SADC principles for negotiation with drug companies
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Hi all,
Below (apologies for the length of the document) is the SADC document
on principles to guide negotiations with drug companies, as obtained
from Dr. Balfour <thuthb@hltrsa2.pwv.gov.za> at the SADC Health Desk.
Regards,
Andy Gray
mailto:andy@healthlink.org.za
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PRINCIPLES TO GUIDE NEGOTIATIONS WITH PHARMACEUTICAL COMPANIES ON
PROVISION OF DRUGS FOR TREATMENT OF HIV/AIDS RELATED CONDITIONS IN
SADC COUNTRIES
1. INTRODUCTION:
The provision of treatment for HIV/AIDS -related conditions has re-
cently put SADC countries in the spotlight. The treatment includes
drugs for opportunistic infections, antiretroviral therapy for treat-
ment of HIV/AIDS and for mother -to- child- transmission (MTCT).
In the past two years, many offers have been made to various SADC
countries by pharmaceutical companies for free drugs or reduced
prices on the drugs. The duration of the offers and conditions at-
tached have never been totally made clear by the companies.
The most publicised offer was when the Joint United Nations Programme
on HIV/AIDS (UNAIDS) announced that a new dialogue had begun between
five pharmaceutical companies and United Nations organizations to ex-
plore ways to accelerate and improve the provision of HIV/AIDS-
related care and treatment in developing countries.
The pharmaceutical companies involved:-
Boehringer Ingelheim
<http://www.boehringer-ingelheim.com/corporate/home/home.asp>
Bristol-Myers Squibb <http://www.bms.com>
Glaxo Wellcome <http://www.glaxowellcome.co.uk/>
Merck & Co <http://www.merck.com/> and
Hoffmann-La Roche <http://www.roche.com>
indicated their willingness to work with other stakeholders to find
ways to broaden access to care and treatment, while ensuring ra-
tional, affordable, safe and effective use of drugs for HIV/AIDS re-
lated illnesses. The companies were offering, individually, to im-
prove significantly access to, and availability of, a range of medi-
cines. Other pharmaceutical companies also expressed interest in co-
operating in this endeavour.
After this announcement by the World Health Organisation (WHO), it
was agreed at the 53rd World Health Assembly in Geneva that African
countries would be represented as regions in any negotiations with
the five pharmaceutical companies.
SADC Health Ministers held two meetings to discuss their response to
the offer. The first meeting, held in Pretoria on 17 June 2000, de-
veloped principles that would be used in any negotiations with the
companies and these are:
a) The prime focus of the negotiations must remain on Sub- Saharan
Africa where the magnitude of the problem is greatest.
b) WHO should become the convening agency for these negotiations in
the light of its broad health mandate and the greater opportunity for
representivity that it can provide through the World Health Assembly.
c) The negotiations should address the overall provision of care for
HIV/AIDS related conditions and must include a consideration of all
the elements related thereto viz. health infrastructure, diagnostic
kits, pharmaceuticals and the technology that would ensure that these
can be safely and effectively administered.
d) All proposals should be centred around the principle of sustain-
ability and on this basis, seek to make drugs both affordable and ac-
cessible.
e) Health ministries should define all research priorities based on
local conditions and national objectives.
f) Those options open to Member States under TRIPS (parallel importa-
tion and compulsory licensing), should not be compromised.
g) Member States should not be required to assume the responsibility
of ensuring that these products do not leave their markets.
The second meeting of Health Ministers, held in Durban on 8 July 2000
was to review progress on the negotiations with the five companies.
At this meeting, Ministers noted that a meeting of representatives
mandated to negotiate with the pharmaceutical companies took place on
30 June 2000 and was attended by a SADC representative. However,
other African blocks had not been adequately represented.
Ministers also noted that some companies had violated an agreement
reached in Geneva in May 2000, that no announcements would be made
without prior consultations with the concerned governments. They fur-
ther noted that pharmaceutical companies were approaching individual
SADC Heads of State or Government with their offers.
