TWN Info Service on Intellectual Property Issues (Oct14/10)
30 October 2014
Third World Network

EU pushing for a right to intercept medical products in transit

Geneva, 30 October (Chee Yoke Ling) – The European Union is pushing for a right to intercept and seize medical product shipments in transit on the way to final importing destinations, on the grounds of suspected quality, safety and efficacy.

This position is a clear articulation of the EU’s trade agenda to erect non-tariff barriers to check the competition of generic medical products.

This issue first came up during an informal technical meeting of the World Health Organization’s Member State Mechanism on Substandard/Spurious/Falsely-labeled/Falsified/Counterfeit (SSFFC) Medical Products on 27-28 October in Geneva. The meeting was held to finalise a list of actions, activities and behaviours that should be outside the mandate of the Member State Mechanism (MSM), and separated from the list of actions, activities and behaviours that result in SSFFC medical products that pose a public health risk.

This list is currently being discussed by the third formal session of the MSM, which is meeting from 29 to 31October.

The MSM was established by WHO Resolution 65.19, and mandated to prevent and control substandard/spurious/falsely-labeled/falsified/counterfeit medical products from a public health perspective, excluding trade and intellectual property considerations.  

Objective 4 of the MSM is to identify actions, activities and behaviours that result in SSFFC medical products. This Objective is elaborated in the work plan under Element 5. Element 5(a) states: “Identify the activities and behaviours that result in SSFFC medical products being prevented and controlled due to the health risk they present to the population.” Element 5(b)states: “Identifythe activities and behaviors that fall outside the mandate of the mechanism and separate them from the aforementioned list.”

The second meeting of MSM held on 28-29 November 2013 agreed to a list with regard to Element 5(a) and decided to hold an informal technical meeting prior to the third session of the MSM, to work on India’s paper, which concerned Element 5(b).

According to India’s paper, the rationale for the list identification of actions, activities and behaviors falling outside the mandate of the MSM on SSFFC Medical Productsis to “ensure that unauthorized activities and medical products posing the health risk will face the regulatory actions, while authorized activities/behaviours and medical products not posing the health risks will not face the unjustified regulatory actions”.

The list proposed by India is as follows:

“Actions, Activities and Behaviors that fall outside the mandate of the Member State Mechanism on SSFFC Medical Products and do not result in public health risk

1.      Actions, Activities and Behaviors in violation of laws other than Medical Product regulation such as actions or behaviors in conflict with taxation, duties, custom laws.

2.      Actions, Activities & Behaviors relating to manufacturing, storage, distribution, import and export of medical products, authorized by the National and/or Regional regulatory authority of Medical Products and not leading to medical products failing in quality.

3.      Actions, Activities and Behaviors of licensee/authorization holders involving minor deviations which do not compromise the quality or which  do not pose a health risk , such as minor deviations in  GMP.

4.      Actions, Activities & Behaviors related to medical products, exclusively meant for the purpose of personal use (as consumer or patient).

5.      Actions, Activities and Behaviors which are related to the protection or infringement and enforcement of intellectual property rights including data exclusivity.

6.      Actions, Activities & Behaviors related to medical products meant for the purpose of research and development or for test / analysis.

7.      In the case of medical products in transit, Actions, Activities & Behaviors which may not be in compliance with the regulatory requirements of the country in transit.

8.      Importing, exporting, distributing, including transporting, storing, supplying or selling authorized/licensed medical products from a country to another country where there is no market authorization /license existing for that product in order to meet a national emergency, extreme urgency or humanitarian crisis.”

During a Member State web-based consultation hosted by WHO, the EU proposed additions which in effect gives the EU a right to intercept or seize medical products in transit.  The EU proposed the following text: “In the case of medical products in transit, Actions, Activities & Behaviors which may not be in compliance with the intellectual property regulatory requirements of the country in transit. However, if there are sufficient grounds to suspect that the transiting products are SSFFC or upon request by the recipient country, the Member State through which the products are transiting may intervene”. (Emphasis added.)

The United States also proposed the following text: “In the case of medical products in transit, Actions, Activities & Behaviors related to medical products in transitwhich may not be in compliance with the regulatory requirements of the country in transit, except as they relate to preserving the integrity of the medical product while in transit, such as storage and handling requirements”. (Emphasis added.)

Due to the positions held by the EU and the US the informal meeting could not finalise the text. Several developing countries such as Brazil, India, Bolivia and Argentina have refused to accept the proposals put forward by the EU and the US.  

The draft text currently being discussed by the formal session of the MSM is:

[Actions, activities and behaviours in case of medical products in transit, which are in compliance with the regulatory requirements of the country of export and the country of final destination which may not be in compliance with the regulatory requirements of the country of transit [while preserving the integrity of the medical product in transit] [and except if there are grounds for suspecting the existence of SSFFC medical products]]

The first bracketed text was proposed by the US (“while preserving the integrity of the medical product in transit”), while the second text was proposed by the EU (“and except if there are grounds for suspecting the existence of SSFFC medical products”).

The proposals of the EU and the US in effect allow transit authorities to intercept and seize suspected SSFFC medical products in transit even through there is no violation of any regulatory requirements of both exporting and importing countries.

According to diplomatic sources, the EU in particular has been insisting on the right to intercept.  

In the past, EU authorities have wrongfully seized legitimate quality medicines transiting through some EU ports.  Information obtained by Health Action International (HAI) in 2009 revealed that as many as 17 seizures took place from 2008 to 2009. The actions by the EU authorities unduly hinder timely access to affordable medical products.

The EU is also resisting the proposal to exclude from the mandate of the MSM actions, activities and behaviour concerning minor deviations in relation to good manufacturing practices. According to diplomatic sources, the EU has instead proposed to limit the proposal to “unintentional” deviations.

This is an interesting development because generally regulatory agencies tend to allow minor deviations to be addressed by the manufacturer without any punitive action from the regulatory authorities.  

During the web-based consultation, Switzerland in fact endorsed India’s position. It stated in its online submission that: “We can live with the original sentence … According to us, for inspectors/professionals in this field, it is perfectly clear what is considered a ‘minor deviation’…”

The EU and the US are also further objecting to the title as well as the rationale put forward in India’s paper.

As a result the title of the document is still bracketed,  i.e. “Actions, activities and behaviours that fall outside the mandate of the Member State mechanism [and separated from the list of actions, activities and behaviours that result in SSFFC medical products].  The alternative text proposed for the bracketed part of the text, i.e. “and do not result in public health risk  is also in brackets.

Also in brackets is text clarifying the rationale for the list. It states: [The rationale behind this exercise is to ensure that unauthorized actions, activities and behaviours and medical products posing a health risk will face regulatory actions; whereas authorized actions, activities and behaviours and medical products not posing health risks will not face unjustified regulatory actions.]

The third MSM meeting failed to reach a consensus.+