics. A red flag can be raised only when there has been any evidence of discrimination between generics of one country and other as the same would be a violation of Most Favored Nation clause in the WTO.

It has been estimated that this ban could cost India a loss of $1-1.2 billion worth of drug exports[3], in the year 2014-15 the net worth of drugs export from India to EU was said to be close to $3 billion and the generics itself accounted for $1 billion[4]. The suspension of these generics for a period of two years will be a great loss of revenue for the Indian government and hence, a major cause of concern and discussion between EU and India. The German Chancellor is now hoping that there can be an amicable solution to this concern raised by India while the generic industry in India is hoping that the Indian government sticks to the stance of defending them. The issue at hand is a dicey one as one cannot exactly condemn the EU’s practice of requiring good clinical trial, it will be interesting to see how the same gets resorted.

It is important for the Indian government to act now since, a lot of regional pacts are in midst of or already have been drawn up, for instance, the Transatlantic Trade and Investment Partnership (between the EU and U.S.), and the Trans Pacific Partnership (between 12 countries). In the wake of these developments it is imminent that the Indian government enters into an agreement with the EU without much delay since it is one the largest trading partners for the country[5]. It is of course, necessary that there should be no hasty decisions made that would compromise with the generic industry prevailing in India (the prevalence of generics ensure that certain drugs are affordable to an average Indian.) In the coming few days it will be apparent whether the issues raised in the past between EU and India will be resolved in an amicable fashion. I will update this space very soon!

Footnotes:

[1] Ema.europa.eu, (2015). European Medicines Agency – News and Events – GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies. [online] Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/05/news_detail_002338.jsp&mid=WC0b01ac058004d5c1  [Accessed 6 Oct. 2015].

[2] Silverman, E. (2015). European Union Bans Hundreds of Drugs Over Clinical Trial Studies. [online] WSJ. Available at: http://blogs.wsj.com/pharmalot/2015/07/27/european-union-upholds-ema-recommendation-to-ban-hundreds-of-drugs/ [Accessed 6 Oct. 2015].

[3] Vijayakumar, S. (2015). Ban on Indian drugs based on scientific reasons: EU. [online] The Hindu. Available at: http://www.thehindu.com/business/ban-on-indian-drugs-based-on-scientific-reasons-eu/article7508551.ece  [Accessed 6 Oct. 2015].

[4] Krishnan, V. (2015). India cancels trade talks after Europe bans 700 generic drugs. [online] The BMJ. Available at: http://www.bmj.com/content/351/bmj.h4387  [Accessed 6 Oct. 2015].

[5] Sasi, A. (2015), India –EU Trade Pact: Antibiotic for Common Cold. [online] The Indian Express, Available at: http://indianexpress.com/article/india/india-others/india-eu-trade-pact-antibiotic-for-common-cold/ [Accessed 6 Oct. 2015].

Sorting out the (TPP) Differences

It has been reported that the TPP Agreement will be drawn up very soon.Popcorn Law India has covered the potential concerns raised by TPP Agreement in the posts here, and here.  The TPP Agreement is one of the strategic political tools to offset China’s powerful influence in the region, it seeks to come up with stringent IP enforcement regulations which otherwise might not be acceptable to Asia’s big powerhouses –China and India, but due to the neighboring countries entering into the agreement some pressure can be put on these two countries as well. The TPP has been in the news due to the high level of secrecy maintained by the member countries and the controversial provisions, which have come under fire, leaked by wikileaks and KEI.

It has recently been reported that apparently not all member nations are very satisfied with some of the key reforms intended to be pushed through the TPP. Australia has witnessed protests and disagreements relating to extending the data exclusivity period from the five year period to at least eight years ( earlier the demand was to extend to a period of 12 years), the reason being that further extension of data exclusivity will result in further delaying the entry of generics in the market, people will continue to pay a higher price for the medicine for an additional period of at least three years. If seen from the view of the Australian government it is indeed a valid concern because the accessibility and affordability of medicines heavily depends on their prices which in turn is directly connected with their patent/data exclusivity protection term and the higher the price the lesser the probability of drug being available to all classes of people. Interestingly, neighbor New Zealand too also permits five years for data exclusivity while member countries like Peru, Chile, Malaysia, and Brunei till now did not provide for data exclusivity and are willing to extend it to five years alone.

The U.S. representatives have been pushing for a 12 year protection for biologics data exclusivity since it is in consonance with the U.S. law. On the other hand the Australian Prime Minister has been under the pressure of not caving into the U.S. demands for increasing the term of protection[1].  The governments of all the member countries have been under immense pressure due to the probable consequences of the TPP Agreement, it is due to this reason that Canada’s New Democratic Party Leader Tom Muclair has stated in a letter to the current Trade Minister that if elected his party will not be bound by the TPP[2].  With the claims that a final agreement has been drawn up, a lot of speculation will come to an end and there will be a credible document based on which valid legal concerns can be raised.