Ministers reaffirmed that HIV/AIDS is a serious developmental issue
and that therapy for HIV/AIDS related conditions should be delivered
through sustainable health systems. Ministers further directed that a
minimum package of services that can be used by SADC countries when
negotiating as individual countries or as a collective with pharma-
ceutical companies should be developed. The package would not focus
only on the provision of anti-retroviral drugs, but would address is-
sues of HIV/AIDS -related infections in a holistic way, therefore in-
cluding aspects such as laboratory support, treatment of opportunis-
tic infections, infrastructure, capacity building and monitoring of
drugs, especially antiretroviral drugs.
The minimum package has been developed as principles that will guide
negotiations with pharmaceutical companies that offer free HIV/AIDS
related drugs or reduced prices on these drugs.
2. CHARACTERISTICS OF THE HIV/AIDS EPIDEMIC IN SADC
2.1. Epidemiology Southern African Development Community (SADC) coun-
tries have been hardest hit by the HIV/AIDS epidemic. Current figures
from UNAIDS show that out of a total SADC population of 193 476 000,
eleven million, nine hundred and fifty thousand (11 950 000) adults
and children are living with HIV/AIDS. The HIV prevalence rates in
women attending antenatal clinics in urban areas range from 1.2% -
43%, (See Table 1).
In many countries the HIV/AIDS prevalence rates continue to rise from
year- to- year, suggesting that new infections continue to occur. In
a few, e.g. Zambia, these rates have stabilised but the number of
cases currently present means there will be an ongoing necessity for
the treatment and care of those infected.
2.2 The ideal response to HIV/AIDS
The key elements of any HIV/AIDS programme are prevention of new in-
fections, treatment and care of those already infected and mitigation
of the effects of the disease on individuals and communities.
New infections are prevented in adults who are sexually active
through promotion of abstinence, safe sex practices e.g. use of con-
doms, and treatment of sexually transmitted diseases (STDs). Infec-
tions in newborn babies are prevented mainly through use of antiret-
roviral drugs shortly before, and during labour, and through substi-
tution of breastfeeding with formula feeding.
Those that are already infected can be offered prophylactic treatment
to prevent opportunistic infections e.g. tuberculosis and pneunocys-
tis carinii pneumonia, and definitive treatment as two drug therapy
or triple drug therapy with antiretroviral drugs to keep HIV viral
loads down, maintain a sound immune system and thus prevent infec-
tions. Through triple therapy, developed countries are now preventing
and delaying most deaths from HIV/AIDS.
2.3 Obstacles to the response by SADC countries
Most SADC countries have implemented multisectoral programmes that
promote the prevention of infection, they offer limited treatment for
opportunistic infections, and in some countries pilot projects are
being undertaken on the prevention of mother -to- child- transmission
(MTCT) of HIV/AIDS. No country offers treatment for HIV/AIDS infec-
tion in the public health system. Those that have access to antiret-
roviral therapy obtain it from their medical insurance or as out of
pocket expenses.
The main obstacle to the provision of all the elements of the re-
sponse to HIV/AIDS is limited resources and consequently, poorly re-
sourced health services.
3. HEALTH SERVICE REQUIREMENTS FOR THE PROVISION OF ANTIRETROVIRALS
To provide antiretroviral therapy a number of requirements have to be
fulfilled for the programme to be effective. Those that need treat-
ment have to be identified, a decision has to be taken that treatment
has to be initiated, the drugs are administered and progress on ther-
apy is monitored.
3.1 Identification of candidates for treatment
Candidates for treatment of HIV/AIDS can only be identified after
they undergo a test for HIV. A voluntary counselling and testing
(VCT) programme is thus essential. The requirements for such a pro-
gramme are trained counselling and medical staff, trained laboratory
staff and test kits, and a functioning health system to ensure that
tests are made available in good time to clients.
3.2 The decision to start treatment
Treatment for the prevention of opportunistic infections and treat-
ment for HIV/AIDS is dependant on various factors. These are HIV/AIDS
viral load, the CD 4 count, and the clinical condition of the pa-
tient. To interpret the stage of disease and need for treatment, cli-
nicians have to be trained using recognised clinical guidelines. So-
phisticated laboratory facilities, and more substantial financial re-
sources, as the tests are expensive have to be available.
