[Ip-health] Fwd: TWN IP Info: South to introduce resolution on access to medicines

Gopa Kumar kumargopakm at gmail.com
Thu Jun 6 22:16:39 PDT 2013

*Title :* TWN IP Info: South to introduce resolution on access to medicines
*Date :* 07 June 2013


TWN Info Service on Intellectual Property Issues (Jun13/02)
7 June 2013
Third World Network

*South to introduce resolution on access to medicines
Published in SUNS #7599 dated  6 June 2013*

New Delhi, 5 Jun (K. M. Gopakumar) -- Developing countries are set to
introduce a resolution on access to medicines at the current session of the
United Nations Human Rights Council.

The 23rd regular session of the Human Rights Council is taking place from
27 May to 14 June in Geneva and the draft resolution is expected to come up
for consideration next week.

Brazil, in its intervention on the "Report of the Special Rapporteur on the
right of everyone to the enjoyment of the highest attainable standard of
physical and mental health, Anand Grover, on access to medicines"
(A/HRC/23/42), stated that developing countries including India, Brazil,
South Africa, Egypt and Thailand will introduce the draft resolution at the
Council. It will take forward the recommendations of the Special Rapporteur.

It is learned that informal negotiations are already underway. The draft
resolution requests States, the UN and other intergovernmental
organisations to address the existing challenges with regard to access to
medicines in the context of the right to health, and the ways to overcome
those challenges.

The report of the Special Rapporteur on access to medicines, which was
introduced at the Council meeting on 27 May, "identifies and analyses
challenges and good practices with respect to access to medicines in the
context of the right-to-health framework".

It uses the key human rights framework on access to medicines, i. e.
availability, accessibility, acceptability and quality to analyse the
international and national determinants to access to medicines.

In the first section of the report, the Special Rapporteur reviews the
international legal framework as it applies to access to medicines. In the
second section, he identifies key determinants of access to medicines and
discusses challenges and good practices with respect to each aspect. The
key determinants identified in the report are: local production of
medicines, price regulations, medicines lists, procurement, distribution,
rational and appropriate use and quality of medicines.

The Special Rapporteur clearly states that, "access to affordable and
quality medicines and medical care in the event of sickness, as well as the
prevention, treatment and control of diseases, are central elements for the
enjoyment of the right to health". Further, he "calls upon States to shift
from the dominant market-oriented perspectives on access to medicines
towards a right-to-health paradigm in promoting access to medicines".

According to the report, there are four key measures to be carried out by a
State to fulfill its obligation with regard to access to medicines within
the right-to-health framework. These are: (i) availability of medicines in
sufficient quantities in public health facilities based on list of
essential medicines selected to meet the priority health needs of the
population; (ii) measures to ensure economic and physical access to the
medicines on a non-discriminatory basis; (iii) measures to ensure that
medicines that are determined are culturally and ethically acceptable to
the people; and (iv) a strong regulatory mechanism coupled with transparent
process to ensure quality, safety and efficacy of medicines.

The report urges States to adopt a national health policy with a national
plan of action to ensure access to medicines. Further, it encourages States
to ensure that national plans should adhere to the "central principles of
non-discrimination, transparency, accountability, and multi-stakeholder
participation, particularly of affected communities and vulnerable groups."

The findings and recommendations of the Special Rapporteur on the six
determinants of access to medicines contained in the report are as follows:


The report states that local production is "politically and strategically
important for developing countries to ensure the security of access to
medicines for their populations through local production".

It notes the global disparity in the consumption and production of
medicines. According to the report, during 2004-08, North America, Europe
and Japan accounted for 95 per cent of the medicines sales. It also reveals
that 90 per cent of the global production of medicines during the same
period was also concentrated in the developed countries.

Calling for a "coherent policy framework that explicitly links local
production to improved access to medicines", the report further suggests
the following policy options to countries to create an enabling environment
for the local production of pharmaceuticals: (i) levying taxes on imports
of medicines that could be locally produced, except for active
pharmaceutical ingredients which are generally not imported; (ii) providing
subsidies; (iii) tax incentives; (iv) guaranteed government procurement to
local manufacturers; and (v) a regulatory framework to increase local

It also highlights the indirect benefits of local production to: (i)
promote transfer of technology, (ii) provide employment and
capacity-building of local people through training programmes for local
pharmacists, microbiologists and technicians, and (iii) set up local
institutes of higher education and contributing to capacity-building of the
regulatory agencies. It further stresses the need for states to take
advantage of the flexibilities under the WTO Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS Agreement) and the 2001 Doha
Declaration on TRIPS and Public Health.

It makes the following policy measures with regard to long-term security
and affordability of medicines through local production: to develop a
policy framework on local production of medicines to ensure long-term
accessibility and affordability of medicines; to strengthen the regulatory
framework to increase the competitiveness of the local industry and provide
administrative and financial support, subsidies and guaranteed purchases;
to use flexibilities under the TRIPS Agreement to promote regional
collaboration to pool resources and facilitate competitiveness of local


The report states that "affordable and equitable pricing of essential
medicines is therefore a key determinant of access to medicines in most
developing countries." It notes that in developing countries, up to
two-thirds of expenditure on medicines are out-of-pocket payments. It also
finds that the catastrophic payment on medicines is pushing annually
"approximately 100 million people, mostly in developing countries, into
poverty." To address the price question, it discusses policy measures in
the following areas: price control, mark-ups, tariffs, taxes,
manufacturers' prices and competition law.