Image from here.

Footnotes

[1] Financial Review, (2015). US, Australia drug dispute is holding up settlement of the Trans Pacific Trade Deal. [online] Available at: http://www.afr.com/news/politics/national/us-australia-drug-dispute-is-holding-up-settlement-of-the-trans-pacific-trade-deal-20151003-gk0r65  [Accessed 5 Oct. 2015].

[2] Wingrove, J. (2015). Mulcair Says Canada NDP Not Bound by TPP Deal If Elected. [online] Bloomberg.com. Available at: http://www.bloomberg.com/news/articles/2015-10-02/mulcair-says-canada-ndp-won-t-be-bound-by-tpp-deal-if-elected-ifa4c6zz  [Accessed 5 Oct. 2015].

Gandhi’s brush with Copyright

Today is Gandhi Jayanti [Birthday of Mahatma Gandhi] and this post is dedicated to the great man who played a major role in India’s independence. Gandhi, was an avid writer and frequently communicated with the public through his writings -it was his medium to reach out to people whom he could never meet, a medium to express his true feelings about the independence movement, caste system, and prejudices in the society. After his death his writings form a major part of his legacy, they have immortalised his principles and allows the new generations to get an insight about the times and circumstances that prevailed at the time of his writings and his views on certain integral issues. His writings are a narrative (seen from his view) of India’s history and also a Copyright concern -yes, its an IP law blog, can not help but drag it in here as well.

Earlier this year I had read a very interesting and informative article titled as Gandhi’s Copyright Pragmatism by Shyamakrishna Balganesh and it can be read here ,this article is a revelation about Gandhi’s views on Copyright laws, which is very rarely known or read and I would request the readers to read it to know more about the man.

In January 2009 the copyright over Gandhi’s works ended and despite certain groups demanding an extension for copyright protection of his works the Navjivan Trust, that had been publishing his works since 1913, made no such attempt to extend copyright for his works. It was reasoned by Amrut Modi, Secretary of Sabarmati Ashram Preservation and Memorial Trust, that Gandhi himself did not believe in the concept of a personal inheritance and himself was not very keen on copyright over his works.[1] In his article Shyamakrishna Balaganesh delved into this aspect and has stated that Gandhi was not entirely against the institution of Copyright laws as is often projected, Gandhi believed in Jeremy Bentham’s concept of utilitarianism i.e. greatest good of all and due to this reason initially, in his works, he did not assert his copyright therefore, making his works freely accessible and freely published all across the globe. It is quite obvious that the primary intent for doing so was free dissemination of knowledge and his views to the people (even if they could not meet him). However, this backfired at some point when his views and ideas in his works were represented in a distorted fashion and often inconsistent with the original context in which a particular excerpt had been written, this resulted in creating misunderstandings among people in India. It was at this time that he realized the importance of copyright laws particularly, as a means to acknowledge the author of a work and to assert moral rights over the work [S.57 of the Indian Copyright Act, 1957 serves this purpose] to prevent it from being distorted and misrepresented[2].Gandhi truly believed that knowledge was not something that could be compared with money –knowledge was the tool for empowerment and development of a nation [3].The economic aspect of copyright laws posed lesser of a concern to him and as has been mentioned earlier it was not in consonance with his utilitarian approach. The following is an excerpt from his compiled work:

“Writings in the journals which I have the privilege of editing must be the common man’s property. Copyright is not a natural thing. It is a modern institution, perhaps desirable to a certain extent…”[4]

The Navjivan trust in 2009 acted aptly by refusing to make an attempt at extending the copyright of his works because the same would mean that the works would still be withheld from being freely accessible and available to people. More publishing houses can now publish his works and while they earn profits from the same they also spread his message to humanity. In the modern context his approach to Copyright laws is quite similar to the principle that is currently followed by the Creative-Commons where moral rights are given a precedence over economic right by making the works freely available to all.

It is almost 67 years since Gandhi has passed away and till date his works are revered as works which narrate the power of non-violence, and peace over aggression and brutality; it narrates the story of how a frail old man from India lead the Indian independence movement and inspired leaders like Nelson Mandela to follow the same path to gain independence. So, maybe this Gandhi Jayanti you could buy his autobiography [My Experiments with Truth] and read more about him (you may choose to agree or disagree with him) or revisit his works.

Gandhi Cartoon Image from here.

