Transcript Macdonald Netshitenzhe Patent Flexibilities

Overview: The South African IP
Policy Review
13 September 2012
MacDonald Netshitenzhe: Chief
Director- Policy and Legislation
Background
• The IP system is one of the factors that directly and
negatively/positively impacts on access to healthcare. Other
constraints to access to medicines/drugs in developing countries
are amongst others, lack of resources (skilled personnel, funds
and time) and the absence of a suitable health infrastructure, e.g.
hospitals, clinics, health workers, equipment and adequate
distribution/supply of drugs to administer medicines safely and
efficaciously. Nevertheless, a developing country like South Africa
may develop and adopt other national policies that can directly
affect the direction of access to medicines, e.g. taxes on
medicines.
• Compulsory licensing may also be of assistance as a bargaining
tool in price negotiations with producers of patented medicines
e.g. the United States envisaged this possibility when negotiating
the price of cipro (a drug) following the anthrax attack after
“9/11/2001” (9/11).
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• There should be a balance between trade and health issues in
relation to patents and IP protection. During the Doha trade
negotiations access to public health and IP was eminent on the
agenda.
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 Access to medicines has been debated and concluded at the
WTO during the Doha Round of Talks of the Development Agenda
(Doha Development). A Doha Decision (Paragraph 6) was taken
that gives countries the right to access medicines. Compulsory
licensing should be introduced in South Africa in line with
international treaties such as Doha Decision 6. Patents Act will
be amended in order to facilitate this.
 One of the options is to allow countries with no manufacturing
capacities to issue a Compulsory Licence against an existing
patent. A country with manufacturing capacity can manufacture on
behalf of other countries and deliver such under a secured
environment. Such drugs should not be diverted to unintended
destinations. The WTO Council should be notified. Canada has
passed a legislation that allows it to manufacture drugs under this
scheme. Compulsory Licensing under the current Patents Act is
cumbersome and cannot assist in accessing to medicines.
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 Voluntary Licensing mostly happens when innovators license
third parties such as generic companies to produce drugs under
agreed terms. In South Africa Voluntary Licensing is taking place,
in particular after the “Parallel Importation case” between the
Government and the 39 Pharmaceutical Companies.
 Parallel Importation of drugs is allowed under the Medicines
Control and Substances Act, but not under the Patents Act. The
Trade Marks act should also be amended to allow parallel
importation.
 Competition Act has been used to force innovators to license
third parties to produce drugs.
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• Other issues that fall outside IP regime need to be addressed, e.g.
Manufacturing capacity, Distribution of drugs and Pricing of
drugs, creation of competition in the market place by applying
competition legislation. In this regard, there is a need to undertake
an advocacy role to the department of Health.
• Section 4 of the Patents Act allows expropriation of a patent to
take place.
Substantive Search and Examination of Patents
• It is said that the depository system of Patents at CIPC leads to
weak patents being granted. It is planned that a dual system be
utilised, being both the depository system and substantive search
and examination with special focus on areas that SA is strong in ,
e.g. Pharmaceuticals, Machinery, Chemicals etc
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Data Protection
• Article 39 of TRIPS provides for the mandatory data protection for
both pharmaceutical and agricultural chemical entities. SA should
invoke this by undertaking legislative amendments to the
Medicines and Substances Control Act and the Health
Practitioners Act, etc.
Patent Restoration and/or extension.
• Regulatory delays during clinical trials at the (MCC)MRA tend to
encroach on the lifespan of a patent thereby limiting the time for
exploiting the patent. Other jurisdiction allow the extension, case
in point, the US. SA is not intending to extend the patent
protection period unless harmonization takes place the world over.
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Counterfeit Medicines and Generic medicine
• Generic medicines are not counterfeit as they are a result of
expired patents and these should be treated not as adulterated
medicines.
• Policy space allows the working on an unexpired patent to be
done on in order to produce a generic drug as long as that drug is
not sold/marketed while patent protection subsists in the other
drug.
• Generic medicines that are transshipped through developed
countries get to be confiscated under the pretext that they are
counterfeit. SA does confiscate goods (Generic medicines) in
transit as it views them as legal products that are not
counterfeited. IP is territorial in nature !
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Trademarks and labeling
• After a patent has expired the name of the manufacturer’s
company should not be on the label of the expire drug as this has
a tendency to have an unfair advantage over the generic medicine
manufacturer in the market place.
Trade agreements (BITS)
• BITS that will undermine the discretionary measures( Flexibilities
and exceptions) that are allowed in multilateral agreements such
as TRIPS should not be entered into by SA. These agreements
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Trade secret
• Trade secrets are a customary way of protecting technological
innovation. Confidential commercially valuable information is
protected as long as reasonable steps to protect the information
are taken and there is no disclosure – trade secret will subsist
• SA should allow the co - existence of trade secrets with the IP
system and users should have a choice of which system to use.
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END
END
THANK YOU
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