Drug Regulation Others

Part I: Seizure of Medicines In Transit #Broad Issues At Play

I write to bring to your notice a World Health Organization (WHO) “Discussion Document” (non-binding) that proposed “possible justifications for an intervention on the ground of public health” with respect to seizures of medicines in-transit. The same is a relevant concern because  transit countries have, in the past, seized drugs meant for other countries solely on account of the drugs violating the transit country’s patent regime. 

After a series of seizures of in-transit drugs of Indian origin during the period of 2008-09, India agitated the World Trade Organization (WTO), in 2010, to direct EU countries to refrain from detaining drugs in-transit. Though the EU, in 2011, agreed to refrain from such seizures, I have taken this opportunity to delve deeper into the issue, which reveals questions that lie at the interface of both international law and intellectual property law. Prashant and Swaraj have written on this here and here.

Over the course of a two-part post, we will be delving into the following:

I. The Discussion Document and Broad Issues at Play (Part I)
II. The European Union (EU) Law on Seizure of Drugs In-Transit (Part II).
III. TRIPS, Doha Declaration and the GATT. (Part II)

The Discussion Document

Please note that the Discussion Document was unavailable on the WHO website or any other publicly available source. Therefore, I have relied upon The Times of India and Intellectual Property Watch (Cross-post from Third World Network) reports (here and here).

The Discussion Document suggested the following grounds for confiscation of in-transit drugs:

I. Reasonable grounds for suspecting the medicines to be falsified or substandard and/or
II. Reasonable grounds for suspecting the medicine was going to enter the transit country’s market and/or
III.  Reasonable grounds for suspecting the medicine was a threat to public health and/or
IV. Reasonable grounds for suspecting the medicine was a threat to the environment.

The working definitions for the words inter aliasubstandard medical products” and “falsified medical products” can be found in this WHO document.

The Discussion Document  was meant for the 6th meeting of the Member State Mechanism (MSM), which took place in Geneva between 28th November and 1st December. The MSM was established, in 2012, through Resolution 65.19 of the World Health Assembly to address the problem of Substandard, Spurious, Falsely labelled, Falsified and Counterfeit medical products.

All released documents relevant to the MSM’s 6th meeting can be found here.

All released WHO documents related to Substandard and Falsified Medical Products can be found here.

Broad Issues at Play

There are three key areas that we need to discuss:

i. Public Health
ii. Sovereignty
iii. Jurisdiction

Brazil and Medecins Sans Frontieres have gone as far as to suggest that the European Union was intentionally favouring the companies of the west, at the cost of restricting access of affordable medicines to developing countries. Amidst all the legal arguments, it is easy to overlook the fact that there is a major public health issue at play here.

Countries have varying standards for granting patents. For instance, some countries might value access to medication over rewarding innovation. A patent, therefore, is a territorial right. Transit countries, by enforcing their regime over goods that were meant for another country are indirectly infringing upon the destination country’s sovereignty.

Finally, there is the concern of jurisdiction. The detainment of in-transit drugs raises queries regarding the extent of a transit country law’s applicability to goods in-transit. For instance, would the transit country’s labour laws apply too? As explained above, a patent regime is territorial in nature and therefore, extending a territorial law to goods with no link to the corresponding territory is logically inconsistent.

Coming up:

In Part II, we will deal with the EU law, in addition to the TRIPS, Doha Declaration and the GATT.

Prateek Surisetti

Alias: Suri Net Worth: 0$. NALSAR Batch of 2019. Characteristic Features: 1. Thinks he's funny. 2. Can't shut-up about having topped in Class II. 3. Takes deep personal offence when his cricketing talent is questioned. 4. Will definitely reference his status as World#1 @ Reflex Ball (A sport he invented), within 10 minutes of conversing with him. Notable Endeavours: 1. Founder Access Fitness (Movement at NALSAR that promotes utilization of public spaces for furtherance of sport and fitness) 2. Author "Good Morning Miss Hobby" 3. Travel Photographer (Antarctica, India) Details @ www.facebook.com/prateekss Contact: [email protected]

One comment.

  1. Rajesh G

    Let us make an appeal to all pharma / non-pharma friends to ban Europe as a transit point while travelling to North America / Latin America for all Business meetings, conferences or as personal visits. Why do these countries gain taxes from air travel?? if they are reluctant to take the social responsibility on access to life extending medicines


Leave a Reply

Your email address will not be published. Required fields are marked *