The European Union (EU) Parliament’s July 4 vote against the ratification of the Anti-Counterfeiting Trade Agreement (ACTA) had organisations like Médecins Sans Frontières celebrating the ‘death of ACTA’. But any illusion that this experience will force the EU Parliament to give India and other countries some leeway in other similar discussions, like the free trade negotiations (FTAs) being pursued by the European Commissioner (EC), is just that … an illusion.
 “I do not think that it (rejection of ACTA by EU Parliament) would lead to any softening of the EC’s negotiating position in the EU-India FTA.”D G Shah, Secretary General, IPA |
As DG Shah, Secretary General, Indian Pharmaceutical Association, cautions, “Many who voted against the ACTA also stressed the need to find alternative ways to protect intellectual property in the EU. I therefore do not think that it would lead to any softening of the EC’s negotiating position in the EU-India FTA.”
Shah’s Association represents many big Indian pharma companies, some of who have seen their consignments of generic medicines grounded at ports in the EU. These EU countries seized these generic medicines for ‘trademark violations’ of patented drugs even though these generics were recognised in the destination countries like Africa and Latin America.
 “It’s a great relief from the attempts of vested interests to show that legitimate generics are of substandard quality.”Dr P V Appaji Director General, Pharmexcil |
Dr PV Appaji, Director General, Pharmexcil comments that the EU Parliament’s decision has come as a “great relief from the attempts of vested interests to show that legitimate generics are substandard quality.”
 “The agreement has not been formally approved by any of the signatory countries, as yet though it now appears that it will not be will not be applicable to EU.”Tapan Ray, Director General, OPPI |
Tapan Ray, Director General, Organisation of Pharmaceutical Producers of India (OPPI), points out that the agreement has not been formally approved by any of the signatory countries, as yet though it now appears that it will not be applicable to EU. The rejection in the EU is therefore not expected to reverse the other countries’ support for ACTA.
 “ACTA is clearly superfluous and unnecessary as it attempts to create an additional framework that brings no value to the system.”Prof Prabuddha Ganguli CEO, VISION-IPR, Mumbai and MHRD IPR Chair Professor, Tezpur University, Assam |
Proponents of ACTA warn that the EU’s Parliament rejection of ACTA dilute IPR protection in the EU but IPR experts like Professor Prabuddha Ganguli, CEO, VISION-IPR, Mumbai and MHRD IPR Chair Professor, Tezpur University, Assam rubbish this claim.
He feels that ACTA is “clearly superfluous and unnecessary as it attempts to creates a additional framework that brings no value to the system” and the rejection of ACTA in no way dilutes EU’s strong intention to enforce IPR in its members. Ganguli opines that the TRIPS Agreement in Article 51 read with Footnote 14 adequately addresses issues related to measures against “anti-counterfeit” and further jurisdiction specific enforcement of patent rights, trademark rights and copyright are addressed within the framework of the IPR laws including civil and criminal procedures in each country.
More IP hurdles ahead
There has been a long history of push back. For instance, one of the earliest well-organised attempts to discredit off-patent medicines was the launch of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) by the WHO in 2006. WHO was forced to water down its role in IMPACT after there were clashes between member countries at the both the 2008 and 2010 World Health Assemblies. WHO member countries from the developing world criticised WHO’s role in IMPACT as well attempts use the word “counterfeit” as a public health term. The argument was that counterfeit matters should be handled by WTO and WIPO and not the WHO.
A Third World Network report on the WHA 2010 proceedings featured a very telling reaction from WHO Director-General Dr Margaret Chan, who reacted to this tussle clarifying that WHO would focus on public health problems, and confirmed that the WHO had no role to play in IPR enforcement. She spoke of the need to take a multi-disciplinary and multi-faceted approach but only on the public health aspect and not on law enforcement or IP enforcement. Commenting on the perception that WHO was waging a war on generic medicines she said that if there is anything that WHO is doing to attack genuine, quality, generic medicines, “I will punish those staff”.
Added to this alphabet soup are the Patent Law Treaty (PLT) and Substantive Patent Law Treaty (SPLT) in the WIPO; and the Trans-Pacific Partnership (TPP) Agreement.
The Patent Law Treaty (PLT) concluded on June 1, 2000 and Substantive Patent Law Treaty (SPLT) in the WIPO aims at going far beyond the formalities of the PLT to harmonise substantive requirements such as novelty, inventive step and non-obviousness, industrial applicability and utility, as well as sufficient disclosure, unity of invention, or claim drafting and interpretation.
The TPP threat
 “TPP is more expansive than ACTA and potentially far more destructive.”Swaraj Paul Barooah IP Scholar, UC Berkeley’s Law School |
Indeed, the next immediate threat on the horizon is thought to be the TPP, which “is more expansive than ACTA and potentially far more destructive,” opines Swaraj Paul Barooah, IP Scholar at UC Berkeley’s Law School in his blog post titled ‘Exit ACTA, Enter TPP’ on SpicyIP.
