Memorandum submitted by Merck & Co
Inc
SUMMARY
1. Merck has been heavily involved in HIV/AIDS
programmes across the world. Throughout Merck's involvement in
such projects, we have developed a valuable understanding of what
factors make a programme work, what local barriers need to be
overcome, and where improvements for future work need to be made.
2. Our participation in programmes alongside
governments and the voluntary sector allow us to provide evidence
to the Committee on how HIV and ARV projects work in practice.
Our submission details the lessons we have learnt, and which areas
must be improved.
3. In our submission, we identify the key practical
steps that together can achieve target seven of the Millennium
Development Goals. HIV/AIDS programmes must be country-led and
require high level political support from domestic governments
if they are to succeed. Schemes cannot be effectively imposed
on nations if they are to deliver improved care for patients.
Partnerships have a crucial role—a link up between government,
voluntary organisations and industry will deliver considerably
more than the sum of the parts. Also of critical importance is
ensuring a balance between provision of ARVs, availability of
testing, tackling stigma, and overcoming other social barriers.
4. We also identify specific work streams which
are critical to improving ARV delivery. These include increasing
local capacity, including recruitment and training of health professionals,
and improving the infrastructure for healthcare provision.
5. There is a need for HIV/AIDS programmes to
take full account of the different service needed for children,
and devising methods of engaging with entire families affected
by HIV are necessary to increase adherence rates amongst young
patients.
6. While the focus of this Select Committee inquiry
is the provision of ARVs, it is right that the balance between
treatment and prevention is included in the areas of focus. Merck
is a strong advocate of prevention strategies—individuals
knowing their HIV status is one of the most important steps that
can be taken to improving prevention rates.
7. Finally, we offer some thoughts on where current
schemes, including those in which we are involved, are not providing
the results needed. Dealing with the stigma of HIV, and utilising
the network of traditional healers are particular areas which
programmes are not sufficiently utilising.
INTRODUCTION
8. Merck & Co., Inc welcomes the opportunity
to submit written evidence to the International Development Select
Committee inquiry into the provision of anti-retrovirals.
9. As a research driven pharmaceutical company,
Merck is committed to improving people's health and access to
healthcare and medicines. The company's primary role in addressing
the challenge of HIV/AIDS throughout the world is a commitment
to discovering, developing and distributing new HIV/AIDS medicines
and vaccines. Having already discovered two widely used HIV/AIDS
treatments, CRIXIVAN (indinavir sulphate) and STOCRIN (efavirenz),
we continue to search for more effective anti-retroviral treatments
and simplified dosing of current treatments. We also have a research
program devoted to finding a safe and effective HIV vaccine, with
a candidate now in a phase II proof-of-concept trial (in collaboration
with the HIV Vaccine Trials Network). Merck is also committed
to making our medicines more accessible, whilst helping to build
the capacity to enable medicines to reach those who need them.
10. Merck has long been a pioneer in developing
public-private partnerships to foster access to medicines and
vaccines in developing countries around the world. Our efforts
to address global health care challenges go beyond the research
and development of medicines—our primary contribution—to
seeking out and supporting partnerships that provide disease education,
prevention and care and help to foster sustainable access to medicines
in the developing world. Public-private partnerships that combine
public sector support with targeted private sector resources can
radically increase people's access to international standards
of care. When the right policies are in place, and with the right
commitment, it is possible to make great strides in the access
to treatment and care for people living with HIV/AIDS.
11. The African Comprehensive HIV/AIDS Partnership
(ACHAP), initiated in Botswana in 2000, is the first comprehensive
HIV/AIDS prevention and treatment programme ever undertaken in
Africa. Merck works in partnership with the Government of Botswana
and the Bill & Melinda Gates Foundation to build institutional
and management capacity, strengthen Botswana's health care system,
promote behaviour change and support grassroots efforts to tackle
HIV/AIDS. Merck and the Gates Foundation each pledged $50 million
to ACHAP to support, develop and finance effective, sustainable
and locally driven HIV/AIDS programmes. Merck is also donating
its ARV medicines for the Botswana government's national treatment
programme.
12. Merck is also involved in a series of other
HIV projects. In May this year, Merck announced a new public-private
partnership with China's Ministry of Health that will provide
HIV/AIDS prevention, patient care, treatment and support in Liangshan
Prefecture, Sichuan Province. We have also been working with the
Romanian government since 1997 to increase access to treatment
and care for thousands of Romanian children and adults living
with HIV/AIDS; as a result of this collaboration, Romania is now
one of the few countries in the world able to provide universal
access to antiretroviral treatment to those HIV-positive people
who require it.
13. Merck makes no profit on the sale of its
current HIV/AIDS medicines in the world's poorest countries and
those hardest hit by the pandemic. By the end of June 2005, more
than 360,000 patients in 76 developing countries were being treated
with regimens containing our ARVs.
