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.

Box 21. Why were pharmaceuticals a controversial issue?

Article 5 is the result of intense negotiations in the BSWG meetings and during the Cartagena and Montreal sessions of the ExCOP. During these negotiations, many developing country delegations raised concerns about exempting pharmaceuticals for humans from the scope of application of the Protocol. Some stressed the need for the Protocol to take into account future developments in gene therapy and the use of genetically modified plants and animals to produce pharmaceutical substances, as well as the potential adverse effects of genetically modified pharmaceutical viruses and micro-organisms on human health and the environment. Article 5 clearly applies to pharmaceuticals for humans but not to the use of genetically modified plants and animals to produce them. The cultivation of such plants and the propagation of such animals and their transboundary movement is not exempt under this Article.

Article 5 reflects a compromise formulation, in which only transboundary movements of LMOs which are pharmaceuticals for humans and which, as such, are also subject to other international agreements (see Box 22) or organizations (such as the World Health Organization), will be exempt from the scope of application of the Protocol.

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:

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):

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.

Box 22. Transboundary movement of pharmaceuticals for humans

The cross-border movement of pharmaceuticals for humans in general is governed by the World Health Organization's (WHO) “Certification Scheme on Pharmaceutical Products Moving in International Commerce”. This Scheme is an administrative instrument that is applicable to finished dosage forms of pharmaceutical products intended for administration to human beings or to food-producing animals, and requires the pharmaceuticals regulatory authority of the exporting country to attest to its counterpart in the importing country, upon application by a commercially interested party, that:

The phrase “pharmaceutical products” is defined for purposes of the Scheme above as “any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form or as an active ingredient for use in such dosage form, that is subject to control by pharmaceutical legislation in both the exporting State and the importing State”.

It should be noted that in the Protocol negotiations, many countries initially opposed to exempting pharmaceuticals for humans were reassured by the incorporation of risk assessment in this certification mechanism. It would be necessary to verify whether this is in fact part of the practice in the implementation of the mechanism.

(See WHO, Guidelines on the Implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, http://www.who.int/medicines/teams/qsm/certifguide.html)

The 1970 Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products (“Pharmaceutical Inspections Convention,” available at: http://www.austlii.edu.au/au/other/dfat/treaties/1993/2.html) defines “pharmaceutical product” in Article 1(2) thereof as:

The 1970 Pharmaceutical Inspection Convention provides for mutual recognition of pharmaceutical inspection and quality control standards among the participating States, and promotes the exchange of information related thereto. The “Pharmaceutical Inspection Cooperation Scheme” provides the institutional framework for such information exchange and standards harmonization (available at http://www.picscheme.org/index.htm). The WHO Certification Scheme described above is consistent with the provisions of the 1970 Pharmaceutical Inspection Convention.


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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