Transcript Inception Report Presentation - Trade, TRIPS and Access to Medicines

ASSESSMENT OF THE STATUS OF
IMPLEMENTATION OF TRIPS FLEXIBILITIES IN
BOTSWANA
26th March 2013

Examine the extent to which public health related TRIPS
flexibilities have been incorporated into relevant national
legislation:

Interrogate policy strategies in place to allow Botswana to
achieve a balance between international commitments to
protect IPR and public health obligations relating to sustainable
access to ART and identify further steps:

Interrogate the effectiveness of drug and diagnostics
procurement processes currently used by Botswana for the
national ART Programme from a cost benefit analysis perspective
of the TRIPS:

To exploit the dynamics around the use of the TRIPS by various
actors in Botswana.

Desk review of the relevant legal and policy
instruments governing the public health aspects of
the TRIPS in Botswana:

Literature review of the TRIPS and public health
debates. This tool will also be utilised to identify and
assess
comparative
experiences
on
the
implementation of TRIPS flexibilities in the SSA region
and elsewhere, e.g. South Asia.

Input/Discussions with the Reference Group from
key stakeholders, policy makers, and practitioners in
the fields of IPR, public health, medical drugs
procurement, production and distribution, and
international trade; and
 Global
pharma R&D intensive- efforts &
profits protected by patents:
•
•
•
•
Patents granted to protect inventions (prevent
others from misappropriating creation for
SPECIFIC period):
Invention refers to any product, process or
improvement which is NEW, NOT OBVIOUS to an
ordinary person, and useful to society (TRIPS
art.27).
Patents are IPRs protected by the WTO TRIPS
Agreement and domestic legislation (Industrial
Property Act).
Working within IPRs has cost implications.
World’s Largest Pharma (2010)
 Africa
represents only 1.3%of global market;
 BUT SSA market worth US$3.8 billion (IFC,
2008)



30% of this LOCAL FINAL FORMULATIONS
Dominated by South Africa (70%)
Nigeria, Kenya, Ghana (20%)
 US$3B
will be invested in SSA health sector
2007-2016:

40%
in
GENERIC
FINAL
MANUFACTURING(IFC, 2008)
FORMULATION
Number of Manufacturers:
45
40
35
30
25
20
15
10
5
0
 Sub-Saharan
Africa pharmaceutical
market to be worth US$3.8 billion.
 37 Sub-Saharan African countries
have
some
pharmaceutical
production, South Africa dominates
the sector with over 70 percent of
the region’s annual pharmaceutical
production.
 Botswana has no pharma producers.
 2001
Abuja Declaration (15% of
budget to health)
 WHO 2000 Health Report est. $60
per capita for comprehensive health
system.
 WHO
High Level Task Force (2009)
recommended $54 per capita to
meet health related MDGs
Burundi
DRC
Liberia
Guinea-Bissau
Ethiopia
Gambia
Malawi
Sierra Leone
Eritrea
Rwanda
Niger
Uganda
Tanzania
Togo
Madagascar
CAR
Mozambique
Guinea
Burkina Faso
Mali
Lesotho
Chad
Ghana
Benin
Nigeria
Kenya
Senegal
Zambia
Mauritania
Côte d'Ivoire
Cameroon
Sudan
Zimbabwe
Congo
Swaziland
Namibia
Angola
Mauritius
Gabon
Botswana
Health expenditure ($US, 2007)
Position of Botswana:
$100
Government spending
$90
$80
$70
$60
WHO target ($54)
$50
$40
$30
$20
$10
$0
<$250
$250-$499
Sources: WHOSIS database, IMF World Economic Outlook 2007, and author’s calculations
$500-$999
Country, sorted by per capita GDP in 2007
$1000+
 Public
sector predominant provider
of care
 80%+
receive care from public
sector (RNHP, 2011)
 Nominal
Cost Recovery
 Resolution
WHA60.30 of May 2007:
Requested the Director-General "to provide…
in collaboration with other competent
international organizations, technical and
policy support to countries that intend to
make use of the flexibilities contained in the
agreement on Trade-Related Aspects of
Intellectual Property Rights and other
international agreements in order to
promote access to pharmaceutical products"
Access to essential medicines is a human right;
• Essential medicines are not simply another
commodity, TRIPS safeguards are crucial;
• Patent protection has been an effective
incentive for R&D for new drugs;
• Patents should be managed in an impartial way,
protecting the interests of the patent-holder, as
well as safeguarding public health principles;
and
• WHO supports measures which improve access to
essential medicines, including application of
TRIPS safeguards.
 See too AU Roadmap (Pharma Plan)

 2006
UN General Assembly Political
Declaration on HIV/AIDS:
find “appropriate solutions to overcome
barriers in pricing, tariffs and trade
agreements, and to making improvements to
legislation, regulatory policy, procurement
and supply chain management in order to
accelerate and intensify access to affordable
and quality HIV/AIDS prevention products,
diagnostics,
medicines
and
treatment
commodities.”

