Access:
the problem
More than one-third of the world’s population lacks
regular access to essential medicines[i], many people need to pay out-of-pocket
for medicines they can access, regulatory authorities often face incredible
difficulties in carrying out their mandate and financing for health
is still very limited: in some countries, it is less than US $2 per
person per year. In spite of ad hoc donation programmes, promises
of differential prices, international accords and so-called public-private-initiatives,
the poorest nations continue to suffer from lack of access to medicines.
A key moment for WHO & Access
Recently, a number of developments have changed the
global setting for access to medicines. These can be turned into concrete
steps by WHO:
· WHO is participating in the collection of price information data and
developing a methodology to collect and analyse price information.
· The prequalification process for HIV/AIDS-related medications has
yielded initial results.
· Because of the Doha Agreement, WHO can play a significant role in
the implementation and interpretation of pro-public health intellectual
property laws.
· WHO’s model list of essential medicines has been revised to become
more independent, transparent and evidence-based.
Specifically,
WHO should support the following means to improve access to medicines:
Equitable
prices
People in every country have a right to affordable medicines.
Governments have an obligation to enact laws, regulations and policies
that ensure access to affordable essential medicines for all of their
citizens, and in particular the poor. They can use various mechanisms
to achieve equitable prices, including promoting
generic competition, enacting
and implementing pro-public health national trade legislation as allowed
by TRIPS, and implementing differential pricing policies.
Generic competition
Pricing studies have shown unequivocally that generic
competition is the most effective way to ensure lasting price reductions.
In Brazil, where generic competition for antiretrovirals was introduced
in 1997, there has been a constant trend of decreasing prices as generics
are introduced.[ii]
Globally, this trend is illustrated with a "typical" three-drug
cocktail of zidovudine, lamivudine and nevirapine. Before an Indian
generic pharmaceutical company announced its price reductions, this
combination of medicines cost up to US$10,000 per patient per year.
Shortly after the announced price reduction, multinational pharmaceutical
companies lowered their prices. When other generic companies announced
even lower prices, the multinational companies responded by lowering
their prices even more. As in all market situations, the introduction
of competition drives prices down in a sustainable manner that is
free from extraneous conditions.
Pricing
studies: The WHO has begun several
projects related to drug pricing. This work should be supported and
broadened. Price lists should be updated on a regular basis.
Prequalification
process: NGOs congratulate the WHO on its work with the prequalification of
drugs for HIV/AIDS. This work needs to be supported and expanded to
include medicines for diseases such as malaria and tuberculosis. Member
states need to recognise the significance of the prequalification
process and take advantage of the results of the work undertaken by
WHO. National drug regulatory programmes should recognise the prequalification
of medicines under WHO's programme.
Post Doha: TRIPS & public health
The only way to pave the way for generic competition
is for countries to fully utilise the provisions in TRIPS that allow
them to put citizens before corporate patent privileges. In November
last year, 142 countries affirmed the priority of public health over
private intellectual property at the 4th WTO Ministerial
Conference in Doha, Qatar.
Key excerpts from the Doha Declaration[iii]
·
"We agree that the TRIPS Agreement does not and
should not prevent members from taking measures to protect public
health."
·
“…the Agreement can and should be interpreted and implemented
in a manner supportive of WTO members' right to protect public health
and, in particular, to promote access to medicines for all.”
·
“We recognise that WTO members with insufficient or no
manufacturing capacities in the pharmaceutical sector could face
difficulties in making effective use of compulsory licensing under
the TRIPS Agreement. We instruct the Council for TRIPS to find an
expeditious solution to this problem and to report to the General
Council before the end of 2002.”
NGOs commend the Executive Board on its recommendation
that WHO needs to take a proactive role in the implementation of the
Doha Declaration.
TRIPS: the question of exports of medicines.
