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SEC - Question 1: What is your understanding of “a decision on import”? How do you understand its scope? Does it matter whether a decision is taken under the Protocol (Article 10) or under domestic measures implementing the Protocol?

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Question 1: What is your understanding of “a decision on import”? How do you understand its scope? Does it matter whether a decision is taken under the Protocol (Article 10) or under domestic measures implementing the Protocol? [#4494]
Dear All,

First of all I would like to thank to Ms. Paola Scarone, for the coordination of this working group and for the question for the discussion.

Through tracking the forum discussions comments, I have gained more understanding on decision import of LMOs which are related to the socio-economics consideration. It is the importance for the member counties to the CPB to make the decision carefully on how it harm or benefit their socio-economics situation.

I have one question related to the GM pharmaceutical, that I just wonder that is why it is not in decision imports of the CPB's scope. I would like to apology if my question is too late for the forum discussion.

Thank you.

Best Regards,
Ratanak Mun
BCH Focal Point,
NSCB, Ministry of Environment
Cambodia
posted on 2013-03-17 17:04 UTC by Mr. Mun Duong Ratanak, Cambodia
SEC - Question 1: What is your understanding of “a decision on import”? How do you understand its scope? Does it matter whether a decision is taken under the Protocol (Article 10) or under domestic measures implementing the Protocol? - A new message ha... [#4499]
Dear participants,

I would just like to try to partially answer the question of Mr. Mun Duong Ratanak, from Cambodia, in his posting n° 4494.

Art. 5 of the Protocol says that : “ ……….. this Protocol shall not apply to the transboundary movement of LMOs which are pharmaceuticals for humans that are addressed by other international agreements or organizations. “

I must confess that I do not know all the international agreements or organizations that would address the adequate concerns, but obviously pharmaceuticals, including LM pharmaceuticals, are covered by specific legislations.

But the same article of the Protocol in any case is starting by: “ ………. without prejudice to any right of a Party to subject all modified organisms to risk assessment prior to the making of decisions on import……..” , which means that Parties may elaborate particular domestic measures relative to GM pharmaceuticals, which the exporters would have to respect, even if other international agreements or organizations already address some safety aspects relative to this kind of LMOs.

For ex., in the EU, whereas a specific legislation covers the health safety aspects of medicinal LMOs ( like health safety aspects are assessed for other medicines ), these LMOs ( often containing genes or parts of genes or genetic promoters of viruses or bacteria ) have to go through the risk assessment procedure of directive 2001/18/CE - relative to deliberate release into the environment of LMOs - to assess their potential risks for the environment.

Besides that, I totally agree with a previous posting ( that I don’ t succeed in finding back ) of a participant – reacting to my 1st posting – saying that the Protocol applies to GM pharmaceutical plants, that are indeed not yet pharmaceuticals themselves but are development tools for pharmaceuticals.

With kind regards.

Lucette Flandroy

Disclaimer : http://www.health.belgium.be/eportal/disclaimer/
posted on 2013-03-17 18:40 UTC by Ms. Lucette Flandroy, Belgium