The report observes that in developed countries, governments frequently
apply price control mechanisms as part of their overall strategy to contain
costs primarily due to the substantial coverage of the population through
insurance. It notes that in the absence of price control in developing
countries with high-income inequality, only rich people can access the
medicines. Therefore, the report states: "States that inadequately use
price controls to ensure affordability of medicines would fail in their
obligation to use all available resources, including regulatory powers, to
promote the right to health."

On mark-ups on medicine prices, the report finds that mark-ups can account
for up to 40% of the price of the medicine. Hence, it stresses the need to
control the mark-ups in medicine price, and urges "States to assess the
impact of distribution mark-up regulations on medicine prices while
maintaining the viability of different actors in the supply chain to ensure
security of the medicines supply chain".

Further, the report advocates for the use of competition law and policy to
curb the abuse of dominant position in the market by the pharmaceutical
companies. These abuse include charging excessive prices, restricting other
companies from accessing the market, collusive tender practices, and
restrictive agreements. It remarks, "Competition law represents an
accountability mechanism for legal redress under the right-to-health
framework and provides a powerful tool to check wrongful practices by
pharmaceutical companies that engage in anti-competitive practices, which
can also negatively affect access to medicines."

Further, the report suggests the use of competition law to monitor the
mergers between generic and brand name pharmaceutical companies, which
could potentially block future market competition. It also states that a
well-formulated competition law can curb anti-competitive practices at
every stage of the pharmaceutical supply chain including restrictions for
the supply of active pharmaceutical ingredients.

The report recommends that States:

   - Adopt price control measures in pricing and reimbursement policies
   with a view to ensuring access of the population, and vulnerable groups
   particularly, to affordable medicines;
   - Select countries with a similar level of economic development to that
   of the State concerned as reference countries in order to secure the lowest
   price medicines through external reference pricing;
   - Monitor and regulate, if necessary, manufacturers' selling prices as
   well as distribution mark-ups in the supply chain, while ensuring
   incentives for wholesalers and retailers for sustainable distribution;
   - Resist trade policies that undermine the ability of States to
   reimburse the price of essential medicines to local pharmaceutical
   - Eliminate import tariffs on medicines, except when considered to be
   strategic to the promotion of local production of essential medicines;
   - Remove taxes on all medicines, especially essential medicines, and
   consider other revenue options for health, such as excise taxes on socially
   harmful goods such as tobacco, alcohol and junk foods;
   - Adopt competition laws and policies to prevent pharmaceutical
   companies from indulging in anti-competitive practices and promote
   competitive pricing of medicines together with strong enforcement;
   - Promote competitive policies across therapeutic markets to secure
   reductions in prices of medicines over tiered pricing to secure a greater
   government role in decision-making related to prices of medicines.


The report advocates for the preparation of a National List of Essential
Medicines (NEML) to address the health needs of the people as a first step
to ensure availability of essential medicines. It states that under the
right-to- health framework, "the process of selection of essential
medicines should be evidence-based, transparent and participatory".

However, it notes that often, States exclude civil society and community
representatives from the selection process of NEML. It further notes
deficiencies in the approaches of the WHO Essential Medicines List (EML)
process. First, it notes the reluctance to include patented medicines and
cites the specific example of the exclusion of patented antiretrovirals
(ARVs) like Raltegravir, Darunavir and Etravirine from EML.

It also points out that only 22 per cent of the 359 essential medicines on
the 2003 WHO EML relate to non-communicable diseases (NCDs) and notes
further that "several applications for the treatment of mental health,
cancers and cardiovascular diseases are pending review by the WHO Expert
Committee". It underscores "the under-representation of medicines for NCDs
in the WHO EML".

The report further notes that it is important to "ensure that the revisions
to the WHO EML are conducted in an inclusive and transparent manner that
addresses concerns of all groups".

It recommends that States: Adopt a national essential medicines list and
regularly update it by selecting essential medicines that are
evidence-based and adequately reflect the national burden of disease,
irrespective of cost or patent status, including through a transparent and
participatory determination process; ensure that access to essential
medicines for treating mental health, drug dependence, sexual and
reproductive health and palliative care is based purely on health needs and
evidence and not restricted on account of extraneous non-health
considerations; ensure that the list of National Essential Medicines is
arrived at with participation of all stakeholders, including the affected
communities, particularly the vulnerable groups.


The report clearly underlines the importance of an efficient and
transparent procurement of medicines to ensure the availability of
medicines in public health facilities. It stresses that an "efficient
procurement system is one that relies on transparent management, a limited
drug selection that is based on a restricted list (for example, NEML),
accurate and scientific forecasting of need, competitive tendering, bulk
purchasing, pre-qualification of proposed suppliers and close monitoring of
selected suppliers, and reliable financing."