 UNDP
(2010)
Good Practice Guide:
Improving Access to Treatment by Utilizing
Public Health Flexibilities in the WTO TRIPS
Agreement provide a critical international
policy guideline and reference point.
 AU (2007) Pharmaceutical Manufacturing
Plan for Africa (the Plan).

6 PRIORITY AREAS (INCLUDES IPRS)
 The
SADC Pharmaceutical Business Plan
(2007-2013)
KEY SADC STRATEGY:
“Collaborate
with
development
partners to enable countries to
protect, include and take advantage
of the flexibilities that exist in the
TRIPS Agreement as well as to assist
countries
in
bilateral
trade
negotiations
to
conclude
agreements
that
are
not
detrimental to public health.”
 VISION
2016- PILLAR 3; Compassionate,
Just & Caring Nation:
 NDP 10 – GOALS 8-9 aim to achieve:
 Affordable and Quality Healthcare; and
 Prevent new HIV/AIDS infections.
 REVISED NATIONAL HEALTH POLICY(RNHP,
2011)
 National Trade Policy
 TO
EXPLORE POTENTIAL FOR LOCAL
PRODUCTION THROUGH
COLLABORATION WITH OTHER
COUNTRIES:
 TRANSFORMATION OF LOCALLY
AVAILABLE MEDICINAL PLANTS INTO
INDUSTRIALISED MEDICAL PRODUCTS:
 REGULATORY REFORM (DRUG
REGULATORY UNIT TO AUTONOMOUS
INDEPENDENT BODY.
 STRENGTHEN NATIONAL DRUG QUALITY
CONTROL LABORATORY.
“Government
ensures that Intellectual
Property Rights protection functions as a
stimulus for innovation and technology
diffusion. Government is committed to
the protection, recognition and equitable
sharing of intellectual property rights
trade benefits in line with her national
and international commitments.”
Horizontal
Cartels:
Through
licensing
agreements that fix prices, limit output, or
divide markets.
 Raising Barriers to Market Entry: e.g. Tie-in
sales of protected product and another product,
competitor forced to enter both markets hence
raising costs.
 Predatory Behaviour:
 Purchasing exclusive rights with no intention of
using them
 Bad
Faith
Litigation:
damages
SMALL
ENTERPRISES.
 PAY-FOR-DELAY
DEALS
(USA)
(patent
challenged, generic maker wants to launch
before expiry)

Extending
Patent Terms
Restricting Patent Opposition
Forbidding
generic licensing
where there is a valid patent.
Limiting
Compulsory Licenses
only to cases of national
emergencies.
Limiting Parallel Imports.
Industrial
Property Act (2010)
 31st
August 2012 through SI70
of 2012
 Industrial Property Act
Regulations.
Impact
of relevant FTAs
 Patentability
Criteria
 Exclusion from Patentability
 Patent Opposition
 Patent Examination
 Parallel Imports
 Exceptions
 Compulsory Licences
 Use of Competition Law
 Enforcement
NB See Legal Analysis in the Detailed Report.
 Section
8 adopts the minimum standard as
defined under art.27(1) ( new, involves an
inventive step, and is capable of industrial
application ).
 Not precise enough to prevent
“evergreening”.
 The fact that the Act provides room for pre
and post patent grant challenges may
provide some degree of vigilance over
evergreening. NB CAPACITY REQUIRED.
 The
Act goes beyond the TRIPS Agreement by
clearly adding other grounds for excluding
patentability. NOT patentable in Botswana:





a discovery or a plant, animal, micro-organism or
substance as found in nature, including the
human body;
a scientific theory or mathematical method;
a literary, dramatic, musical or artistic work or
other aesthetic creation;
a scheme, rule or method for doing business,
performing a mental act or playing a game;
a computer program.
 Follows
UNDP Good Practice Guidelines
makes provision for both pre-grant and postgrant patent opposition, section 36(1)
complements s21(5) by permitting any
interested party to make an application
(either to the Registrar or to the High Court)
to invalidate a patent already granted by the
Patent Office).
 NB OMISSION to make substantive provision
for process of making such challenges in the
Regulations (But objection procedure for
trademark registrations provided for).
 Section
22(1) of the Act gives the Registrar
powers to examine an application for a
patent for compliance with the Act before
deciding whether or not to grant a patent.
 But
s22(2):“The
Minister
may,
by
regulations, prescribe the categories of
inventions in respect of which an
examination under this section shall not
cover the requirements of novelty and
inventive step”.


