[Ip-health] The Union for Affordable Cancer Treatment (UACT) and 22 NGOs working on cancer in South Africa filed comments on the South Africa Draft Intellectual Property Policy

James Love james.love at keionline.org
Wed Oct 11 06:13:26 PDT 2017


The UACT submission included several recommendations to implement the
proposed policy for South Africa in the area of patents and medical
inventions.

Jamie


https://cancerunion.org/2017/10/10/uact-and-22-cancer-treatment-ngos-submit-comments-on-south-africa-ip-policy/

On October 10, 2017, UACT and 22 NGOs working on cancer in South Africa,
submitted comments to the South Africa on the Draft South Africa IP Policy.

The text of the submission follows:

October 10, 2017

The Honorable Dr. Rob Davies Minister of Trade and Industry
77 Meintjies Street Sunnyside,
Pretoria, Gauteng, South Africa

Re: Draft National Policy on Intellectual Property

Dear Minister Davies,

We write to you on behalf of the Union for Affordable Cancer Treatment
(UACT), a union of people affected by cancer, their family members and
friends, people who take care of people with cancer, health care
professionals and cancer researchers committed to increasing access to
effective cancer treatment and care. UACT is particularly concerned about
the rapidly escalating cost of cancer medication and seeks to fight for
cancer treatment and care to be affordable and available, everywhere, for
everyone who needs it.

UACT wishes to offer some brief comments on the Draft Intellectual Property
Policy of the Republic of South Africa, Phase I 2017, specifically with
regard to IP and health. We appreciate that the draft takes positive steps
but would like to see South Africa go further in implementing policies that
make “access to medicines for all” a reality.

There are many proposals in the policy that we were pleased to see,
including:

* Recommendations on the introduction of a substantive search and
examination (SSE) approach; improved patent opposition mechanisms; and the
adoption of patentability criteria “that address the country’s public
health and environmental concerns, as well as industrial policy objectives.”

* Positive language on the important role of voluntary licensing, with
particular emphasis on the transparency of terms and conditions in such
licenses as exemplified by the Medicines Patent Pool.

* Recommendations on the use of compulsory licensing reflecting steps
needed to make the process more streamlined and less encumbered by a
litigation process; government use licenses as a viable legal tool relevant
to the state’s obligation “to take reasonable legislative and other
measures to progressively realize the right to have access to health care
services…[including] the utilization of TRIPS flexibilities such as Article
31 (b), in full accordance with South African law;” and engaging with WTO
to streamline the cumbersome Paragraph 6 mechanism on compulsory licensing
for export.

* Recognition of the importance of multilateral cooperation, particularly
noting the work at the WHO on addressing “issues such as lack of
affordability, limited research where market returns are small or uncertain
. . “   and noting delinkage as among the core principles of the WHO
Consultative Expert Working Group.

UACT notes the use of TRIPS flexibilities and the principle of delinkage
were recommended as key strategies to improve policy coherence in the UN’s
2030 Agenda for Sustainable Development and in the 2016 Report of the UN
High Level Panel on Access to Medicines.

UACT is concerned that South Africa has not acted to induce non-voluntary
licensing of drug patents since 2003 in the Hazel Tau case, and that case
involved the independent RSA Competition Commission, rather than an
executive agency.

While we applaud and support the idea of streamlining the process, we also
suggest the grounds for licensing should include some that are mandatory,
so the compulsory licensing process is self executing when a need is
presented.  One benefit of a mandatory compulsory licensing ground is that
the RSA government officials could not be pressured or lobbied to withhold
a license, since the policy to issue the compulsory license was automatic
if the grounds themselves are satisfied.  An example of a mandatory
non-voluntary authorization is the U.S. U.S. Biologics Price Competition
and Innovation Act of 2009, which eliminates the possibility of an
injunction for infringement when the patent holder fails to provide timely
constructive disclosure of the patent landscape on biologic drugs, or
Section 92A of India’s patent law, which provides that

“Compulsory licence shall be available for manufacture and export of
patented pharmaceutical products to any country having insufficient or no
manufacturing capacity in the pharmaceutical sector for the concerned
product to address public health problems. . . ”  [emphasis added].

