E-DRUG: HAI Revised Drug Strategy Watch

E-drug: HAI Revised Drug Strategy Watch
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This is a year of major changes at the WHO, and a key question for
Health Action International (HAI)* is what these changes might mean
and should mean concerning WHO's revised drug strategy (RDS) and the
future and role of the Action Programme on Essential Drugs (DAP). One
of HAI's main activities has always been to advocate for a strong and
effective RDS, which is the World Health Assembly document that guides
WHO policies on drugs. To implement the RDS, DAP has been an
important force in promoting essential drugs concepts, rational drug
use and advising countries on national drug polices. HAI has been a
strong supporter of and counterpart to DAP in the promotion of
essential drugs and rational drug use, especially in the global South.

HAI believes there is reason to be concerned about the future
direction of WHO policies on drugs and about the future role of DAP
that require monitoring and advocacy within the NGO community and
among individuals working on health and medicines. The following are
some examples of trends this year that bear out this concern:

--In May at the World Health Assembly, countries sympathetic to the
high-profit, free-trade wishes of transnational pharmaceutical
companies, such as the United States and other powerful governments in
the global North, engineered the defeat of the resolution on the RDS,
which contained a clear position that public health interests should
be paramount in pharmaceutical and health policies. The resolution
also contained many other objectives and mandates concerning rational
drug use, drug promotion and other key issues of access to medicines
that became hostage to the disagreements over the language on trade
issues.

�In response to the disagreements over the resolution, the assembly
voted to send the resolution back to the WHO Executive Board (EB).
WHO subsequently announced a two-tiered approach to working on the
resolution: (1) the EB will establish an ad hoc working group on the
RDS that is open to all member states that will meet in Geneva that
will discuss and present a draft resolution to the EB for
consideration and (2) the EB will establish a subgroup comprised of
the chairman of drafting group established at the assembly and two
member states from each region, of which at least one must be a member
of the EB. According to the decision, "This group will assist the WHO
in its contacts with relevant interested partners."

It appears that the real negotiations on the RDS will take place in
this subgroup. It is also where the EB has ensured that the member
states, many in the global South, that called for the stronger
commitments to public health in trade issues, for example, will be
effectively neutralised by the tight requirements of the subgroup
membership. It is important to note that NGOs will not likely be
considered "interested partners" because they have never had any
formal rights or processes for inputs into drafting committees.

--In July, Brundtland appointed Dr. Michael Scholtz, a former
executive in marketing at a transnational pharmaceutical company to
head up the new management cluster for Health Technology and Drugs.
This means he will be in charge of DAP and be responsible for the
implementation of the RDS. It remains to be seen if Dr. Scholtz has
the necessary commitment to meeting the needs of poorer countries and
the hundreds of millions of people worldwide who do not have access to
essential and affordable drugs.

�In her speech to the assembly, Dr. Brundtland promised to create "a
WHO-industry roundtable" to have a "dialogue on key issues facing us."
WHO has announced that the first meeting of this roundtable will be
in October.

Revised Drug Strategy Watch

HAI agrees with other commentators who have pointed out the need to
monitor WHO closely. In particular HAI will focus on the cluster on
Health Technology and Drugs. HAI believes that an integrated strategy
will be needed to address the concerns outlined above:

�Activities concerning the EB process to redraft the RDS. The first
opportunity for NGO inputs should be at the regional committee
meetings that will be scheduled to discuss the RDS and to name members
to the EB subgroup (Europe region: 14-18 September in Copenhagen;
other regions have not yet posted meeting dates on the WHO website).
HAI encourages people and NGOs to make interventions with their
respective government representatives and to make direct inputs into
the process to the maximum extent possible. HAI will be providing
information and analysis to HAI members via HAI News and special
mailings and to other interested NGOs and individuals via electronic
mail lists and website postings.

�WHO-NGO interactions. At the assembly, Dr. Brundtland also stated
that she will "convene a conference with the NGO community to draw up
new guidelines for our cooperation to establish new mechanisms for
interaction with civil society in member states." HAI understands
that WHO is planning to announce a consultation with NGOs, possibly in
November. This meeting will be a crucial test for NGOs to prove that
they are prepared to meet Dr. Brundtland's call for more productive
interactions with civil society. Currently, WHO-NGO information
sharing and participation in policy and program is worked out by
individual programs and organisational units. There is no overall WHO
policy on NGO relationships.

HAI proposes that the NGO community should work for an overall policy
that is inclusive, substantive and that recognises the need for and
value of having a diverse representation of NGOs in WHO-NGO dialogues.
Specifically, HAI proposes the following: (1) NGOs should have formal
processes for making inputs into drafting processes; (2) WHO should
ensure that NGOs in the global South have direct and adequate
representation; (3) NGOs should be recognised by WHO automatically if
an NGO is recognised by the member state in which it is legally
established; (4) WHO-NGO mechanisms need to recognise and support the
flexible, independent and distinct characteristics of the NGO sector
and not invoke mechanisms that seek to create one NGO consensus
position or voice on international health matters; and (5) WHO
consultation mechanisms must recognise that pharmaceutical companies
enjoy and disproportionate advantage in access to WHO and have
extremely disproportionate resources available to influence WHO in
comparison to NGOs, and that mechanisms must seek to redress that
imbalance in substantive ways.

�The future of DAP. HAI understands that the mandate for the new
Heath Technology and Drugs cluster is currently under review. HAI
notes the substantive and positive contributions DAP has made to many
member states, especially in the global South, over the past years and
that HAI feels that it is important to monitor management decisions
concerning DAP and work to ensure that its policy and country program
work is not weakened or restricted in any way.

�Developing monitoring criteria. Mark Raijmakers suggested in an
E-Drug posting that the "contents and acceptance of the revised drug
strategy for the next WHA in May 1999 are criteria [for judging] the
management by Scholtz. The criterion should be that Scholtz will have
to find a balance between industry's and consumers' interests and
concerns in the new revised drug strategy to be proposed." HAI
supports this suggestion, which can be further developed in the
coming months.

�Ongoing monitoring criteria. HAI has ongoing monitoring, for example
of WHO policy and program commitments to promote the marketing of
effective, necessary and affordable medicines in all countries, of
commitments to guidelines and advice concerning the ethical promotion
of drugs, which WHO should strengthen and expand, and of DAP's ability
to address health and trade issues, which should be supported and
expanded.

Additional criteria for monitoring the RDS and the future of DAP.
These can and should be developed, especially ones that promote the
sharing of information from local and national levels. HAI would
welcome dialogue about developing additional criteria that could be
finalised at the November WHO-NGO meeting.

HAI welcomes comments and suggestions about the RDS Watch and looks
forward to being able to work with interested individuals and NGOs to
ensure its success.

For further information, please contact:

Health Action International Europe (HAI-Europe)
Jacob van Lennepkade 334 T, 1053 NJ Amsterdam, Netherlands
tel: +31 20 6833684, fax: +31 20 6855002
email: hai@hai.antenna.nl

*For readers not familiar with HAI, it is an informal network of some
150 consumer, health, and other public interest groups involved in
health and pharmaceutical issues in 70 countries around the world.
HAI actively promotes a more rational use of drugs. It believes that
all drugs marketed should meet real medicinal needs, have therapeutic
advantages, be acceptably safe, and offer value for money. HAI has
regional offices located in Amsterdam (HAI-Europe), Lima (HAI-Latin
America), Penang (HAI-Asia and Pacific) and it will be establishing a
regional office for HAI Africa in 1999.

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