5-6 June 1998 London, UK
|
International
Seminar on Access to Treatment for HIV in Developing Countries
5-6 June 1998 London, UK |
Dr Joseph Saba, Clinical Research
Specialist
Department of Policy, Strategy, & Research, UNAIDS
Geneva, Switzerland
Status Report on the four Pilot countries
1. Uganda
2. Cote d'Ivoire
3. Vietnam
4. Chile
Pharmaceutical Company Involvement
Background
Intensive discussions on the Drug Access Initiative took place from
November 1996 to June 1997 with representatives of the major pharmaceutical
companies, government officials in developing countries, public health
experts, NGOs and persons living with HIV. It was during this time that
the background document for this initiative was formulated.
Meetings with participants and stakeholders
In June 1997 a three-day meeting was held in Geneva. The first day
was for discussions with various pharmaceutical companies, the second for
discussions between the countries and the pharmaceutical companies, and
the third day for discussions with country representatives on country specific
issues.
The meeting with the executives of the pharmaceutical companies took place on 16 June 1997. The discussion focused on concerns with regard to feasibility and implications of the initiative, and on determining strategies to proceed with the establishment of the pilot phase. The main concern of the pharmaceutical companies was ensuring the sustainability of this process, which will require strong political commitment by the countries.
The companies regarded the protection of intellectual property rights as a critical issue, and this was discussed at length. The outcome of the discussions was twofold:
A meeting of country representatives, Ministers of Health, persons living with HIV/AIDS, pharmaceutical companies and UNAIDS co-sponsors took place on 17 June 1997. In this meeting, the pilot country governments were made aware of the interest of the pharmaceutical companies in the initiative, and in turn made the pharmaceutical companies aware of the commitment of the governments to participate in and implement the initiative. The role of the advisory board was discussed at length and found to be acceptable, although a variety of details remained to be discussed at the country level.
It was agreed that price subsidy negotiations would be discussed further at the country level as the implementation process continues. It was also stressed that although cost is clearly an obstacle to access to drugs, there is also a great need to strengthen the health care infrastructure to allow for proper usage of drugs. It was suggested that the distribution systems should be adapted whenever possible to avoid creating parallel systems.
On 18 June 1997, the country representatives, co-sponsors and NGOs met
and discussed critical issues, such as the Non Profit Company and procurement
and distribution systems, which could affect the implementation of the
initiative.
Announcement of Initiative The initiative was publicly announced in
November 1997 during a press conference. The accompanying press release
emphasised the interest on the part of the pharmaceutical companies to
make drugs more affordable and the role of national governments to improve
health system infrastructures. At that time, only three companies had confirmed
their participation in the initiative with others companies reviewing their
possible involvement.
Ongoing plans
The evaluation process is a crucial aspect of the pilot phase and will
be performed on an ongoing basis to allow initiative to be adjusted as
needed. An evaluation protocol is being designed and will be discussed
on a meeting of interested parties, which is planned for the fall of 1998.
The evaluation of the pilot phase will include the following disciplines:
* Economic and pharmaco-economic
* Clinical
* Epidemiological
Social and behavioural
* Logistical
* Selection of patients
* The subsidy mechanism
Status Report on the Pilot Countries
The Cabinet has approved the proposal of the Ministry of Health to proceed with the implementation of the Drug Access Initiative and establish the Advisory Board. The Minister has appointed officially the 14 members of the Advisory Board as well as the national co-ordinator of the Initiative.
The Advisory Board held its first informal meeting on April 30, 1998 and approved the final selection of eight Category A referral centres and 12 Category B follow-up clinics. There are also 90 Category C primary care centres to be included. The national co-ordinator will assess whether the referral centres have the capacity to start supplying antiretrovirals and other sophisticated drugs to patients immediately, or if there will some delay. Product demand estimates have been finalised and were approved by the Advisory Board during the second meeting, which was held on June 9. Orders have been placed with the companies and the first batches of medications are expected to arrive around the end of June, just before the Geneva AIDS conference.
The Category B and C centres selected for the initiative include those which are currently participating in a World Bank project (STI project), which has provided a loan aimed at making available, on a country-wide basis, drugs for prevention and treatment of opportunistic infections and STD's. The co-ordinators of this STI project and the Drug Access Initiative will work together to harmonise the needs estimating, procurement and distribution of the products.
Through the STI project the government of Uganda will be using public funds for drugs targeting opportunistic infections and STD, and will provide the proper framework for a rational prescription and use of antiretrovirals. However, the government will not subsidise antiretrovirals. These will be purchased at substantially reduced costs by individual patients or through corporate/collective arrangements such as private insurance. The cost level of double combination therapy will be within the reach of civil servants and people working in the corporate sector who cannot afford it at the present time.
