India delivered the following intervention at MSF’s workshop at the World Trade Organization Public Forum today. The title of the MSF workshop was “Controversy at customs – the detention of medicines in transit: what impact on access to medicines?”
Controversy at customs – the detention of medicines in transit: what impact on access to medicines?
Wednesday 30 September 2009, 14:15 to 16:15
WTO building, Room A
Since January this year, much has been said, much has been heard but practically nothing concrete has been done about reviewing EC customs Regulation 1383/2003 inspite of its inconsistency with provisions of GATT, the TRIPS Agreement and the spirit of the Doha Declaration on the TRIPS Agreement and Public Health.
Several developing countries including India and Brazil have raised it in the GC, TRIPS Council & other international fora and highlighted that the widespread and repeated seizures, under the EC Regulation 1383, have an adverse systemic impact on (i) the principle of universal access to medicines, (ii) national public health budgets, (iii) legitimate trade of generic medicines, (iv) South-South commerce and also (v) seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world.
Indian efforts with the EC to address the issue:
India has taken up the issue bilaterally with the EC at the level of senior officials and even at the level of Ministers. We have also formally written to the EC several times. We have received a few responses which, other than reiterating commitment to Doha Declaration, gloss over the issue and do not mention any concrete step being taken or planned to be taken by the EC to rectify the situation. The last we heard was two weeks ago when the EC forwarded an ‘Explanatory Note’ dated July 31 which it had sent to Member States on the application of the EC Regulation 1383/2003.
The Note provides us no comfort at all. It merely shifts the blame to MSs for applying their national laws and the responsibility for interpretation to the National Courts. The Note totally disregards the permissiveness of the EC Regulation itself. Prior to 2003, the scope of EC Regulations covered only trademark and copyright infringements. If EC Regulation 1383 additionally covers patents and other IPRs and extends to goods in transit, it alone is to blame for the recent drug seizures since it provides a basis for MSs to apply IPRs extra territorially and to goods in transit. The Note, in a redundant exercise, also repeats the timelines indicated in TRIPS Art 55 (Duration of suspension). Elaborating in great detail on the timelines in the Note seems to be an effort at evading the real issue. It need not be re-emphasized that these timelines were hardly followed by Customs authorities in the various cases of drug seizures in 2008.
Q: Is it true that it is only the national laws of MSs responsible for maximalist enforcement? The Dutch Minister for Foreign Trade, Frank Heemskerk, responding to some parliament Members earlier this month said, “The Dutch customs department acted in accordance with extant EU legislation, and in particular Council Regulation (EC) No. 1383/2003.” The Minister further states that, “The basis of a solution must therefore be sought within European legislation itself.” We can’t think of a clearer articulation of where the problem lies.
The EC even refuses to acknowledge that these were ‘seizures’. They refer to them as ‘temporary detainment’. We do not understand why some consignments were detained upto 4 months inspite of the 10+10 day stipulation of TRIPS. Some consignments never reached the destination countries. The importers were asked to take them back.
We have asked the EC about the fact that although the Regulation is 6 years old, why have the drug seizures taken place fairly recently. We are told about the ambitious ‘Operation MEDI-FAKE.’ Yesterday (29/09/09), at an EC meeting, Patrick Ravillard said “The Regulation’s aim is to stop drugs violating IPRs”. We get very confusing signals. Are the seizures to deal with spurious drugs or IPRs? India is as much against spurious drugs as any other country but here we see a deliberate mixing up of the issue of spurious/sub standard drugs etc with IPRs. Let me also emphasise that the seizure cases involved legitimate generic medicines which are neither fake, nor counterfeit, nor pirated medicines. Actually, all this does not stop there. It seems to be a part of a larger design for maximalist enforcement of IPRs. There seems to be an orchestrated campaign of deliberately confusing quality issues with IPRs in international organisations (WHO), insistence on TRIPS plus elements in FTAs being negotiated and to top it all, negotiating the ACTA amid secrecy and exclusion of a vast majority of countries including developing countries and LDCs.
The EC Regulation 1383 is open to interpretation and implementation in different ways (as in Drugs and Nokia cases), therefore, a Damocles’ sword is always hanging. Our experience has been that the sword falls on generic drugs more than mobile phones.
It is also ironical that while on the one hand, EC countries are providing funds for public health programmes of developing countries, …. at the same time they create barriers to legitimate trade in generics and hamper access to medicines. Actually, EC Regulation 1383 promotes this dichotomy.
The multitude of drug seizures indicate an emerging pattern to disrupt and create barriers to legitimate trade of generic drugs and to challenge the Doha Declaration on Public Health. If the EC is committed to the Doha Decl on PH and supports access to medicines, what explains the repeated drug seizures of medicines including AIDS and serious heart aliments. Is it that with the decline in patenting of ‘block buster drugs’ and ‘new chemical entities’ European pharma companies see a threat from generic industry as more and more drugs go off patent. If this is so, it comes at a huge humanitarian cost.
On the issue of WTO compatibility, in our view, EC Regulation 1383/2003 violates GATT Art V that allows Freedom of Transit by most economical and convenient routes and without unnecessary delays and restrictions. It also violates border measures enshrined under Art 41-61 of TRIPS. In particular, the application also violates the key TRIPS principle of ‘territoriality’ and Art 41 which obliges Members to ‘avoid creation of barriers to legitimate trade’. This is not our view alone. The European Generic Medicines Association (Feb 2009) wrote to the EC saying that such and application to drugs which are IPR compliant in country of origin and destination ‘will effectively create a barrier to the trade in legitimate generic medicines worldwide’ and ‘is contrary to Art 41 of the TRIPS Agreement.
Coming back to Mr. Rallivard’s statement yesterday in Brussels, he outlined several initiatives “not to disturb the legitimate trade of generics, also when they are in transit “ viz. (i) reminding MSs and national authorities to pay attention to the distinction between counterfeit/generic, (ii) giving further instructions/information to customs, (iii) initiating a dialogue with pharmaceutical industries, associating India and Brazil in this exercise of transparency and dialogue. We agree that transparency and dialogue are essential. However, it would be interesting to note that we are yet to hear from the EC about the details of the seized consignments. Our only information is the one provided by the Dutch Govt in response to a request made by HAI (Europe). Mr. Rallivard also mentioned that “In addition, the EC is reviewing the whole Regulation and will keep alert on this dossier.” We also hear several MEPs making the demand to review the Regulation 1383/2003. Mr. Luc Devigne could elaborate on whether the EC has serious plans to review 1383/2003..
Our conclusions:
The issue of seizure of drug consignments is not merely a trade issue. It is a humanitarian issue. It is an issue of immense public interest……of access to affordable and efficacious medicines…and closely related to the Right to health. This concern is clearly brought out in the report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health submitted to the 11th Session of the Human Rights Council in June this year.
The EC needs to ‘walk the talk’ in its stated commitment to facilitate access to medicines in developing countries and the DDPH. We see the EC Regulation 1383/2003 at the root of the problem. To find a lasting solution to the problem it is imperative that the Regulation 1383/2003 is reviewed and brought in line with GATT/TRIPS and the spirit of the Doha Declaration on Public Health.