Here we suggest one of two approaches for consideration.  The first is a
non-voluntary authorization to use an invention in the context of Article
31 of the WTO TRIPS agreement:

Option 1, as an exception to the exclusive right

Non-voluntary use of patented invention in the field of use of a drug,
vaccine or other medical technology shall be allowed, subject to the
payment of a reasonable and affordable royalty, whenever a drug or vaccine
is not available at a price that is reasonable and/or affordable for the
general population or any significant group of potential patients, and
there is evidence that access is limited due to the price.  A decision that
the price for a product is not generally reasonable and/or affordable can
be made either by the Ministry of Health, the premiers of any provinces,
the South Africa Competition Commission, or by any judge in a lower court.


The second approach is similar, except that it is framed as a limitation on
remedies, under Article 44.2 of the TRIPS.  The advantage of the second
approach is that avoids the restrictions in the WTO relating to Article 31
of the TRIPS, such as a requirement for prior negotiation on reasonable
commercial terms and condition, and it does not limit exports.  The
limitation on remedies is the approach taken in the U.S government use
statute (35 USC 1498) and the U.S. Biologics Price Competition and
Innovation Act of 2009 and the dozens of compulsory license that have been
issued in the United States by the courts in the context of the enforcement
of infringements.

Option 2, as a limitation on the remedies for infringement

The remedies for infringement of a patent on an invention in the field of
use of a drug, vaccine or other medical technology shall be be limited to
the payment of a reasonable and affordable royalty, whenever a drug or
vaccine is not available at a price that is reasonable and/or affordable
for the general population or any significant group of potential patients,
and there is evidence that access is limited due to the price.  A decision
that the price for a product is not generally reasonable and/or affordable
can be made either by the Ministry of Health, the premiers of any
provinces, the South Africa Competition Commission, or by any judge in a
lower court.


We believe option 2 is best, although either approach would be a vast
improvement on the current law.

In addition, as part of the streamlining of the procedures, UACT recommends
South Africa adopt royalty guidelines for non-voluntary licenses,
considering, for example, the 2005 WHO and UNDP royalty guidelines as a
model.

One of the topics not discussed in the Draft Policy concerns transparency,
particularly as it relates to the management of intellectual property
rights and the economic factors that are relevant to the pricing of
medicines, vaccines and other medical technologies.

As one country, the RSA has limits on the leverage it can exercise to
ensure transparency, but there are measures it can take, and the government
can also work with others in fora such as the World Health Organization to
promote standards on transparency.

At a national level, the RSA could require the following transparency
measures,  all of which are designed to public and to benefit and inform
the general public.

1. An annual reporting of  yearly and cumulative sales earned by every drug
or vaccine registered for sale in the RSA market that does not face
competition from a generic product.

2. For each new drug registered in the RSA, the amount of money spent on
each clinical trial used to justify the registration of the drug, and all
public subsidies including tax credits that were relevant to each trial.

3. The patent asserted for every drug or vaccine, including an explanation
of how each patent is relevant to the drug, making a failure to disclose
sanctioned by an elimination of damages or inductions, as in the U.S.
Biologics Price Competition and Innovation Act of 2009.

4. Require transparency of all royalty patents on patents granted in RSA to
patent holders.

5. Require all patient assistance programs in South Africa to provide
information on the criteria for assistance, the number of requests and the
number persons receiving the assistance.

6. For drugs or vaccines where there is a public interest in ensuring
adequate access, the Ministry of Health should be allowed to require the
manufacturer to disclose the units sold in the RSA.

On the topic of delinkage, South Africa should consider working with key
partners to encourage the World Health Organization, UNITAID or another
body to undertake a study of the feasibility of delinking prices for cancer
from R&D costs, and proposal that was debated during the 2017 World Health
Assembly in the resolution on cancer.

We welcome the opportunity to engage in further dialogue with your
government as you continue to work on these issues.