14. With this in mind, we feel we are in a strong
position to contribute to the questions posed by this consultation.
We believe that our experience and the lessons learned from our
involvement with international HIV projects has given us insights
into what makes such programmes work, and what barriers must be
overcome. Our projects don't provide all the answers, but we regard
our experiences as being of considerable practical value to others
when rolling out HIV/AIDS schemes in other countries.
ADDRESSING THE
HIV/AIDS PANDEMIC: WHAT
ARE THE
PRIORITIES IN
2006?
Progress on achieving target 7 within the 6th
MDG
15. Based on the experiences that Merck has had
over the past several years in working together to fight the HIV/AIDS
epidemic with partners like the Government of Botswana, the Government
of Romania, the Bill & Melinda Gates Foundation and many others,
there are several key practical lessons that, taken together,
will help to maintain progress toward achieving this important
target of the Millennium Development Goals:
16. High-level political commitment and engagement
is critical. Without political will on the part of national
leadership, success is unlikely. This is clear from global experience
with the HIV epidemic: the countries that have made significant
progress—Botswana, Brazil, Senegal, Thailand, Uganda—could
count on the unequivocal commitment of senior political leaders.
17. Partnerships have a key role to play in
marshalling the necessary resources and expertise. It is tempting—and
sounds efficient—to try to go it alone. But our experience,
first with the Merck MECTIZAN Donation Program for preventing
river blindness and then with the Botswana/Gates/Merck partnership,
shows that it is critical to work closely with nongovernmental
organizations that were already delivering care to remote villages
and with government health officials to ensure that the program
was effectively integrated with the national health system. We
learned similar lessons in Botswana, where the multisectoral approach
coordinated by the government has mobilized community groups and
other sectors of civil society to help in the fight against HIV/AIDS.
These experiences have led us to the belief that involving more
partners, bringing local ownership and complementary expertise,
makes success more likely.
18. Programs must be country-led to succeed
for the long term. Our collaboration in Botswana is fully
integrated with the government's HIV/AIDS strategy, with regular
reviews with all relevant public- and private-sector partners.
Success is based on common objectives, mutual respect, clear shared
targets and agreed metrics to monitor progress, with transparency
for all stakeholders involved. Working in this way builds trust
and confidence among the partners. But it's important to note
that the agenda is Botswana's agenda, not Merck's, which we have
learned is an indispensable element to sustainable success.
19. Building local capacity is also a critical
element. The MECTIZAN Donation Program, for instance, began
in the late 1980s as a donation program, but it soon grew into
a complex network of interdependent partners who were able to
build public health skills at the community level, so that today
more than 60,000 communities in some of the poorest countries
in the world administer their own MECTIZAN interventions. Similarly,
in Romania and Botswana, when we began we thought that the major
challenges would relate to money and access to medicines. But
to our surprise, the public officials in these countries were
more concerned with training physicians and nurses with the skills
to treat and care for HIV-positive patients; with building hospitals,
treatment centers and testing facilities; with educating teachers
and their students about HIV prevention; and with finding the
means to care for a generation of AIDS orphans. In short, investing
in human resources capacity and health infrastructure were the
main building blocks of success, not just money and medicines.
20. A comprehensive approach is needed to
make real headway against the epidemic. In the Botswana case,
the government's antiretroviral treatment program, probably the
largest in Africa, is really just one part of the complex mosaic
of programs and interventions across the spectrum of prevention,
care, treatment and support. We've learned that treatment is a
keystone of an effective response. Without the availability of
treatment, people are reluctant to go for testing. There is also
concern with stigma and discrimination against HIV-positive people,
which makes the policy of routine testing pioneered by Botswana
all the more important. By routinely offering testing for HIV
within the public health arena, citizens feel empowered to get
tested, knowing that treatment and other post-test services are
available to them. And as more and more people know their status,
the social stigma associated with HIV begins to diminish.
21. Persistence pays off. In establishing
the government's ARV treatment program in Botswana (known as "Masa,"
or "new dawn"), there was a relatively long period of
uptake as the treatment centers were built and patients began
to enroll in the program. During the first year or 18 months of
the program, it might have been halted at any time for seeming
lack of progress. But by being patient and remaining focused on
working out the kinks in the system, the Masa program soon began
to grow exponentially; there are now some 50,000 people enrolled,
with roughly 2,000 patients being added each month. Without the
long-term focus and commitment to persevere, Botswana would not
have been able to make the progress it has so far.
THE DELIVERY
OF ARVS
IN RESOURCE-POOR
SETTINGS
22. Through the various projects Merck is involved
with, we have developed an understanding of what practical steps
need to be undertaken in order to improve the provision of ARVs,
and to raise the standard of care for AIDS/HIV patients.