3.2.1 Drugs used in treatment of HIV/AIDS
The drugs used in HIV/AIDS are in four categories: Anti-infective
drugs for opportunistic infection, Anticancer drugs for commonly oc-
curring cancers related to HIV/AIDS, Palliative treatment for pain
and other symptoms that have to be relieved, and Antiretroviral
drugs.
The most expensive are the antiretroviral drugs, anticancer drugs and
some of the anti-infective drugs. Training in the rational use of the
drugs using clinical guidelines and treatment protocols is important.
3.3 Monitoring the effects of the drugs
Antiretroviral drugs, anticancer drugs and some of the anti-infective
drugs need constant monitoring of the drug levels to prevent toxic-
ity. The clinical response of the patient is also monitored using
HIV/AIDS viral load levels, CD4 counts and other haematological tests
for toxicity. Laboratory facilities with specialised equipment for
these tests are thus again essential. This has to go on at least
twice to four times a year for each patient.
4. ETHICAL CONSIDERATIONS IN HIV/AIDS TREATMENT
The treatment of HIV/AIDS is resource intensive and the ethical con-
siderations include, the diversion of resources to HIV/AIDS only, and
the selection criteria for offering treatment to some citizens and
not others.
A more fundamental issue is singling out HIV/AIDS among all other
conditions competing for resources in developing countries. In these
developing countries health systems as a whole are structurally con-
strained. There is lack of infrastructure such as laboratory facili-
ties, lack of trained human resources, lack of equipment and lack of
supplies like drugs and other diagnostic and therapeutic agents. The
whole health system is thus in need of strengthening and support, and
singling out one condition in a dysfunctional system does not offer a
viable solution to existing problems.
Any treatment that is offered for HIV/AIDS would of necessity mean
that a country will afford to treat a few patients and the selection
criteria for providing or not providing treatment are fraught with
moral and ethical dilemmas. These selection criteria therefore have
to be established and made clear to all stakeholders, before treat-
ment is offered.
5. ESSENTIAL TREATMENT PACKAGE FOR HIV/AIDS- RELATED CONDITIONS IN
SADC COUNTRIES
5.1 Introduction
While offering treatment for HIV/AIDS-related conditions, it must be
clear that this is provided within an integrated health system that
follows the principles of primary health care, it is located within a
comprehensive programme for the management of HIV/AIDS using public
health principles and that the provision of treatment requires addi-
tional resources.
The other components of HIV/AIDS prevention programmes, i.e. preven-
tion of primary infection, and care for those infected should not be
compromised, but instead, should be strengthened.
5.2 Strengthening health systems
A functioning health system to support the provision of drugs for the
treatment of HIV/AIDS -related conditions is a prerequisite and these
are the essential elements of such a system:
5.2.1 Information, education and communication (IEC)
IEC that is culturally appropriate should be offered for the follow-
ing: Prevention of HIV/AIDS in general In preparation for voluntary
counselling and testing, and To improve the patient's understanding
of the treatment that will be offered.
The provision of treatment should not detract from the basic message
that prevention of the disease is better that a "cure". Experience in
other countries shows that with the availability of triple therapy
for control of HIV/AIDS infection, the incidence of new cases of the
disease rises. Prevention messages thus have to be maintained and re-
inforced.
The first step to treatment is VCT, thus again, IEC is essential to
give the client information on the implications of both the negative
and the positive test result.
IEC is once more necessary to educate patients on the mode of action,
the doses, side effects and monitoring required when taking treat-
ment. Compliance with treatment is the benefit that will be gained.
5.2.2 Adequate capacity building (training of personnel)
Personnel has to be trained for: VCT, laboratory testing for HIV/AIDS
and monitoring tests and clinical management of HIV/AIDS. The provi-
sion of treatment that can significantly prolong survival will lead
to an increase in the number of people willing to submit themselves
to testing. More staff will thus need to be trained to meet this in-
creased demand.
Laboratory workers have to be trained in doing HIV tests, both rapid
and confirmatory tests. The laboratory monitoring of virological and
immunological indices that show the patient's response to therapy
will need additional specialised training. Special training pro-
grammes will thus have to be designed and implemented.
