FTA’s and TRIPS Flexibilities: An Oxymoronic Safeguard?

The concept of TRIPS flexibilities is one that has been regurgitated time and again in the literature on IP and development. The most profound pronunciation of this concept can be traced back to the late Murasoli Maran, who, during his time as India’s Commerce Minister quipped:

“We are all aware that the text of the TRIPS is a masterpiece of ambiguity, couched in the language of diplomatic compromise, resulting in a verbal tight-rope walk, with a prose remarkably elastic and capable of being stretched all the way to Geneva.”

In the recent past, the issue of TRIPS flexibilities has gained prominence owing to the rapid proliferation of Free Trade Agreements (FTA’s) that impose TRIPS plus obligations on economically weaker contracting states and help emasculate the rather vibrant policy space around TRIPS standards. Paradoxically enough, some FTA’s now carry a clause explicitly mentioning that the FTA does not in any way impact TRIPS flexibilities that are otherwise available to contracting parties to deploy whilst implementing TRIPS standards (referred to losely as TRIPS flexibility “safeguard clause”).

Illustratively, in the light of accusations that the IP chapter of the proposed India EU FTA will have a detrimental impact on access to affordable medicines in India and other developing countries relying on cheap generics from India, the EU Commission recently emphasised that it has proposed a “clause that will guarantee that no provision of the FTA will prevent India from using the flexibilities contained in the TRIPS Agreement”

Dr Henning Grose Ruse Kahn, a leading international IP and trade scholar from the Max Planck Institute who’s already featured on this blog several times in the past has a wonderful paper that assesses the import of this “safeguard clause”.

I extract Hennings’ abstract below:

“Fifteen years after the WTO TRIPS Agreement entered into force, international IP law and policy have moved on. Since the mid-nineties, countries interested in higher IP standards have successfully shifted IP negotiations away from WIPO and WTO towards Free Trade Agreements (FTAs).

The trend towards TRIPS-plus obligations in FTAs has led to changes in the perception of TRIPS: initially viewed by developing countries as serving primarily the interests of the IP exporting industries in the developed world, TRIPS is now often acknowledged for the flexibilities it offers.

Various institutions, policy makers, and NGOs have highlighted the importance of TRIPS flexibilities – especially in the public health and human rights context – and have called for safeguarding the right of WTO Members to exercise them against TRIPS-plus obligations in FTAs. This includes the main demandeurs of TRIPS-plus obligations FTAs which increasingly commit themselves to safeguarding TRIPS flexibilities.

Given all these statements and assurances, the question arises how FTAs have incorporated these promised policy changes and whether the relevant FTA provisions really translate political assurances into binding treaty language. This Article aims to examine this question from a public international law perspective. It analyses the relationship between TRIPS flexibility provisions and TRIPS-plus FTAs. By looking at norms in general international law, the TRIPS Agreement, and in TRIPS-plus FTAs which determine this relationship, the main research question is whether and when TRIPS flexibilities can prevail over TRIPS-plus obligations in FTAs.”

Henning’s key thesis is that the emerging set of ‘safeguard’ clauses in TRIPS-plus FTAs offers an interesting way out for developing countries that are at the receiving end of harsh FTA’s. They often can be used to achieve policy space similar or equivalent to that offered by TRIPS flexibilities. However, this requires the willingness and ability of interested FTA parties to do so. Only time will tell whether these clauses possess nothing more than mere parchment value or whether they will ultimately help preserve TRIPS flexibilities….

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2 thoughts on “FTA’s and TRIPS Flexibilities: An Oxymoronic Safeguard?”

  1. Dear Shamnad,

    Where is the statistical data on how developing countries actually have fared under the plethora of existing bilateral/regional FTAs with regard to access to medicines?

    Do you have ANY data from the dozens and dozens of bilateral and regional FTAs in the pharmaceutical area?

    From what I have seen based on experience of Mexico, Jordan, Morocco, there is at least some credible data on the other side, as follows:

    Mexico: Increased rates of vaccine access for infants and young children & reduced infant mortality/morbidity;

    Jordan: Increased access to innovative meds and greatly increased clinical research opportunities for physicians, medical centers, and for patients seeking cutting-edge therapies (In fact on the FTA anniversary in 2004 when I was in Amman the biggest complaint by local companies was collapse of pricing due to increased international competition – not increased prices due to patents!!);

    Mexico, Jordan and Morocco (ALL THREE US FTA PARTNERS): multi-year on year double-digit economic growth in the pharma sector (local and MNC) in all three markets.

    This data is all largely available in the public domain – so why can’t the NGOs who oppose these FTAs similarly provide statistical data that shows a “before” and “after” snapshot of social and economic impact, including access to essential medicines?

    Instead it always seems to be a question of a “how long have you been beating your wife?” type of debate.

    If you like I can set up a place to post to the Finston Consulting website all of the public reports that I have referenced above – some in foreign languages, unfortunately – , also I have made some presentations on these issues based on these reports available online here including a presentation at the National Science Foundation (NSF)an MENA Women in Science and Technology conference held in Abu Dhabi in April 2010.

    So I would LOVE to see a head-to-head comparison of data to show the real economic and social impact of FTAs on the pharma sector, including: trade, investment, increase in innovative meds available locally, access to meds more generally, vaccination rates, infant mortality, etc.!!

    Then we can have an engaged, intelligent debate about what India should or should not accept in any FTA negotiation.

    Otherwise is it all ideology.

    Thanks and BR,


  2. Henning Grosse Ruse - Khan

    Although the research underlying Shamnad’s post concerns a rather purely technical legal topic (on norm-relationships in international law), I agree with Susan that empirical analysis on the economic and social impact of FTAs and their IP chapters is in need and currently (to my knowledge) lacking. (In fact, just a few days ago I discussed with a colleague who – because of this lack – plans to do research in this area.)
    Without having assessed Susan’s data, I however fear that most of the empirical research is likely to be rather inconclusive as to pinning down the exact effects a certain ‘TRIPS-plus’ FTA provision may have. I fear that it will lead to the same inconclusive debates about the impact of TRIPS on the socio-economic developments (e.g. on increases in FDI, technology transfer). Often, the precise as it gets is that IP is one of many contributing factors and that others, especially macroeconomic factors (or their combination and inter-relation), play a much more significant role. That leads to the one conclusion which so far seems to be universially valid and so uncontested that the World Bank, WIPO, UNCTAD the WTO and others are adopting it: The finetuning of IP protection should be tailored to the domestic circumstances of the country at stake!
    And it is exactly this ability to finetune which may be eroded by more and more international commitments for a certain level of IP protection (pacta sunt servanda). Of course, such commitments also ensure certainty and legal security for (foreign) market actors and hence are certainly not to be avoided as such – but they should be carefully balanced against the degree to which a country looses its ability to tailor IP protection to suit its domestic needs.
    In the post and in my related paper, the point never was to argue about which form of TRIPS-plus FTA obligation is good or bad for a FTA trading partner. It was rather about the tendency (of the TRIPS-plus demandeurs in FTA negotiations) to include ‘TRIPS-flexibility safeguard clauses’ and whether these clauses – from a technical legal analysis – actually live up to their promises.


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