As Barooah explains in this blog post, TPP is ostensibly a free trade agreement (FTA) that the US is negotiating with eight other nations (Australia, Peru, Malaysia, Vietnam, New Zealand, Chile, Singapore and Brunei); Mexico and Canada have also been invited to join in and Japan is expected to join in as well.
He points out that the ‘secretive’ negotiations have been going on since 2009 and are expected to be complete by the end of 2012.
Based on leaked drafts and documents, Barooah lists out five primary areas of concern in the TPP. While the lack of transparency is common to the early days of ACTA, TPP seems to propose extra-judicial enforcement, in that the dispute resolution process sets up an international tribunal which seems to circumvent domestic judicial systems. Barooah comments that it also seems to be very MNC friendly, granting them power to challenge countries’ laws, regulations and court decisions in this international tribunal.
Thirdly, Barooah opines that the TPP makes corporate responsibility “a joke” as it obliges member countries to provide a host of extreme new privileges (taking some of the worst aspects of NAFTA) while there are no general exceptions to safeguard environmental, health, labour or consumer protection policies.
Specific to the pharma industry, the proposals on pharma pricing include introducing new administrative and judicial appeal systems to ensure that governments are ‘properly valuing’ drug patents when they buy them for their public health programmes. The attempt is to bring in provisions which allow pharma companies to sell en masse to governments while also raising the prices.
And Barooah’s fifth point is on the IP front, where he says that the TPP seems more restrictive than ACTA because all signatory countries will have to bring their domestic laws in line with the IP provisions laid out in TPP. Some of the problematic IP proposals are that temporary reproductions, which could include digital copies of nearly anything online, are included as copyright infringement.
TPP also proposes to further extend the copyright period making the minimum duration for corporate owned works-for-hire as 95 years, +70 years for the standard copyright protection and 120 years for unpublished works.
Regardless of copyright violation, the TPP proposes anti-circumvention provisions so that even after an extended copyright protection period, one can continue to ‘protect’ work simply by attaching a technological protection measure (TPM). The TPP also provides for TRIPS plus damages for copyright infringement. Barooah hints that there are many more such proposals in TPP.
While Ganguli is a “supporter of strong and enforceable IPR laws as they are essential for the socio-economic development of any country and also to build and support an innovation ecosystem”, he believes that there is no need for more such jurisdictions like ACTA or for that matter TPP. Instead, he advocates strengthening and better implementation of the existing framework.
People power
The July 4 vote of the EU Parliament is the latest manifestation of another trend when it comes to IP issues: the battle has long since gone from behind-closed-doors to street protests, sometimes coordinated across the globe in full media glare.
These days, NGOs can match the ‘big industry’ backers of these IPR treaties, in terms of reach and mind space of the consumer, if not funding. In fact, Appaji of Pharmexcil opines that the ratification process of ACTA in the proposed form would not be possible due to the very active role played by international NGOs.
Shah of IPA also points to other allies: the media which played an important role in creating awareness and educating people on what is just and equitable as also the convergence of various forces (like health activists, civil liberty movement and internet users) to a common position. EU citizens organised street demonstrations, e-mails to MEPs and calls to their offices. EU Parliament also received a petition, signed by 2.8 million citizens worldwide, urging it to reject the Agreement.
These efforts managed to turn the tide, reversing the unanimous support ACTA receivedfrom the EU, with the heads of all 27 EU member countries signing it last December. By July some member states obviously had second thoughts and feared a backlash. A ratification needed the consent of all member states, and with only 22 states consenting, ratification was not possible. The overwhelming vote against the ratification – 39 in favour, 478 against, with 165 abstentions – is a testimony to the increased awareness levels on this issue.
Of course, there is always the chance that ACTA could be resurrected in the EU. Shah points out that the EU Parliament has referred the ACTA to the European Court of Justice (ECJ) seeking opinion on its consistence with the EU Law. A favourable opinion could provide an avenue to modify the objectionable provisions and seek endorsement of the Parliament, he reasons.
But this tactic might just back fire, as the Kenyan Government found out the hard way when it tried to push through an anti-counterfeit act. Appaji refers to the recent judgement of the Kenyan Supreme Court, directing the Government of Kenya to re-look the anti-counterfeit act, and he feels that “the attempt of vested interests in blocking the use of generics is losing ground.”
Coupled with the Indian Government’s initiative of taking the ‘Brand India Pharma’ campaign global, Appaji feels that Indian pharma will strengthen its position in international markets. Pharmexcil is also organising the first ever India Show at this year’s CPhI World Wide in Madrid. Projected as the first such show exclusively for the Indian pharma sector, this is another indication of the Government’s determined effort to establish Indian pharma as a dependable source for quality generics at affordable prices.
Signing off, Shah opines that this is an ongoing battle (i.e. protecting India’s ability to manufacture and supply off-patent medicines at the affordable prices) and it would have moments of success as well as failures. One hopes that as IP law continues to evolve and mature, consumer/ patient interest will reign supreme.
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