Sincerely and Respectfully submitted,

Manon Anne Ress, PhD, Acting Director and co-founder, UACT

Catherine Tomlinson, Member, UACT Board of Directors

Kirsten Myhr, MScPharm, MPH, Member, UACT Board of Directors

James Love, Member, UACT Board of Directors

Ellen F. M. ‘t Hoen, LLM, Chair, UACT Expert Advisory Committee

Gilberto de Lima Lopes Junior, MD, MBA, FAMS, Member, UACT Expert Advisory
Board

Ruth Lopert, MD, MMedSc,  FAFPHM, Member, UACT Expert Advisory Board

Ophira Ginsburg, MD, Member, UACT Expert Advisory Board

Leena Menghaney, Member, UACT Expert Advisory Board

Ilze Aizsilniece, Member, UACT Organizing Committee

Salomé Meyer (Independent Cancer Advocate)

The following Health NGOs working on cancer in South Africa

Amabele Belles’ Project Flamingo (link)
Breast Health Foundation (BHF) (link)
The Cancer Association of South Africa (CANSA) (link)
Childhood Cancer Foundation South Africa (CHOC) (link)
Can-Sir (link)
CanSurvive (link)
Care for Cancer Foundation (link)
Hospice Palliative Care Association (HPCA) (link)
IGAZI Foundation (link)
Look Good Feel Better (link)
Lymphoedema Association of South Africa (LAOSA) (link)
Movember/The Men’s Foundation (link)
NONSA
Pancreatic Cancer Action Network South Africa (PanCAN) (link)
Pocket Cancer Support (link)
People Living with Cancer (PLWC) (link)
Pink Trees for Pauline (link)
Rainbows and Smiles (link)
Reach for Recovery (link)
The Sunflower Fund (link)
Vrede Foundation (link)
Wings for Hope (link)

Cc:

Dr Aaron Motsoaledi, Minister of Health
Naledi Pandor, Minister of Science and Technology
Malebona Precious Matsoso, Director-General, Department of Health
Marumo Nkomo, Director: Legal – International Trade & Investment,
Department of Trade and Industry
Interministerial Committee, via  ippolicy2017 at thedti.gov.zahttps://
cancerunion.org/2017/10/10/uact-and-22-cancer-treatment-ngos-submit-comments-on-south-africa-ip-policy/

On October 10, 2017, UACT and 22 NGOs working on cancer in South Africa,
submitted comments to the South Africa on the Draft South Africa IP Policy.

The text of the submission follows:

October 10, 2017

The Honorable Dr. Rob Davies Minister of Trade and Industry
77 Meintjies Street Sunnyside,
Pretoria, Gauteng, South Africa

Re: Draft National Policy on Intellectual Property

Dear Minister Davies,

We write to you on behalf of the Union for Affordable Cancer Treatment
(UACT), a union of people affected by cancer, their family members and
friends, people who take care of people with cancer, health care
professionals and cancer researchers committed to increasing access to
effective cancer treatment and care. UACT is particularly concerned about
the rapidly escalating cost of cancer medication and seeks to fight for
cancer treatment and care to be affordable and available, everywhere, for
everyone who needs it.

UACT wishes to offer some brief comments on the Draft Intellectual Property
Policy of the Republic of South Africa, Phase I 2017, specifically with
regard to IP and health. We appreciate that the draft takes positive steps
but would like to see South Africa go further in implementing policies that
make “access to medicines for all” a reality.

There are many proposals in the policy that we were pleased to see,
including:

* Recommendations on the introduction of a substantive search and
examination (SSE) approach; improved patent opposition mechanisms; and the
adoption of patentability criteria “that address the country’s public
health and environmental concerns, as well as industrial policy objectives.”

* Positive language on the important role of voluntary licensing, with
particular emphasis on the transparency of terms and conditions in such
licenses as exemplified by the Medicines Patent Pool.