It further stresses the need for taking measures to address medicine
stock-outs, observing that shortage of medicine stock forces patients to
resort to more expensive private health centres, inappropriate medicines or
even forego treatment altogether.

The report recommends the following measure to streamline the procurement
mechanism: "Adopt scientific and evidence-based quantification of essential
medicines, ensure competitive bidding, require stringent pre-qualification
for suppliers, monitor delivery of medicines and formulate effective
policies to address stock-outs".


The report states that "the right to health obliges States to ensure that
distribution systems function in a manner that secures physical
accessibility to quality essential medicines at all points of
distribution". Therefore, it advocates for the control of the quality of
the distribution chain to ensure that medicines should be transported and
stored at the required temperature and as per the labeling requirements.
The medicines should be stored in clean, dry and well-sanitised areas.

It therefore calls for urgent investment to develop adequate distribution
infrastructure for public health facilities. As an alternative, the report
proposes a provision in the procurement contract requiring the supplier to
deliver medicines directly to district-level stores or health facilities.
It recommends: "Increase financial, technical and logistical support to
strengthen distribution networks, maintain the quality of medicines in
transport and storage and adopt distributor certification programmes."


The report mentions that the State's obligation under the right to health
also extends to how medicines are prescribed, dispensed, sold and used. It
notes that errors in prescription, dispensation and use of medicines can
cause adverse health events and drug reactions. It states, "Incorrect
choice of medicines by physicians has been linked to higher levels of
resistance, increased costs, morbidity and mortality in patients". It
therefore advocates for the extensive use of Standard Treatment Guidelines
(STG) as a way forward to address the issue.

The report also points out that many stakeholders perceive the unethical
promotion of medicines as a serious concern. It observes: "Doctors are
offered gifts under the pretext of continued medical education.
Multinational pharmaceutical companies have been fined for promoting
unapproved medicines, with little impact on their practices. Unethical
promotion negatively affects the prescribing patterns of doctors, who would
then tend to prescribe less rationally and to quickly adopt new medicines.
Prescribers consequently obtain information on medicines from
pharmaceutical companies, rather than consulting STGs".

It recommends the "formulation of strong enforceable regulatory systems,
with accountability measures, to discourage unethical marketing and
promotion of medicines by pharmaceutical companies".

It further makes the following recommendations: Develop and regularly
update Standard Treatment Guidelines and ensure adequate training of
prescribers as a part of continuing medical education policies; regulate
pharmacies, including online pharmacies, and retailers to ensure
appropriate dispensation of medicines; prohibit unethical commercial
marketing and promotion of medicines by pharmaceutical companies through
legal accountability measures based on strict penalties and cancellation of
manufacturing licenses.


According to the Special Rapporteur's report, the right-to-health framework
obligates States to protect people from unsafe and poor-quality medicines.
This obligation includes the registration and marketing of good quality,
safe and efficacious products under ethically and medically validated
clinical trials, continuous regulation of the quality of production of
medicines and prevention of sub-standard and spurious medicines from being
sold on the market after registration.

It clearly articulates the issue of access to data especially related to
the quality, safety and efficacy of medicines that is necessary for the
enjoyment of the right to health. Further, the report notes that in "the
Special Rapporteur's consultations, diverse stakeholders noted
non-transparency of clinical trial data as a concern".

Therefore, the Special Rapporteur "encourages States to take regulatory
measures to ensure that information on the safety, quality and efficacy of
medicines, even if negative, is made publicly available in functional trial

The report also finds that "contrary to popular belief, recent studies
indicate that there may be fewer poor quality medicines on the market than
previously estimated. A potential explanation for this could be the
tendency to conflate poor-quality with counterfeit medicines".

The report rejects the conflation of intellectual property issues with
quality, safety and efficacy of medicines. It clearly states: "The Special
Rapporteur also notes the ongoing global debate to deal with the growing
challenge of counterfeit medicines. He points out that since the term
‘spurious/sub-standard/falsely-labelled/falsified and counterfeit' (SSFFC)
medicines was coined, it has regrettably been used as a catch-all phrase to
represent anything from poor quality to ‘counterfeit' medicines, which is
specific to the domain of trademark violations. Such a linkage is
counterproductive to access to medicines. This type of conflation was
demonstrated by incidents in which unilateral action was taken by some
countries against legitimate generic medicines as being counterfeit and
even under the national laws in some countries, which included generic
medicines under the definition of counterfeit medicines, thereby
threatening (generics) import into that country. The Special Rapporteur
expresses concern that an international legal remedy focusing on
enforcement of trademark rights to counter the problem of counterfeit
medicines takes away from the public health focus of strengthening of
regulatory capacities in developing countries to deal with poor quality
medicines and instead diverts limited State policing machinery to enforce
private rights".

The report recommends that States: Ensure transparency of data related to
quality, safety and efficacy of medicines, including the mandatory
publication of adverse data; increase budgetary support for national
regulators and increase recruitment of inspectors at competitive salaries;
improve South-South cooperation to conduct joint inspections of
manufacturing facilities and share information and good practices; and
avoid conflation of poor-quality medicines, a quality control issue, with
counterfeit medicines, a trade issue. +

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