Paragraph 6 of the Doha Declaration on TRIPS promised that the WTO
would find a solution to the problems countries face when trying to
obtain low cost generic medicines, and domestic production is not
efficient. There are technical problems with the exact language
in paragraph 6 of the Doha Declaration, which reflect some of the
confusion regarding the nature of problem. But now there is a better
understanding of these issues, and a growing consensus among public
health experts over the appropriate solution. Developing countries
and NGOs have asked the WTO to clearly recognise the right of countries
to authorise the export of health care products, without the consent
of the patent owner, so long as the legitimate rights of the patent
owners (if any) are protected in the country where the products are
ultimately used by patients. To clarify, NGOs accept the notion
that patent owners will be compensated in the country of consumption,
under WTO TRIPS rules, but want assurances that patients can obtain
the most efficient global suppliers. This debate is about how the
WTO will interpret Article 30 of the TRIPS, the provision now used
to allow countries to waive patent rights for experimental purposes,
personal use, compassionate use, or for
pre-approval testing (the Bolar exception). NGOs and developing
countries are asking that Article 30 be used for exports of medicines
and other health care products, for example, if the importing country
can certify that such use is needed for domestic public health purposes.
The WHO has been on the sidelines on this important debate, and should
support further the notion that Article 30 of the TRIPS be used to
allow such exports, for example, by providing the WTO with a well
reasoned rationale for allowing Article 30 to be used for exports.
Differential pricing
Differential pricing has been going on for years. Many
studies have shown that, in some cases, people in developing countries
pay more for medicines
than people in more developed countries. In the United States, Pfizer’s
fluconazole costs US$12.20 per tablet but in Guatemala, it costs up
to US$27.60 per tablet.[iv] Two years
ago, the multinational pharmaceutical companies resisted differentiating
their markets in favour of poorer countries. Now, because of recent
actions by some countries to challenge patents, pharmaceutical companies
are looking at differential pricing as the solution to the pricing
problem. However, this is not necessarily the best solution. Differential
pricing programmes often come with conditions attached.
Reported industry-imposed conditions on
differential pricing agreements
·
extra processing fees
·
limited geographic distribution
·
limited provider distribution
·
disclosure of consumer information to companies
·
unacceptable delivery terms and/or product dating
For
differential pricing to work, citizens and governments need to be
able to buy the needed medicines without unfair conditions.
Differential pricing can be part of the solution only
if people, governments or donors are in a position to bargain competently
and under fair conditions with companies over price. Companies should
not be allowed to set conditions or limit the time frame for the price
reductions on essential medicines. No company should be able to insist
that people, governments or donors forego normal rights, such as medical
record confidentiality or the ability to legislate and regulate for
public health in order to achieve reduced prices. Furthermore, differential
pricing needs to be part of a systematic solution and not based on
ad hoc responses from industry.
WHO at country
level
WHO must engage more extensively at country level to
assist governments in adopting pro-health strategies related to access
to medicines, including assisting with intellectual property law revisions
and negotiations with pharmaceutical companies. This would complement
WHO’s strategy to increase staffing and expertise at country level.
WHO must also continue to work closely with civil society and the
NGOs welcome the stated commitment to do so in Resolution EB109.R17.
Model
essential medicines list
The 12th model list on essential medicines
(EML, previously known as EDL) is an important step forward. The Essential
Medicines Committee added 10 antiretrovirals to the core essential
medicines list and highlighted the importance of fixed-dose combinations
(FDCs) of certain antiretrovirals. As competing research-based pharmaceutical
companies are unlikely to make FDCs, this is a unique opportunity
for generic drug companies to assist in the war against AIDS.
The new process for adding or deleting medicines to/from
the list is more transparent, uses evidence-based systematic reviews,
and is faster. WHO should continue this important work, in spite of
the efforts of some member states to dilute the process. It is encouraging
that cost will no longer be a barrier to inclusion on the list. However,
the expansion of the EML must be linked with measures to ensure that
medicines are affordable to those who need them.