* Recommendations on the use of compulsory licensing reflecting steps
needed to make the process more streamlined and less encumbered by a
litigation process; government use licenses as a viable legal tool relevant
to the state’s obligation “to take reasonable legislative and other
measures to progressively realize the right to have access to health care
services…[including] the utilization of TRIPS flexibilities such as Article
31 (b), in full accordance with South African law;” and engaging with WTO
to streamline the cumbersome Paragraph 6 mechanism on compulsory licensing
for export.

* Recognition of the importance of multilateral cooperation, particularly
noting the work at the WHO on addressing “issues such as lack of
affordability, limited research where market returns are small or uncertain
. . “   and noting delinkage as among the core principles of the WHO
Consultative Expert Working Group.

UACT notes the use of TRIPS flexibilities and the principle of delinkage
were recommended as key strategies to improve policy coherence in the UN’s
2030 Agenda for Sustainable Development and in the 2016 Report of the UN
High Level Panel on Access to Medicines.

UACT is concerned that South Africa has not acted to induce non-voluntary
licensing of drug patents since 2003 in the Hazel Tau case, and that case
involved the independent RSA Competition Commission, rather than an
executive agency.

While we applaud and support the idea of streamlining the process, we also
suggest the grounds for licensing should include some that are mandatory,
so the compulsory licensing process is self executing when a need is
presented.  One benefit of a mandatory compulsory licensing ground is that
the RSA government officials could not be pressured or lobbied to withhold
a license, since the policy to issue the compulsory license was automatic
if the grounds themselves are satisfied.  An example of a mandatory
non-voluntary authorization is the U.S. U.S. Biologics Price Competition
and Innovation Act of 2009, which eliminates the possibility of an
injunction for infringement when the patent holder fails to provide timely
constructive disclosure of the patent landscape on biologic drugs, or
Section 92A of India’s patent law, which provides that

“Compulsory licence shall be available for manufacture and export of
patented pharmaceutical products to any country having insufficient or no
manufacturing capacity in the pharmaceutical sector for the concerned
product to address public health problems. . . ”  [emphasis added].

Here we suggest one of two approaches for consideration.  The first is a
non-voluntary authorization to use an invention in the context of Article
31 of the WTO TRIPS agreement:

Option 1, as an exception to the exclusive right

Non-voluntary use of patented invention in the field of use of a drug,
vaccine or other medical technology shall be allowed, subject to the
payment of a reasonable and affordable royalty, whenever a drug or vaccine
is not available at a price that is reasonable and/or affordable for the
general population or any significant group of potential patients, and
there is evidence that access is limited due to the price.  A decision that
the price for a product is not generally reasonable and/or affordable can
be made either by the Ministry of Health, the premiers of any provinces,
the South Africa Competition Commission, or by any judge in a lower court.


The second approach is similar, except that it is framed as a limitation on
remedies, under Article 44.2 of the TRIPS.  The advantage of the second
approach is that avoids the restrictions in the WTO relating to Article 31
of the TRIPS, such as a requirement for prior negotiation on reasonable
commercial terms and condition, and it does not limit exports.  The
limitation on remedies is the approach taken in the U.S government use
statute (35 USC 1498) and the U.S. Biologics Price Competition and
Innovation Act of 2009 and the dozens of compulsory license that have been
issued in the United States by the courts in the context of the enforcement
of infringements.

Option 2, as a limitation on the remedies for infringement

The remedies for infringement of a patent on an invention in the field of
use of a drug, vaccine or other medical technology shall be be limited to
the payment of a reasonable and affordable royalty, whenever a drug or
vaccine is not available at a price that is reasonable and/or affordable
for the general population or any significant group of potential patients,
and there is evidence that access is limited due to the price.  A decision
that the price for a product is not generally reasonable and/or affordable
can be made either by the Ministry of Health, the premiers of any
provinces, the South Africa Competition Commission, or by any judge in a
lower court.


We believe option 2 is best, although either approach would be a vast
improvement on the current law.

In addition, as part of the streamlining of the procedures, UACT recommends
South Africa adopt royalty guidelines for non-voluntary licenses,
considering, for example, the 2005 WHO and UNDP royalty guidelines as a
model.

