Info Service on WTO and Trade Issues (June09/12)
demands in EU-India FTA could adversely affect access to drugs
Geneva, 17 Jun (Sangeeta Shashikant*) -- The European Union's demands on India to take on higher intellectual property (IP) standards, if adopted, could spell disaster for the supply of low-cost generic medicines, undermine India's development and set a significant precedent for the future of IPR protection globally, cautioned Dr Carlos M. Correa, an expert on IP and the WTO TRIPS Agreement.
Correa's warning is in a recent report by him titled "Negotiation
of a Free Trade Agreement European Union-India: Will
report by Dr Correa analyses the sections on IPR in the draft EU-India
FTA that was available before the sixth round of negotiations held in
Noting that India is home to one of the largest populations of poor people in the world, Dr Correa warns that the explicit demands by the EU for India to adopt higher standards of IPR protection will "only aggravate the exclusion of the poor from access to essential products, such as medicines and input for agricultural production, the very basis for the survival of the largest part of [the] Indian population".
The higher IP standards sought by the EU are also likely to spell disaster for the supply of low-cost generic medicines for the world, as the EU proposes provisions that extend patent monopoly and delay generic competition.
"The intention to exceed the TRIPS standards is explicit," states the report. This is so despite the European Parliament's repeated calls on the European Commission not to seek TRIPS-plus standards of protection in developing countries, as they may affect access to medicines.
The report notes that as a result of the "Most Favoured Nation" clause, any TRIPS-plus standard agreed upon with the EU would also be extended automatically and unconditionally to other WTO members without any trade concession from them.
further notes that the texts indicate that
While in some cases, India appears to have rejected the EU proposals, in other cases, the strategy has apparently been to accept certain obligations but only to the extent admissible under "existing" or "applicable" laws or where the proposed measures are deemed "appropriate" by the relevant authorities, or the provisions are redrafted by India as facultative ("the Parties may..."), or converted into a best-effort obligation ("the Parties shall endeavour...").
"noticeable gap" is that the draft FTA does not contain provisions
aimed at curbing the misappropriation ("bio-piracy") of traditional
knowledge and genetic resources, says the report, which speculates that
It advises that "the FTA might be an opportunity to demand from [the] EU full compliance with the Convention on Biological Diversity and, in particular, the incorporation of an obligation on patent applicants to disclose the origin of biological materials claimed in a patent application".
In relation to patents, the report highlights two TRIPS-plus provisions, which if adopted, may significantly limit access to drugs.
first proposal, modeled on the concept of "supplementary protection
certificate" in the EU, compels
On the proposals' implications, the report notes that the first proposal would "extend the monopoly conferred by a patent and delay the entry of generic competition, which reduces prices and increases the affordability of drugs", while as a result of the second proposal, "Indian consumers may be deprived during the test data exclusivity period of access to low-price drugs, even in the absence of a patent on the respective product".
The report finds a positive feature in that the draft FTA at least recognizes the "importance of the Doha Declaration on the TRIPS Agreement and Public Health adopted on 14 November 2001 by the Ministerial Conference of the WTO", which "should be applied for interpretative purposes in the case that a dispute arises between the Parties".
Another positive feature in the draft FTA is the statement that "[N]othing in this Agreement shall be construed as to impair the capacity of the Parties to promote access to medicines". The report however notes that the "precise implications" of this formulation are yet to be determined.
The report also notes that the draft FTA stipulates that Parties "shall contribute to the implementation and respect" of the WTO Decision of August 30, 2003 (which allows for the exportation of pharmaceutical products under compulsory licenses to countries without manufacturing capacity in pharmaceuticals), and agree to take the necessary steps to accept the Protocol amending the TRIPS Agreement, done in Geneva on 6 December 2005.
EU has also proposed that
report however cautions
The PLT limits the grounds for revocation or invalidation of a patent in a way that may exclude the possibility of taking measures in case of lack of disclosure "except where the non-compliance with the formal requirement occurred as a result of fraudulent intention," states the report.
In the area of breeders' rights, the draft FTA "obligates the Parties 'to co-operate to promote and reinforce the protection of plant varieties' based on the Convention on the Protection of Plant Varieties (UPOV) 1991", says the report, adding that India presently deliberately protects plant varieties according to UPOV 1978, as "1991 is perceived as altering the balance attained in the 1978 Act between breeders' and farmers' rights".
However, it notes that the specific reference in the draft FTA to the possibility of introducing an exception for the use in their own exploitation of seeds saved by farmers (a right explicitly recognized under the Indian law), "would be sufficient to change India's resistance to expand the protection accorded to plant varieties in line with UPOV 1991".
