Analysis: WTO Amendment On Access To Medicines Faces EU Conundrum 14/04/2016 by Peter Ungphakorn for Intellectual Property Watch 5 Comments Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)After waiting for over a decade, the World Trade Organization is finally close to achieving the first ever amendment to its rule-book, with only a handful of members still needing to formally accept new intellectual property provisions dealing with one aspect of access to medicines. Two thirds of the membership (108 of the WTO’s present 162 members) have to ratify or “accept” the amendment (on exporting medicines made under compulsory licence) before it can take effect. The number of accepting members is finally approaching 108. This has exposed a discrepancy in the way the European Union’s membership is counted. And that in turn raises questions over when the 108 is actually reached. Worse, the counting method the EU uses could even prevent some amendments ever taking effect. The Strange Case of the Missing EU Member Normally, the EU is counted as 29 WTO members: its 28 member states plus the EU itself. This explains why the WTO’s membership is currently 162. Counting the EU as 29 would mean that 97 members have accepted the amendment, and only 11 more are needed to reach 108. The WTO confirmed this. “We are 11 short of the two thirds we need,” WTO spokesman Keith Rockwell told IP-Watch. “We expect Qatar and Tajikistan to ratify [in April] which would then leave us nine short.” But the European Commission, which speaks on behalf of the whole EU, has a different count: 28. “To our best knowledge, the number of votes the EU has according to the WTO agreement corresponds to the number of EU Member States, which is 28,” said Daniel Rosario, the Commission’s spokesperson for trade (note “to our best knowledge” and “votes”). “Therefore … the TRIPS amendment would at this point be 12 WTO members short of entry into force.” Rosario said. In this particular case, the discrepancy makes no difference to the real world. The content of the amendment is already in effect through a legal instrument known as a “waiver”, which remains in place until the amendment takes effect. So politically, the WTO may be able to go ahead and celebrate its first ever rule-change without having to worry about the legal niceties. But the WTO is above all a legal organisation, where getting the rules right in detail does matter tremendously, as can be seen from any official WTO document or dispute ruling. The EU and WTO have had nine years to try to sort out this question — the EU accepted the amendment in 2007. It remains unresolved. Even if this particular amendment has little impact on the real world, failure to sort out the legal issues could hold up future amendments that will count. One is already in process, on “trade facilitation” (streamlining border procedures) — more below. And for a handful of critically important provisions, all WTO members have to accept an amendment, not just two thirds (Article 10.2 of the WTO Agreement). In present circumstances, that means 162 acceptances, a figure that can never be reached if the EU is only counted as 28. Something has to give. The Issue: Compulsory Licensing for Export The 1994 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) contains a number of flexibilities allowing governments to bypass certain patent rights, including for pharmaceuticals. One is compulsory licensing (or some other means) where the government can decree that generic versions can be made without the permission of the patent owner, provided some conditions are met, such as an attempt at voluntary licensing. But the agreement also says that for compulsory licensing (or similar action), “any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use” (Article 31(f)). This would normally prevent the generic from being exported to a poorer country. (The original drafters said later that at the time they had underestimated the implications.) In 2003, WTO members agreed to change the rule so that medicines made under compulsory licence could be exported to countries that are unable to make the medicines themselves. The legal means was a “waiver” — Article 31(f) is waived provided certain conditions are met such as special packaging and distinctive marks for the generics, and notification to the WTO. Specifically, countries following the provisions of the waiver will not be challenged under the WTO’s legal dispute settlement system. Two years later, WTO members agreed to turn the waiver into an amendment of the TRIPS Agreement. The waiver remains in place until the amendment takes effect, without any need to renew it. The main reason for doing this is to be legally tidy. A waiver deviates from the rules; an amendment is part of the rules. The one practical benefit is visibility: the waiver cannot be seen among the WTO agreements, whereas an amendment would be included. Other than that, switching from the waiver to the amendment makes no difference at all from the point of view of public health: Access to medicines (the right to export a product under compulsory licence) is identical The requirements for distinctive packaging and marks are identical The notification requirements are identical Protection against legal challenge is also unchanged (The two are compared unofficially here [pdf]) More than 10 years after the amendment was agreed, it is only now approaching enough acceptances for it to come into force. The slow pace of acceptances should not be seen as a lack of interest in access to medicines because the amendment makes no practical difference. The real intergovernmental work on access to medicines is taking place elsewhere including collaboration between the World Health Organization, World Intellectual Property Organization and WTO. Rather, it is a lack of commitment to the system and the institution — a failure to follow up on a decision taken many years ago and to ensure multilateral rules are