One of the topics not discussed in the Draft Policy concerns transparency,
particularly as it relates to the management of intellectual property
rights and the economic factors that are relevant to the pricing of
medicines, vaccines and other medical technologies.

As one country, the RSA has limits on the leverage it can exercise to
ensure transparency, but there are measures it can take, and the government
can also work with others in fora such as the World Health Organization to
promote standards on transparency.

At a national level, the RSA could require the following transparency
measures,  all of which are designed to public and to benefit and inform
the general public.

1. An annual reporting of  yearly and cumulative sales earned by every drug
or vaccine registered for sale in the RSA market that does not face
competition from a generic product.

2. For each new drug registered in the RSA, the amount of money spent on
each clinical trial used to justify the registration of the drug, and all
public subsidies including tax credits that were relevant to each trial.

3. The patent asserted for every drug or vaccine, including an explanation
of how each patent is relevant to the drug, making a failure to disclose
sanctioned by an elimination of damages or inductions, as in the U.S.
Biologics Price Competition and Innovation Act of 2009.

4. Require transparency of all royalty patents on patents granted in RSA to
patent holders.

5. Require all patient assistance programs in South Africa to provide
information on the criteria for assistance, the number of requests and the
number persons receiving the assistance.

6. For drugs or vaccines where there is a public interest in ensuring
adequate access, the Ministry of Health should be allowed to require the
manufacturer to disclose the units sold in the RSA.

On the topic of delinkage, South Africa should consider working with key
partners to encourage the World Health Organization, UNITAID or another
body to undertake a study of the feasibility of delinking prices for cancer
from R&D costs, and proposal that was debated during the 2017 World Health
Assembly in the resolution on cancer.

We welcome the opportunity to engage in further dialogue with your
government as you continue to work on these issues.

Sincerely and Respectfully submitted,

Manon Anne Ress, PhD, Acting Director and co-founder, UACT

Catherine Tomlinson, Member, UACT Board of Directors

Kirsten Myhr, MScPharm, MPH, Member, UACT Board of Directors

James Love, Member, UACT Board of Directors

Ellen F. M. ‘t Hoen, LLM, Chair, UACT Expert Advisory Committee

Gilberto de Lima Lopes Junior, MD, MBA, FAMS, Member, UACT Expert Advisory
Board

Ruth Lopert, MD, MMedSc,  FAFPHM, Member, UACT Expert Advisory Board

Ophira Ginsburg, MD, Member, UACT Expert Advisory Board

Leena Menghaney, Member, UACT Expert Advisory Board

Ilze Aizsilniece, Member, UACT Organizing Committee

Salomé Meyer (Independent Cancer Advocate)

The following Health NGOs working on cancer in South Africa

Amabele Belles’ Project Flamingo (link)
Breast Health Foundation (BHF) (link)
The Cancer Association of South Africa (CANSA) (link)
Childhood Cancer Foundation South Africa (CHOC) (link)
Can-Sir (link)
CanSurvive (link)
Care for Cancer Foundation (link)
Hospice Palliative Care Association (HPCA) (link)
IGAZI Foundation (link)
Look Good Feel Better (link)
Lymphoedema Association of South Africa (LAOSA) (link)
Movember/The Men’s Foundation (link)
NONSA
Pancreatic Cancer Action Network South Africa (PanCAN) (link)
Pocket Cancer Support (link)
People Living with Cancer (PLWC) (link)
Pink Trees for Pauline (link)
Rainbows and Smiles (link)
Reach for Recovery (link)
The Sunflower Fund (link)
Vrede Foundation (link)
Wings for Hope (link)

Cc:

Dr Aaron Motsoaledi, Minister of Health
Naledi Pandor, Minister of Science and Technology
Malebona Precious Matsoso, Director-General, Department of Health
Marumo Nkomo, Director: Legal – International Trade & Investment,
Department of Trade and Industry
Interministerial Committee, via  ippolicy2017 at thedti.gov.za

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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