Lowers the patentability criteria created under
section 8 and the TRIPs Agreement!
Difficult to object to such a patent grant.
 Permissible
under s25(1) where the patented
article is put on the Botswana market or
abroad by the patentee or by another person
acting with the patentee’s consent, or having
an economic tie to the patentee.
 Ten
specific exceptions which enable the
exploitation of a patent are provided for
under s25(1).

The Act has provisions for the issuing of compulsory
licences under 3 scenarios.
Compulsory licences in the public interest or for competition
(s31),
 For importation of patented products by Government or a
third party (s32).
 For failure to exploit a patent (s33). The Act hence makes use
of the TRIPS flexibilities and also goes as far as incorporating
the August 30 Decision/article 31 bis of the TRIPS Agreement
(see sections 31(3), 32(2), and (4). But see further below on
the status of competition law and institutions with respect to
IPRs in Botswana.


The 30 August Decision introduced a waiver of the
requirement of Article 31(f ) for predominant domestic use
and purported to provide a mechanism that allows WTO
Member States to issue compulsory licenses for export of
generic equivalents of patented medicines to countries
with no pharmaceutical manufacturing capacity, or
insufficient capacity.




Industrial Property Act:
The issuance of a compulsory licence by the Minister where a
court or administrative body has determined that the manner of
exploitation of the invention by the patentee is anti-competitive
or constitutes an abuse of the patent (s31(1)(b).
The issuance of a compulsory licence by the Minister where a
competition authority has determined that the manner of
exploitation of a patent in the field of semi-conductor
technology is anti-competitive (s31(11); and
Acts of unfair competition; where at the request of the owner of
a title of protection under this Act, or of any competent
authority or any person, association or syndicate, the court may
grant an interdict to prevent an act of unfair competition, award
damages or grant any other remedy as the court may deem
appropriate (s114(1)). Section 114(2) provides an inclusive list of
acts that may constitute unfair competition, these acts are
largely to do with trade matters, e.g. passing off, unfairly
discrediting a competitor, misleading claims etc. VERY LIMITED
SCOPE.
 Competition
Act: Section 25-26 provides for
detailed
treatment
of
prohibited
RESTRICTIVE PRACTICES and abuses of
DOMINANT POSITIONS.
 BUT: does not apply, s3(b) thereof to-“any
agreement to the extent that the agreement
relates to the protection, exercise, licensing
or assignment of rights under any law
governing intellectual property rights.”
 IPR law limited scope, Competition Act not
applicable.
TRIPS Agreement (art.61) requires members to
criminalise at least cases of wilful trademark
counterfeiting or copyright piracy on a
commercial scale. Act provides so.
 BUT s134(4) (NB error on s24/25 ref) of the Act
creates
a criminal offence for patent
infringements in Botswana. This is a TRIPS-Plus
provision.



NB USA FED COMMISSION 2010 STUDY- 30% of disputed
patents ruled INVALID after litigation:
RBC Capital Markets Corp. of 371 cases during 20002009 found brand-name companies won 89 at trial
compared to 82 won by generic drug makers.
 Who
prosecutes?
 Who
is prosecuted?
 At
what cost?
 At
whose cost?
 Then
what????
Ideal Framework
Related
Internat
ional
Policies
TRIPS
Agreem
ent
Compet
ition
Act
ART Programme
FTAs
Industri
al
Propert
y Act
Related
Domesti
c
Policies
 Motivations
 SACU-USA
 SADC-EC-EPA
 SACU-EFTA




FTA
Art.26- Harmonisation of IPR
EC Supplementary Protection Certificate for
Medicinal Products (NORWAY implemented)
European Patent Organisation & Convention
2014 Convention Unitary Patent System
The Current Reality
TRIPS
Agreement
Related
International
Policies
Other FTAs
Competition
Act
SACUEFTA
FTA
Industrial
Property Act
ART
Programme
Related
Domestic
Policies
 One
strategy for price reductionLOCAL PRODUCTION:
 Option:
POOLED PROCUREMENT
 MIXTURE
OF BOTH
 REQUIRE
ENABLING ENVIRONMENT
“The African Union argues that domestic drug
production
develops
the
appropriate
industrial and technical infrastructure that
can enhance long-term health security, selfsufficiency, employment, foreign exchange,
in addition to access to essential medicines.
 In
other words, local manufacturing
potentially can bring economic and symbolic
gains to a country.”
“In the policy context (Revised
National Health Policy), the Ministry
of Industry and Trade has been
tasked with “collaborating with the
Ministry of Health to promote the
establishment of pharmaceutical
and
biomedical
manufacturing
companies in Botswana”.
 Government
considered domestic production
as a means to scale up treatment
 Local manufacturer Tanzania Pharmaceutical
Industries (TPI) entered an agreement to
produce a triple FDC 17 of first-line ARVs

TRIPS provisions offer governments the ability to put health
before trade objectives, but many developing countries and
LDCs simply cannot utilize these provisions is reinforced.