Clinical management guidelines have been established that include the choice of drug regimens to be used for opportunistic infections and STDs, as well as for antiretroviral therapy. The guidelines will be distributed widely and will used as the basis of the clinical training workshops.
The non-profit company has been established and is registered under the name "Medical Access Ltd." (MAL). Directors have been nominated by Glaxo-Wellcome, Bristol Myers and Janssen. Additional board members representing other pharmaceutical companies will be appointed. The Manager of MAL has been appointed following the approval of the Director General of Health.
The manager has finalised the following issues in order to make MAL fully operational:
The Advisory Board has been operational since January 1998 and was formally appointed in March 1998. Six referral clinics have been selected and 13 follow-up clinics identified where drugs for opportunistic infections will be made available and where patient management and compliance can be assured. Needs estimates have been completed and the first shipments of drugs have now been delivered and are being distributed.
The non-profit company, Medical Access C.I., has been formed with Directors nominated by Glaxo Wellcome, Bristol Myers and Pfizer. The manager is working full-time. He works closely with the coordinator of the Initiative.
Cote d'Ivoire already has a large publicly-funded tuberculosis programme, and programmes covering access to drugs for opportunistic infections and STDs are being implemented. In addition, the government of Cote d'Ivoire has allocated US $1 million for the initiative to purchase antiretroviral drugs. Additional funds to treat women during pregnancy for prevention of mother-to-child transmission, as well as to provide them with antiretroviral treatment after delivery, will be made available through the International Solidarity Funds. These funds are intended to subsidise antiretroviral therapy to people who still cannot afford them despite the substantial reduction on costs. An independent dispensation committee will be established to ensure an equitable and transparent allocation of these funds. Antiretrovirals will be also purchased by individual patients or through corporate/collective arrangements such as private insurance.
Clinical management guidelines have been established, including the choice of drug regimens to be used for opportunistic infections and STD's as well as for antiretroviral therapy. The guidelines are being printed and will be distributed widely.
In the first visit of the UNAIDS team, an action plan was established with the government which sets out the specific activities which should be considered in the implementation of the Initiative. A National Workshop was held on 6-7 June 1998 to finalise the action plan and establish the Advisory Board and clinical management guidelines.
The state run health system provides a mechanism for the importation of medical products at subsidised prices which does not require the establishment of a non-profit company. Imports of HIV/STD drugs will be made through one of four national import companies.
No decision has been made at this stage with respect to the allocation of public funds. A further visit will be made by UNAIDS in August to progress the implementation phase.
The UNAIDS team visited Chile in April 1998 and prepared an action plan with the National AIDS Programme, which was submitted to the Minister of Health. The Advisory Board will be established shortly. The main issue in Chile is availability of antiretrovirals, since drugs for prevention and treatment of opportunistic infections and STDs are already available in health care centres.
Import duties and taxes (approximately 30%) are levied on all pharmaceutical imports. The government is considering a proposal from UNAIDS that products to be supplied under this pilot project be imported through the UN system and exempted from duties and taxes until a longer term solution could be found.
Approximately 600 patients are currently receiving antiretrovirals that are subsidised by the government. It is anticipated that the new arrangement, together with the pharmaceutical companies' subsidies, will enable the government to subsidise treatment for the entire 1,500 patients who are estimated to require antiretroviral therapy in Chile.
UNAIDS will assist the government in an economic evaluation of direct cost savings arising from the reduction of opportunistic infections and increased normal activity of the patients. Discussions have been held with both private and public health insurance companies regarding their involvement in the project.
Pharmaceutical
Companies Involvement
Six companies have confirmed their participation in the initiative:
Discussion:
Dr Saba clarified that the studies would involve all the players (including
private, community and formal) in the health systems who would all work
together with this initiative. He stressed that the figures regarding patients
who will benefit from the programme are only rough estimates.
The UNAIDS programme was planned with the country's government and implemented by the country with a long-term commitment to ensure sustainability. The initiative is not a UN project, though the UN will facilitate implimentation. The first pilot phase would last two years and an evaluation would then be carried out to improve and extend the programme.
A question was asked about the need for training in sophisticated care and the fact that even after three years, there is still a lot that is not known about drugs for HIV in developed countries. There was a request for clarification about on-going monitoring of drug use and side-effects and resistance patterns. Dr Saba said specific guidelines for treatment and training had been drawn up. On monitoring and evaluation, a database would be kept at the hospital with parameters related to patient and prescriber numbers. In addition, one of the participating pharmaceutical companies will facilitate and monitor resistance tests. In regard to compliance, epidemiological studies, both quantitative and qualitative, will be undertaken to evaluate this too.
Dr Saba said that for the treatment of opportunistic infections and STD control, about 30,000-40,000 patients in each country would benefit. However, the numbers of patients receiving ARVs would be limited initially to about 2,000-3,000 in each country for the reasons of cost and infrastructure.