In the area of copyright, the report notes the EU requests of Indian accession to a number of international conventions, including the Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations, the WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty.
This demand, according to Dr Correa, "shows the complementarity of plurilateral and bilateral efforts by the EU to increase the levels of protection of IPRs in foreign countries".
to the report,
In line with the trend promoted by the developed countries, the EU has demanded the extension of the copyright protection term.
an "apparently agreed text", both parties agreed to commit
to 60 years to recognize author's rights after death, a right that already
The EU would however like to extend the protection term from a different date, such as the first publication or communication of a performance or of a phonogram.
to the report, there seems to be no agreement regarding a complex provision
proposed by the EU on "Broadcasting and Communication to the Public",
which would significantly reinforce related rights. The EU has also
are also demands for
"Measures designed to prevent third parties from unauthorized access to and use of digital works may, in effect, permit right-holders to control, monitor and meter every possible use of a work. If strengthened by the legal prohibition to defeat them, such measures may prevent fair use and other legitimate acts".
operative set of exceptions to the exclusive rights granted under copyright
is essential in a country like
The report notes that the EU is also attempting to embark India on the protection of "non original databases", despite a critical evaluation by the European Commission that casts serious doubts over the necessity of the sui generis protection established by Directive 96/9/EC of the European Parliament and of the Council on 11 March 1996 on the legal protection of databases.
According to the report, the Indian government has apparently rejected this demand.
the area of trademarks, the EU draft requires accession (by
Correa notes that
"Accession to the latter may limit the intervention of national office in the registration of marks of foreign origin, and is resisted in many countries by local trademark agents," says Dr Correa.
The EU draft also contains detailed provisions on the protection of geographical indications (GIs), although according to Dr Correa, no agreement on it exists as yet.
The EU proposals include (in addition to the recognition of specific GIs for agricultural products and foodstuffs, wines, aromatized wines and spirits) a mechanism for the addition of new GIs as well as provisions on the use of GIs in Internet and organizational matters.
The IP expert notes that "incorporating this kind of TRIPS plus provisions in this FTA will represent a significant achievement for European countries... who have consistently championed an expansion of the international protection of GIs".
Dr Correa recommends that "given the scarcity of research-based
inputs on the impact of GIs protection, it has been recommended a more
prudent approach on the part of
As the EU has in the last five years become very active in the field of IP enforcement, the longest detailed section is on the adoption of different types of enforcement measures.
The EU's initiatives on promoting IP enforcement include Enforcement Directive 2004/48/EC to enhance enforcement among member states, the "Strategy for the Enforcement of Intellectual Property Rights (IPRs) in Third Countries", which aims to enhance IPR enforcement outside the EU and the negotiation of a new "Anti-Counterfeiting Trade Agreement (ACTA)."
on enforcement include those that: specify the type of evidence
Also included among the proposals are those that: provide for pecuniary compensation for cases where infringement was "non-intentional and without negligence", stipulates about the determination of damages, imposes legal costs and other expenses on the unsuccessful party; require the publication of judicial decisions; provide for a presumption of ownership in the case of enforcement of copyright and related rights; regulate the liability of intermediary service providers; obligate the Parties to adopt expansive border measures; and to encourage the development of codes of conduct aimed at contributing towards the enforcement of intellectual property rights and to enter into forensic cooperation.
to Dr Correa, for the most part, except on presumption of ownership,
He cautions that the "proposed expansion of border measures much beyond what is required under the TRIPS Agreement would make such measures applicable not only to the importation but also to the exportation of goods and to goods in transit".
He notes that the seizures of generic medicines in transit by the European customs authorities illustrate the possible implications on legitimate trade of the broad application of border measures.
"This case not only shows the problems posed by the application of IPRs to goods merely in transit (which may constitute a violation of Article V of the GATT) but also the inadequateness of applying, as proposed by the EU, border measures to patent infringements", as "determination of such an infringement generally requires complex technical testing and raises difficult legal issues, such as the interpretation of the scope of patent claims (namely, in order to establish whether a non-literal violation exists)," says the report.
"Custom authorities lack the capacity to properly handle these issues", the report adds.
Correa also says that there is nothing in the EU-India FTA that "would
enhance technology flows from Europe to
The draft EU-India FTA limits itself to the "Parties' exchange of views and information on their domestic and international policies affecting transfer of technology' and to the creation of an enabling environment for technology transfer in the host countries, including issues such as the relevant legal framework and development of human capital'".
general declaration, Dr Correa adds, seems "to put on
(* With inputs from Asmeret Ashgedom.) +