Barriers in administration, politics, policy, and capacity limit the
use of TRIPS flexibilities in LDCs.

Successful technology transfer arrangements and manufacturing
initiatives require long-term coordination and planning across
health, industrial, and science and technology sectors.

Efforts to develop industry will have great difficulty in
succeeding if driven entirely by the health sector.

The need to address adequate economies of scale of [QA =
quality assured?] production must be established from the start in
the initial business plan
 Government
put in place critical
REGULATORY FRAMEWORK:

Requires some enhancements (see
recommendations)
 POLICY

FRAMEWORK in place:
Requires alignment with sector and multi-sector
policies (see recommendations)
 Government
supportive of private sector
initiatives.
 Scope for REGIONAL collaboration exists:

Bilateral, Sub-regional etc.
SUBJECT
CONTEXT
ENABLING ENVIRONMENT
INDUSTRIAL PROPERTY ACT
COMPETITION ACT
TRADE POLICY
TRIPS FLEXIBILITIES &
NEGOTIATING POSITIONS (E.G.
SACU-EFTA FTA)
STAKEHOLDER LIAISON
OPTIONS FOR DRUG
PROCUREMENT
FEASIBILITY OF LOCAL
PRODUCTION
POOLED PROCUREMENT
INSTITUTIONAL STRENGTHENING
REGULATORS & RESEARCH AND
DEVELOPMENT
 1:There
is need to ensure that patent
examiners develop a stringent criteria for
the application of s8 in the context of
applications for secondary patents. This
requires constant capacity building at the
Marks, Patents and Designs Office (the
Patents Office):
 2:The additional grounds for exclusion of
patentability add stringency to the
patentability criteria and this is a positive
use of the policy space that Botswana has
in the context of the TRIPS flexibilities and
this should be maintained.


3:Amend the Regulations by providing for a section
along the lines of s41 to cover the process for the
filing of objections to applications for patents. If
costs are to be provided for in the regulations they
should not be too prohibitive (thus discouraging
serious challenges) or too low (thus encouraging
frivolous challenges).
3.1.: Capacity Building:



Capacity building seminars, training workshops etc on
the key aspects of the patent regime, its links with
the public health concerns of the country, and its
potential to enhance Botswana’s development plans.
Demystifying the whole concept of patents through
regular media interactions with the public.
Training media practitioners in order to increase the
level of awareness on patents and health
4: Section 22(2) is a substantive drawback to
an otherwise positive Act, it should be
repealed.
 5:repeal s134(4), or the very least to conduct
an in-depth review, and question the
assumptions upon which this provision is based
in the context of Botswana’s development
needs.
 6: Section 3 (a) of the Competition Act should
be amended to create a more holistic approach
to dealing with anti-competitive practices in
the IPR system in general.

 7:
SACU-EFTA FTA NEGOTIATIONS: Align the
IPR issues under the SACU-EFTA FTA with:
The Revised National Health Policy;
 The National Trade Policy;
 The TRIPS flexibilities adopted within the
Industrial Property Act; and
 Botswana’s negotiating position on the traderelated issues under the negotiations for the
comprehensive EPA with the EU.

 8:

MOH, NACA, ELHR STAKEHOLDERS:



STAKEHOLDER LIAISON
TRAINING IN NATIONAL TRADE POLICY:
STRONG, REGULAR AND SUBSTANTIVE PARTICIPATION IN
NATIONAL TRADE POLICY IMPLEMENTATION
MECHANISMS
MOT, DIT, IPR REGULATORS, COMPETITION
REGULATORS:


JOINT TRAINING IN NATIONAL HEALTH POLICY
PRIORITIES
LINKAGES BETWEEN TRIPS FLEXIBILITIES & HEALTH
PRIORITIES TO BE EMPHASISED.
 6:
Section 3 (a) of the Competition Act
should be amended to create a more
holistic approach to dealing with anticompetitive practices in the IPR system in
general: Example of suggested amendment:
“This Act does not limit any right under any
law governing intellectual property rights
except to the extent that such a right is
used in a manner that is inconsistent with
Part V of this Act.”
 9:
Institutional Strengthening; The
Industrial Property Act does not create a
new regulatory authority for patents, the
Marks, Patents and Designs Office
established by the repealed Industrial
Property Act, Cap 68:03 still exists. New
cost implications may arise from the
nature of regulatory powers assumed by
the Registrar.



Technical Expertise;
Technology.
Legal Reforms.
 10:Support
to technical aspects of
the National Health Policy’;
 Feasibility Study for Local
Pharmaceutical Production;
 Feasibility Study for Pooled
(Regional) Procurement in the
context of the SADC
Pharmaceutical Business Plan.
 ……../THANK
YOU