EU pushing for a right to intercept medical products in transit

Source: Third World Network

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 transit*which 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 is expected to resolve the deadlock.+

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