Article 5. Pharmaceuticals
Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organizations.
237. Article 5 exempts from the application of the Protocol the transboundary movement of LMOs that are pharmaceuticals for humans. LMOs that are pharmaceuticals for humans are principally genetically engineered vaccines (e.g. micro-organisms genetically modified to transmit the hepatitis B vaccine). In order to be exempt, such LMOs must be addressed by other relevant international agreements or organizations. The principal relevant international organization in this area appears to be the World Health Organization.
238. Despite this exemption, Article 5 recognizes the rights of Parties to subject all LMOs to risk assessment prior to any decision on import. – i.e. although the transboundary movement of the LMOs mentioned in Article 5 is not subject to the provisions of the Protocol, Parties may still decide to subject such LMOs to risk assessment prior to import.
239. The exemption in Article 5 refers only to the transboundary movement of LMOs that are pharmaceuticals for humans. Thus, Articles 7, 8, 9, 10 and 12 clearly do not apply to such LMOs. Other provisions of the Protocol, such as those on capacity building and public awareness and participation, however, do apply.
240. The issue of exempting pharmaceutical LMOs from the scope of the Protocol was the subject of much discussion during the negotiations. Early proposals, especially from developed countries, involved expressly excluding pharmaceuticals within the text of the general provision on scope of the Protocol (i.e. what is now Article 4). Many developing countries opposed such proposals, arguing that the general scope of the Protocol should cover all LMOs, but they were amenable to including such an exemption in a separate provision. This accounts for the present structure of Articles 4 and 5.
241. For the Article 5 exemption to be applicable as an exception from the general rule on scope of the Protocol expressed in Article 4, the following elements must be present:
there must be a “transboundary movement” (see Article 3(k));
the transboundary movement must involve LMOs “which are pharmaceuticals for humans”; and
the LMOs concerned must be “addressed by other relevant international agreements or organizations”.
242. The transboundary movement of such LMOs is not subject to the AIA procedure and to the other provisions of the Protocol that are relevant to transboundary movement, except for the right of a Party to subject the LMO to risk assessment prior to import. Other provisions of the Protocol will still apply.78
243. The following categories of LMOs, however, do not satisfy the conditions in Article 5 and will be subject to the Protocol's provisions on AIA and those relevant to transboundary movement, depending upon their intended use (see commentary on Articles 6, 7 and 11):
LMOs which are not pharmaceuticals for humans (e.g. LMOs that are intended for veterinary purposes);
LMOs which are intended to serve as raw material for the production of pharmaceuticals for humans (e.g. genetically modified plants, animals and micro-organisms);
LMOs which are pharmaceuticals for humans but which are not addressed by relevant international agreements or organizations– e.g. those on which no action has been taken as yet under a potentially relevant international agreement or organization.
244. In relation to the last of these elements, the Protocol does not make clear what is meant by “are addressed”– for example, to what extent must the agreement or organization in question explicitly address the issues and activities addressed by the Protocol? Nor does Article 5 specify what would constitute an international agreement or organization for the purposes of satisfying the exemption. While Article 14 of the Protocol allows Parties to enter into bilateral, regional and multilateral agreements and arrangements regarding intentional transboundary movements of LMOs, these must be consistent with the objective of this Protocol and must not result in a lower level of protection than that provided for by the Protocol.
245. The exemption in Article 5 of pharmaceuticals for humans is qualified in that it is without prejudice to the right of any Party to subject the LMO in question to risk assessment “prior to the making of decisions on import”. Thus, Parties may still subject such pharmaceutical LMOs to a risk assessment process prior to allowing the importation. The right of a Party to subject LMOs that are pharmaceuticals for humans to risk assessment is a right which is inherent in every country, which can regulate such LMOs consistent with national standards on human health.
246. While there are relevant international agreements that are applicable to pharmaceuticals for humans, many of these agreements deal with human health concerns but do not yet directly address the environmental and biodiversity impacts of LMOs. A Party may, in the context of a particular import of a pharmaceutical for humans, wish to assess the adequacy of these agreements and require appropriate additional risk assessment as provided for in its national legislation.
78 See Box 10, under Article 1 above, for an analysis of the provisions of the Protocol which are relevant only to transboundary movement of LMOs, and those that apply more generally.
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