Clinicians have to be trained in the diagnosis, treatment and moni-
toring of patients on HIV/AIDS-related therapy. This includes watch-
ing out for clinical and laboratory evidence of the side effects of
the drugs.
5.2.3 Provision of infrastructure and equipment
Specialised laboratory equipment for measuring viral load and CD 4
lymphocyte levels is necessary to monitor a patient's response to the
drugs.
There is a need for further investment in laboratory facilities that
meet the standard of equipment to be used for testing.
5.2.4 Provision of test kits
Test kits for diagnosing HIV/AIDS are essential. These are rapid
screening tests and confirmatory tests. Currently, these tests are
unaffordable if they are to be used to screen for public health pur-
poses. The test-kits have to be provided at prices that are afford-
able, to improve access to testing.
5.2.5 Drug supplies
Drugs for the treatment of sexually transmitted infections (STIs),
opportunistic infections, palliative care, anticancer drugs and anti-
retroviral drugs all have to be part of a comprehensive package.
These drugs should all be provided at affordable prices.
Support for efficient storage and distribution of drugs is essential
if the drugs are to reach their target population.
5.3 Maintaining the continuum of care
Most antiretroviral therapy is meant to keep patients healthy for as
long as possible, and is usually provided in a hospital setting. In
the terminal stages of disease, however, most patients are nursed at
home. Home-based care thus needs to be strengthened as part of com-
prehensive care and support, including clear referral systems between
home and the health care facility.
5.4 Occupational safety of health workers
Services for prevention of occupational injuries related to HIV/AIDS
should be provided. Antiretroviral therapy for post exposure prophy-
laxis is essential in such a service.
5.5 Other considerations in accepting offers for HIV -related drugs
Before accepting offers for free drugs or reduced prices of HIV/AIDS-
related drugs, other factors have to be considered. These are sus-
tainability, affordability, accessibility, appropriateness, accept-
ability, and equity.
5.5.1 Sustainability
The provision of any drugs for the treatment of HIV/AIDS-related con-
ditions will create a demand that has to be maintained even when the
period of the offer expires. It is therefore imperative that sustain-
ability beyond the period of the offer is addressed.
Any drug offered at a reduced price or free should be made available
to the recipient country for a minimum period of 5 years.
5.5.2 Affordability
Ultimately, the drug offered must be affordable to the country after
the offer period expires. All methods of making the drug affordable
should be explored, including differential pricing, parallel importa-
tion and compulsory licensing for the drug.
Second generation drugs that are less toxic will come on the market
and it is important that countries that accepted offers for pharma-
ceuticals should have these less toxic drugs available at affordable
prices.
5.5.3 Accessibility The drug should be accessible to all citizens,
i.e. all citizens have an equal opportunity to get treatment. This
means the drug has to be available at such quantities that the public
health system in the country has enough supplies to treat all citi-
zens who qualify for treatment according to the treatment guidelines.
5.5.4 Appropriate
Drugs offered and accepted should be those that do not require spe-
cial or additional resources for administration. If this is the case,
the additional resources or skills to administer the drug should be
provided. Drugs used should be in use in other developed and develop-
ing countries.
5.5.5. Acceptable
The community and health workers in the recipient country should con-
sider the treatment acceptable for use.
5.5.6 Equity
The provision of the treatment for HIV/AIDS should not divert re-
sources from other services and conditions that are prevalent in the
country. All citizens should have equal access to the treatment.
6. CONCLUSION
The offers for free drugs or reduced prices of HIV/AIDS -related
treatment, especially treatment that is currently not affordable to
SADC Member States have to be approached with caution. Any offers of
such a nature have to be accepted while ensuring that there is equity
in the allocation of health resources, that resources are not unduly
diverted to one condition, that the requirements for embarking on
such a programme are provided for and there is a sustainable supply
of the drug.
--
Andy Gray
Discipline Chair:
Pharmacy Practice School of Pharmacy and Pharmacology
University of Durban-Westville
PO Box 1580 Westville 3630
South Africa
Tel: +27-31-204-4358
Fax: +27-31-204-4792
mailto:andy@healthlink.org.za
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