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:
LOCAL PRODUCTION
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 competitiveness.
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 production.
PRICING
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 companies;
- 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.
MEDICINES
LISTS
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.
PROCUREMENT
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".
DISTRIBUTION
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."
RATIONAL AND APPROPRIATE USE
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.
QUALITY
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 registries".
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.