Footnotes

[1] Rautela, Vikram. ‘Now, Copyright Of Mahatma Gandhi’s Writings Belongs To People – Indian Express’. Archive.indianexpress.com. N.p., 2009. Web. 1 Oct. 2015.

[2] Balganesh, S. (2013). Gandhi and Copyright Pragmatism. California Law Review, 101, pp.1705-1762.

[3] Ibid.

[4] Archive.deccanherald.com,. ‘Deccan Herald -No Copyright: Who Will Preserve Gandhi Works?’. N.p., 2009. Web. 1 Oct. 2015.

Of India’s (IP) concerns with U.S.

On 22^nd September, the Center for Internet and Society (CIS) India wrote an open letter to Prime Minister to look into certain IP law related concerns for India ahead of the U.S. – India talks this week (ongoing). There were two major IP issues addressed:

1. The U.S. should ratify the Marrakesh Treaty for visually impaired persons; and
2. The Indian government should not enter into the Trans Pacific Partnership Negotiations (TPP).

Marrakesh Treaty

India is a signatory to the Marrakesh Treaty which calls for a balance between Copyright Laws and Limitations, Exceptions for People with Visual and Print Disability. The Indian Copyright Amendments, 2012  also witnessed the inclusion of an exception for reproducing published works into Braille for the convenience of such visually disabled individuals. The World Blind Union had earlier released[1]in its ‘Right to Read’ Campaign that almost 90% of all the published works was inaccessible to the visually impaired individuals, and the same has been cited by the CIS in its letter.[2] India’s Copyright Amendment 2012 allows room for compulsory licensing of works for the use of visually impaired individuals (prior to Marrakesh Treaty it had been introduced in India.) The Marrakesh Treaty can come into effect only after 20 countries ratify it; currently the number is stuck at 9 countries which does not include the U.S. The letter requests that the U.S. should also sign the treaty since it is home to some of the largest publishing houses and would encourage a proper implementation –of the treaty and India’s new amendment.

Trans Pacific Partnership

The TPP is undoubtedly one of the most controversial regional agreements in the current times. It has included provisions which call stringent IP laws leaving lesser rooms for exceptions and limitations and stand to the benefit of mostly U.S. based authors, Entertainment Industry and dangerously their pharmaceuticals. The TPP discussions have been very cryptic till date and hence, raised the bar for suspicion. Member countries like Australia and New Zealand have faced protests by citizens against adopting TPP provisions which hamper public health and are solely lead by the U.S. (for its Corporate houses)[3]. The CIS letter raises concerns about the U.S. making an attempt at including India in the TPP Agreement, it also makes a reference to the report of Hon’ble Ambassador Shri Arun  K. Singh where he has disagreed with the U.S. report suggesting TPP is beneficial for India and U.S. both (clearly the benefit is unilateral). India is currently in the stage of using and developing technology and cannot afford to lose out on limitations and exceptions of IP enforcement. Also, it is necessary to reiterate that India is currently the largest manufacturer of generics and compliance with U.S. dominated patent laws will inadvertently hit the pharma generics really hard. The letter simply requests the PM not to accede to the U.S. intent of making India a party to the TPP.

On a slightly different note it is interesting to note that owing to the high price of  cancer drugs in the U.S. ,at the time when they are close to losing patent protection, has lead to the U.S. government looking for alternatives. In a recent article it has been stated that New Delhi will be providing cheaper ‘off-patent’ drugs to the U.S. to benefit the American citizens.[4] It will be interesting to see how the U.S. intends to continue with its stringent Patent enforcement regime even in the future when it is clearly beginning to affect the public health concerns (affordability and accessibility).

It can be stated that the CIS has pointed out two major IP issues that the government needs to be aware of at the time when it is negotiating with the U.S. for better bilateral relations (inevitably dealing with IP issues as well). It is worth looking out for how the negotiations pan out!

Image Courtesy: http://www.bilaterals.org/?leaked-investment-chapter-of-the 

Footnotes

[1] Worldblindunion.org,. ‘Marrakesh Treaty – Right To Read Campaign’. Web. 26 Sept. 2015.

[2] Prakash, Pranesh. ‘Open Letter To PM Modi On Intellectual Property Rights Issues On His Visit To The United States Of America In September, 2015’. The Centre for Internet and Society. N.p., 2015. Web. 26 Sept. 2015.

[3] It’s Our Future,. ‘It’s Our Future – Kiwi Voices On The TPPA’. N.p., 2015. Web. 26 Sept. 2015.

[4] Rajghatta, Chidanand. ‘India To Supply Generic Cancer Drug To U.S.’. Times of India. N.p., 2015. Web. 26 Sept. 2015.