On 25 October 2011, India delivered the following intervention at the WTO TRIPS Council raising concerns on ACTA and the TPPA during discussions of “Trends in the Enforcement of Intellectual Property Rights”. On ACTA, India voiced concerns on the scope of ACTA’s civil enforcement measures, border measures potential role in the seizure of generic medicines, third party liability, damages and also raised systemic issues such as how WTO MFN obligations would affect WTO members who are not ACTA parties,
The MFN provisions of the TRIPS agreement mean that any TRIPS+ protection secured by any trading partner via an RTA or a plurilateral agreement is ipso facto applicable to all other WTO members. Thus this agreement will have a direct bearing even on the members not involved in ACTA, but who will subsequently enter into RTAs with ACTA signatories.
On the TPPA, India voiced objections on measures that require “patentability of new uses and minor variations of older known drugs”, provisions that would prohibit pre-grant patent opposition and measures that would require patent linkage.
Intervention on “Trends in the Enforcement of Intellectual Property Rights”
Members will recall that during the past several TRIPS Council meetings, India along with other countries have consistently highlighted the systemic implications of TRIPS+ initiatives launched by a few country members. The ensuing discussions demonstrated the concerns echoed by a vast majority of WTO members about how ACTA through its TRIPS+ provisions can disturb the fine balance of rights and obligations provided in the TRIPS agreement and negate the decisions like the Doha Declaration on Public Health. In today’s meeting under the Agenda item ‘Trends in the enforcement of Intellectual Property Rights’ the ACTA signatories would like to brief the Council about the recently signed plurilateral ACTA agreement between 8 countries.
After years of negotiating in comparative secrecy we appreciate that the ACTA signatories have finally become transparent and have taken the initiative of briefing the Council about ACTA , that too under the Agenda item “Enforcement of Intellectual Property Rights (Part III of the TRIPS Agreement)”. We would also like to thank them for their constructive engagement in changing the title of their agenda and making it clear that it will be a one time affair and not a permanent agenda item.
Let me highlight some important specific and systemic concerns that we have regarding ACTA.
1. The scope of ACTA is broad and we feel that it would target generic medicines, which have served as a lifeline by providing access to medicines at an affordable cost in developing countries. The signatories to ACTA say that it is intended to help them effectively combat the proliferation of counterfeiting and piracy and to protect consumers from potentially dangerous products like counterfeit medicines. However, ACTA does not limit itself to counterfeits, a category of products defined narrowly in the TRIPS agreement as involving the deliberate or fraudulent use of trademark in order to deceive consumers. Instead ACTA targets all forms of intellectual property infringement under the guise of targeting counterfeits. ACTA civil enforcement measures apply broadly in connection with IP infringement, although the parties have the option of excluding patents and undisclosed information from the scope of civil enforcement. Goods that are suspected of infringing IP, broadly defined, may be seized by customs officials under ACTA. This is worrisome especially from a public health point of view as ACTA measures would target generic medicines.
2. ACTA border measures which are TRIPS+ on several grounds, constitute a grave threat to trade in generics. The customs detention of legitimate Indian generics through the European Union on account of the EU border measures demonstrates the adverse impact that such border measures can have on public health on a global scale including life saving medicines to treat HIV/AIDS , heart diseases etc. Under ACTA, such seizures would continue. The Agreement provides for the imposition of border measures following requests by right holders or as a result of ex-officio action by customs officials. ACTA also provides for border measures for the goods in transit through a signatory – even if they do not infringe any IP in the place of production or where they will be consumed. Our apprehension is that ACTA will pose grave risks for international trade in generics and thereby adversely affect public health initiatives in developing countries.
3. Under ACTA, third parties supplying inputs or services in support of the manufacture or commercialization of allegedly IP infringing products could be subject to civil and criminal sanctions. The imposition of so called third party liability will dissuade suppliers from selling inputs and services to even genuine generic manufacturers. In addition, ACTA also requires that the officials be authorized to grant injunctions including for third parties contributing to alleged infringement of IP, in order to prevent the infringing goods from entering the channels of commerce. ACTA language on aiding and abetting could affect providers of inputs including those that unknowingly supply labels, materials or services to IP infringers. This would have an adverse impact on the availability of affordable medicines globally.
4. ACTA rules provides that an infringer, who knowingly or unknowingly engaged in infringement, may be ordered to pay damages in order to compensate for injury to the rights holder and introduces TRIPS+ rules for calculating damages. The calculation method of using the lost profits on account of alleged infringement will act as a deterrent for involvement with a generic manufacturer and these will deter generic producers in entering new markets.
5. As far as systemic concerns go, ACTA bypasses the multilateral processes of WTO or WIPO and goes way beyond the enforcement levels laid down in the TRIPS agreement. The MFN provisions of the TRIPS agreement mean that any TRIPS+ protection secured by any trading partner via an RTA or a plurilateral agreement is ipso facto applicable to all other WTO members. Thus this agreement will have a direct bearing even on the members not involved in ACTA, but who will subsequently enter into RTAs with ACTA signatories. ACTA has thus inalterably changed the balance of rights and obligations of the parties to the TRIPS agreement, without their having had any say in the negotiation of ACTA.
6. It also causes us concern when enforcement is seen as divorced from other obligations in the TRIPS agreement. To recall, Articles 7 and 8 of the TRIPS agreement refer to transfer of technology, socio economic development, promotion of innovation and access to knowledge.
Mr Chair, I would also like to draw the attention of the Council members to the Trans Pacific Partnership Agreement currently under negotiation. We have seen unconfirmed reports appearing in the media, which we cannot rely on or discount entirely, on the proposals made by a developed country regarding the IPR chapters of Trans Pacific Partnership (TPP) Agreements. This agreement could also end up seriously hampering public health efforts in developing countries. As per some reports, the stance of some parties at the TPP, if agreed upon, will result in creating monopolies for the big pharma companies and driving out generic manufacturers from the global market. While on this point, let me highlight some of the proposed measures that are of serious concern to India and a majority of WTO members.
1. As per reports there are proposals that can undermine the provisions and flexibilities in the TRIPS agreement by requiring patentability of new uses and minor variations of older known drugs. This will result in indefinite lengthening of the patent life and undermine the generics industry.
2. There is also a proposal to lengthen the patent period by taking into account the time required for getting marketing approval. This will bring in subjectivity in the patent life and delay the entry of generic drugs.
3. There are also provisions against pre-grant opposition and compulsion to provide for patent linkage. Thus even a spurious drug can act as a barrier by bringing in patent linkage in the agreement.
4. There is also a proposal to dictate the pricing of drugs in the country by big pharma companies. Thus even the prices of essential drugs which are kept low by the countries in public interest would be dictated by the big pharmas.
Mr Chair, let me conclude by saying that we are deeply concerned by ACTA and agreements under negotiations like TPP, which aim at enforcing TRIPS+ measures directly or indirectly on the WTO membership. While India is committed to dealing with IPR enforcement issues in line with its TRIPS obligations, the introduction of intrusive IPR enforcement rules has indeed setup very high non tariff barriers in the multilateral trading system and we cannot remain oblivious to such developments. We also need to avoid exaggerating the issue of counterfeiting and piracy since there is no available empirical data. We need to have much more work done in this area. Members need to work collectively to maintain the sanctity of the international trading environment by respecting the multilaterally negotiated agreements like TRIPS.