The value of the EML lies in its political signal and
how effectively it can be adapted and implemented at country level.
WHO should strengthen its country support and advise local experts
how to implement the essential medicines concept. At every level,
the use of the EML must be linked to efforts to make essential medicines
more affordable and available.
Public-private
initiatives (PPIs)
NGOs are concerned about the lack of progress on WHO’s
commitments related to the revision of guidelines meant to steer its
interactions with the commercial sector. The document EB 107/20 indicates
that Executive Board members at a retreat last November put forward
a number of suggestions to focus WHO work in this area. The revised
guidelines that EB members clearly called for are still not available.
PPIs have direct consequences for access. Consumers, governments and
donors are being asked to negotiate with pharmaceutical companies
on conditions of differential pricing schemes and donations. Furthermore,
it is not clear whether or not the desired public health outcomes
of large-scale initiatives to improve access, including GAVI, the
Global Fund and others, are at risk because of unaccountable private-sector
involvement. It is unclear on what basis WHO decides that a given
PPI is the best way to increase access to medicines.
WHO must take measures to identify the risks and benefits
of PPIs and should analyse, in a transparent manner, the health and
social outcomes and sustainability of these initiatives. WHO is and
must remain the centre of technical expertise and the global agency
for the protection and promotion of public health. WHO must ensure
that no relationship with industry compromises its technical responsibilities
or its credibility.
Recommendations for Action For
WHO:
Equitable
prices
·
WHO must continue and speed up its work in prequalifying
manufacturers of pharmaceuticals and raw materials for HIV/AIDS drugs.
The list must be extended to include drugs for other major killer
diseases such as malaria, tuberculosis and other infectious diseases.
Databases
·
WHO must continue to develop databases on essential drug
prices linking these with information from the prequalification process
and the World Intellectual Property Organization (WIPO) for patent
status information.
·
WHO should continue to play an active role as an official
observer at the WTO and continue its interactions with WIPO
·
WHO should continue to assist member states to develop
and formulate pro-health laws and regulations, including providing
models for compulsory licensing, parallel importing, generic manufacture
and other TRIPS-compliant measures that will help overcome current
barriers to accessing essential medicines.
·
WHO should continue its work with the Network for Monitoring
the Impact of Globalisation and TRIPS on Access to Medicines.
Essential
medicines list process
·
WHO should provide assistance to member states in creating
and implementing treatment guidelines and formularies using the new
EML.
Public-private
initiatives (PPIs)
·
WHO should publicly issue its revised guidelines and
related tools on PPIs (as called for by the EB more than one year
ago) to member states and for public comment. WHO should create an
independent expert group to conduct a comprehensive analysis of the
benefits and risks of PPIs, identify positive and negative PPI characteristics
and evaluate their impact on public health systems and WHO’s independence
and integrity. The group should then make recommendations to WHO based
on their findings. The expert group should have equitable representation
from the global South and public interest groups and the process should
be made completely transparent.
Collaboration
with civil society
·
WHO should continue its commitment to work closely with
NGOs.
Recommendations
for Action For Member States:
·
Member states should adapt their national EML to reflect
changes in WHO’s new list. Measures must be taken at country level
to ensure that medicines on the list are used according to rational
drug use policies. Furthermore, essential medicines at country level
must be made affordable and accessible to all citizens.
Public-private
initiatives
·
Member states should take a leading role in overseeing
PPIs, especially concerning essential medicines, to ensure that the
relationship and negotiations protect citizens, are without undue
conditions imposed by industry and lead to systematic solutions to
increase access to medicines.
Collaboration
with civil society
·
Governments should implement national drug policies based
on the essential drugs concept that are formulated and implemented
with the substantive involvement of citizens and NGOs.
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Essential
Medicines: WHO Definition
Essential drugs are those drugs that satisfy the
health care needs of the majority of the population;
they should therefore be available at all times in adequate
amounts and in the appropriate dosage forms, and at
a price that individuals and the community can afford.
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