E-drug: Note on SA regulations -- PI but not CL
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The following are selections from the new proposed regulations for the
South Africa Medicines Act, which are available on the web here:
http://www.hst.org.za/doh/default.asp
ftp://ftp.hst.org.za/pubs/govdocs/draft/gg22235.pdf
ftp://ftp.hst.org.za/pubs/govdocs/draft/gg22235.doc
Note that the regulations do *not* provide for compulsory licensing --
or for other ways to authorize the import of generic equivalents of
drugs protected by patent in South Africa. This is of course contrary
to a million news reports, which incorrectly and persistently reported
that the court victory over the Medicines Act would permit the South
Africa government to import less expensive generic HIV drugs from India,
China or Brazil. The Act does do quite a bit, including the
authorization of US style generic drug substitution for drugs off
patent, and EU style parallel imports of drugs, regardless of patent
status, as well as sweeping reform of marketing practices and the
creation of a new Pricing Committee that has as its charge the creation
of a transparent pricing system with a single private sector exit price,
an important issue that has not received enough attention. Earlier
proposals for compulsory licensing under 15C of the Medicines Act were
dropped from the regulations, as has been indicated by the Minister and
Directors of Health on numerous occasions.
The Act defines parallel imports as:
parallel importation" means the importation into
the Republic of a medicine under patent in the
Republic that has been put onto the market
outside the Republic by or with the consent of
the patent holder in respect of such medicine.
Note the phrase "by or with the consent of the patent holder." This of
course excludes non-voluntary licenses.
The regulations are out for public comment, and of course, the public
could ask that the regulations be modified, including, for example, by
addition of language on TRIPS Article 31 type compulsory licensing,
although it should be noted that the government has indicated that this
would be more appropriate for amendments to the patent law.
Here are the parallel importation regulations. Jamie
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GOVERNMENT NOTICE
DEPARTMENT OF HEALTH
NO. 480
1 June 2001
A DRAFT FOR PUBLIC COMMENT: GENERAL REGULATIONS IN TERMS OF THE
MEDICINES AND RELATED SUBSTANCES CONTROL ACT (101/1965) AS AMENDED
A DRAFT FOR PUBLIC COMMENT
DEPARTMENT OF HEALTH
DRAFT REGULATIONS IN TERMS OF ACT 101 OF 1965, AS AMENDED
DEFINITIONS
1. In these Regulations any expression defined in the Act bears that
meaning and, unless the context otherwise indicates -
"Act" means the Medicines and Related Substances Control Act, 1965
(Act No. 101 of 1965), as amended;
"
PARALLEL IMPORTATION
7. (1) A medicine under patent in the Republic may be imported into
and disposed of in the Republic if such medicine has been put onto the
market outside the Republic by or with the consent of the patent holder
of the medicine in the Republic subject to the provisions of the Act and
these Regulations.
(2) A holder of a certificate of registration for a medicine in the
Republic shall not be entitled, on account of such registration, to
prevent the parallel importation of such medicine into the Republic and
the disposal thereof within the Republic
(3) A person desiring to parallel import a medicine into the
Republic shall apply to the Minister for a licence to parallel import
such a medicine.
(4) The application to the Minister shall be accompanied by
(a) the price at which the medicine is sold in the Republic by the
holder of the certificate of registration;
(b) the price at which the medicine is intended to be sold in the
Republic by the parallel importer;
(c) a declaration by the parallel importer that the medicine to be
parallel imported is a medicine under patent in the Republic;
(d) any other information the Minister deems necessary.
(5) After being issued with a licence to parallel import a medicine
the parallel importer shall apply to the Council to register the
medicine.
(6) The Council shall only register the medicine if the parallel
importer-
(a) has been licenced by the Minister to parallel import the
medicine;
(b) has a registered office in the Republic;
(c) has a storage facility approved by the Council for such
medicine;
(d) has a responsible pharmacist as required in terms of the
Pharmacy Act, 1974;
(e) undertakes to be responsible for ensuring that such medicine
meet the safety, quality and efficacy standards as determined by the
Council;
(f) has in place recall procedures as determined by Council, and
(g) complies with any other conditions as the Council may determine.
(7) An application referred to in subregulation (5) shall be
(a) submitted to the Registrar;
(b) made on a form and accompanied by information as determined by
the Council;
(c) accompanied, by a fee determined by the Council; and
(d) considered and a decision made within the period(s) as
determined by the Council.
(8) An application for the registration of a medicine to be parallel
imported must be accompanied by:
(a) proof of registration of the medicine in the country of export;
(b) copies of the package insert, where applicable, for approval by
the council translated into English and verified;
(c) copies of the sample with appropriate labelling and scheduling
of such medicine;
(d) proof that the final product is safe, efficacious and complies
with all quality requirements and specifications as determined by
council;
(e) certificate of supplier accreditation in the country of export;
(f) information on the exporter's status, whether it is the original
manufacturer, broker, packer, re-packer; and
(8) identity and assay of the medicine.
(9) The Council may require a person who applies for the
registration of a medicine in terms of this regulation to submit to it
relevant test data or samples in respect of such medicine.
(10) Medicines that are parallel imported shall be labelled,
packaged and have package inserts and patient information leaflets as
prescribed in terms of regulations 9 and 10.
(11) The person parallel importing a medicine into the Republic
shall, in the interest of public health, be entitled to use the South
African name and trademark of such medicine, even though the medicine
was marketed outside the Republic under a different name or trademark:
Provided that the name is approved by the Council.
(12) Council may, if it is satisfied with an application in terms of
this regulation, approve the registration of such medicine as a parallel
imported medicine.
(13) A person issued with a licence to parallel import a medicine in
terms of this regulation shall within 14 days after such medicine has
been registered, inform the holder of a certificate of registration in
the Republic of such fact.
(14) The registrar shall keep a separate register of medicines
registered in terms of this regulation.
(15) The registrar shall publish in the Gazette the names of persons
issued with a license to be a parallel importer, and any other
information as the Council may determine.
(16) A licence issued in terms of this regulation is valid for a
period not exceeding one year and may be renewed if an application for
renewal is approved by the Minister.
(17) A parallel importer of a medicine shall
(a) not sell or dispose of such medicine unless such medicine is
registered in the Republic;
(b) only parallel import the medicine from manufacturers;
distributors or wholesalers who are duly licensed in the country of
exportation by the medicines regulatory authority that is recognised by
the Council;
(c) inform the Council within 30 days of any change of conditions
under which the licence was issued, including any material changes to
storage conditions, any change to the particulars of the medicine, and
the cessation of parallel import activities;
(d) ensure that person(s) in charge of premises where the medicine
is stored are appropriately qualified;
(e) maintain proper transaction records;
(f) report to the Council any adverse drug reactions or any other
risks associated with such medicine that might affect its quality,
safety or efficacy; and
(g) maintain emergency action plans for addressing any adverse drug
reactions.
(18) The Minister may, on good cause shown, revoke the licence to
parallel import a medicine.
(19) The Council may, on good cause shown, revoke the registration
of a parallel imported medicine.
--
James Love
Consumer Project on Technology
http://www.cptech.org
1.202.380.3080 fax 1.202.234.5176
mailto:love@cptech.org
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