tidied up — which may sound abstract but is at the heart of the WTO’s functions. Counting Members, Votes and Instruments The failure to sort out how the EU is counted reflects a similar lack of commitment to the institution. The WTO and EU seem to be basing their versions on different WTO rules. The WTO’s approach is straightforward. The EU is 29 members out of 162, and that also applies to the number accepting an amendment. The EU’s method is different, counting itself as 28 WTO members instead of 29. EU spokesman Rosario only cited the Trade Facilitation Agreement which was agreed in 2014 — nine years after the TRIPS amendment — and is set out as an amendment to the package of WTO agreements. Here, a footnote says the EU should be counted as the same number as its member states (28). Counting the EU as 28 for the TRIPS amendment “is in line with the one recently agreed in another multilateral instrument, the Trade Facilitation Agreement,” Rosario said. In WTO agreements, the only case where the EU would be counted this way (28) is for voting (Article 9.1 of the WTO Marrakesh Agreement). Presumably this was designed to avoid giving the EU a numerical advantage over countries voting on the opposite side. (Voting has only ever been used once — and some say even that was a mistake — because members prefer decisions by “consensus”, defined as: “if no Member, present at the meeting when the decision is taken, formally objects to the proposed decision” — footnote to the same Article 9.1.) But the arithmetic of accepting an amendment is different. When the EU is counted this way (28 instead of 29), it is imposing on the WTO membership the need for one additional non-EU member to accept in order to reach two thirds. The rules themselves (Article 10 of the Marrakesh Agreement) do not refer to voting for this purpose, only “acceptance by two thirds of the Members”. (Voting only comes into play explicitly for decisions about amendments.) If the EU is citing some obscure legal principle that accepting or ratifying an amendment is the same as voting, it has not said so openly. There may be another explanation. When a country accepts a WTO amendment it also has to “deposit an instrument of acceptance” with the WTO. If the EU were to be counted as 29 WTO members, its instrument of acceptance would have to be on behalf of all 29, including the EU itself. Internal legal problems may be preventing the EU from doing so, perhaps because that would imply the EU itself has jurisdiction over its member states’ intellectual property regimes, a contentious issue. But if that is the case, again, why not come clean? All we know is what the instrument says: it is attached to the EU in the WTO’s list of acceptances, the only instrument that had to be made available on that list (note that Croatia is listed separately because it accepted before joining the EU). Citing the “Treaty establishing the European Community”, the instrument’s only reference to the member states is that “the Protocol [amending the TRIPS Agreement] will be binding on the Member States of the European Union.” This sounds more like confirmation of a separate issue: that the amendment will apply to the EU member states, rather than an indication of how many have accepted it — according to the rules, an amendment normally only applies to those countries that have accepted it, not to the rest of the WTO’s membership. Possible Solutions, and an Elephant And yet, if the EU and WTO wanted to resolve this, they could, even without a treaty change. These are some possibilities, bearing in mind that if the EU counts only as the number of its member states then it is forcing one additional non-EU member to accept the amendment in order to reach the needed two thirds: An interpretation by the WTO General Council to clarify how the EU should be counted for accepting amendments. This would be the clearest solution. The EU unilaterally declaring that it will accept whatever count the WTO uses (29 in this case), or that it will always be the number of member states plus the EU itself The EU routinely having a footnote clarifying its number as happened with trade facilitation Making sure that at the end two members accept simultaneously, so that the two thirds figure is always reached no matter which count is used. This would be the messiest solution. Finally, the elephant in the room. If the EU really has difficulty accepting a “member states plus one” count for the purposes of amendments, it might go so far as to say that in such cases it considers the WTO’s membership also to be all members apart from the EU itself, ie 161 instead of the present 162. This would give the WTO a variable membership count, which many would find difficult to swallow. Besides, there are no provisions in the WTO agreements for taking this route. P.S. Countries That Have Not Yet Accepted The following non-EU countries have not yet accepted the amendment. After the two thirds have been reached, the amendment will only apply to those that have accepted. It will not apply to any remaining on this list: Angola Antigua and Barbuda Armenia Barbados Belize Benin Bolivia Burkina Faso Burundi Cabo Verde Cameroon Chad Congo Côte d’Ivoire Cuba Democratic Republic of the Congo Djibouti Dominica Ecuador Fiji Gabon The Gambia Georgia Ghana Guatemala Guinea Guinea-Bissau Guyana Haiti Jamaica Kazakhstan Kuwait Kyrgyz Republic Liechtenstein Madagascar Malawi Maldives Malta Mauritania Mozambique Namibia Niger Nigeria Oman Papua New Guinea Paraguay Peru Russian Federation Saint Lucia Saint Vincent & the Grenadines Samoa Seychelles Sierra Leone Solomon Islands Suriname Swaziland Tajikistan Tonga Tunisia United Arab Emirates Vanuatu Venezuela Viet Nam Yemen Zimbabwe Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Peter Ungphakorn may be reached at firstname.lastname@example.org."Analysis: WTO Amendment On Access To Medicines Faces EU Conundrum" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.