Capacity building
23. Merck & Co., Inc. believes that capacity
building is key to improved delivery of ARVs in resource poor
settings. The challenges of tackling HIV/AIDS cannot be overcome
solely through the implementation of effective pricing policies
alone. Strengthening the disease management capacity of the developing
world has to be a global priority. Ten critical work streams were
identified to help build Botswana's capacity to provide ARV therapy
to those who need it and these work streams need to be rolled
out across the developing world to assist the delivery of ARVs:
(a) Planning and preparation—conducting
needs assessments, development strategies and implementation plans
(b) Monitoring and evaluation—providing
tools and research protocols
(c) Information, education and communication—to
mobilise the community
(d) Recruitment—recruiting new staff for
the healthcare system
(e) Training—for both new and existing
staff
(f) Laboratory capacity—for testing, monitoring
of viral load and CD4 counts, and research
(g) Physical infrastructure—procuring and
upgrading treatment space
(h) IT—developing and implementing patient,
pharmacy and laboratory IT systems
(i) Pharmaceutical logistics—setting up
drug procurement, storage and distribution systems
(j) Management of ARV therapy services and interfaces
24. ACHAP projects have focused on strengthening
the Botswana healthcare system's skills base through recruitment
and training in managerial, leadership, and clinical and technical
skills. The Botswana Harvard Partnership developed a training
programme and curriculum based on the national guidelines for
management of HIV/AIDS. By the end of 2003 all doctors, nurses,
pharmacists and counsellors in Botswana had attended the locally
run courses.
25. Additionally, Merck personnel across Africa
have helped to train hundreds of company medical directors, laboratory
technicians, nurses and doctors in HIV management and treatment.
For example, the National AIDS Control Program in Rwanda has benefited
from Merck support since 1998. With the goal of strengthening
local HIV expertise and enhancing access to quality care, 12 Rwandan
physicians received MSD-sponsored training and now serve as their
country's referral physicians for ARV therapy. In addition, 136
newly trained health care professionals from the secondary level
of care are providing training to health care workers from primary
health care centres nationwide.
26. Flexibility in approach and considering local
sensitivities are crucial. In Botswana, for example, there are
50 times more traditional healers than medical doctors. To work
in partnership with this influential body, ACHAP seconded a traditional
healer to the government to create a meaningful HIV/AIDS education
programme for the healers themselves, so they could become involved
in advanced HIV care.
27. The success of programmes in Africa, as well
as elsewhere, are dependent on the people of the country—most
of who are affected if not infected, and are often under-paid
and under-skilled—to deliver critical and timely results.
The national priority has to be translated into a personal priority
for government workers; through constant awareness-raising, motivation
and mobilisation, and leaders must demonstrate rapid and decisive
action.
28. ACHAP has supported the provision of treatment
centres and also of laboratory testing facilities. In 2001 the
Botswana—Harvard HIV reference laboratory, one of the largest
and most sophisticated HIV diagnostic and research laboratories
in the world, opened with assistance from ACHAP and other partners.
Since January 2002, 32 treatment sites are now operational across
the country.
29. As of September 2005, more than 51,400 people
had enrolled in Masa and more than 45,500 are receiving
ARV therapy through the program, with more than 2,000 new HIV-positive
patients enrolled in the government sponsored programme each month.[20]
GAPS IN
TREATMENT—CHILDREN
AND VULNERABLE
GROUPS
30. Merck is an active partner in the Global
Alliance on Vaccines and Immunizations (GAVI), an alliance between
the private and public sectors that is committed to the mission
of saving children's lives and protecting people's health through
the widespread use of vaccines. GAVI brings together governments
in developing and industrialized countries, established and emerging
vaccine manufacturers, NGOs, research institutes, UNICEF, the
WHO, the Bill and Melinda Gates Foundation and the World Bank.
Merck remains one of only five major vaccine manufacturers, compared
with several companies who invested in vaccine research 30 years
ago.
31. With respect to HIV treatment for children,
one of the key results of ACHAP in Botswana has been adherence
rates and relatively high enrolment of children, nearly 12% of
the total by early 2004. The introduction of special consultancy
and counselling afternoons for families at many of the treatment
centres helped in achieving these encouraging results. Having
several members of a family on ARV treatment creates a unique
dynamic in terms of adherence management for the entire family.
32. The Dula Sentle project provides care and
support for orphans and single mothers in Otse. The scheme is
now supporting around 200 children.
PREVENTION AND
TREATMENT—ACHIEVING
A BALANCE?
33. While treatment remains crucial to the millions
in Africa affected by HIV/AIDS, the long term solution to the
pandemic must include a strong focus on preventative measures.
Two specific issues which must be addressed have
become apparent to Merck:
34. (i) Know your status
In Botswana, over 85% of individuals still do not
know their status, which limits the ability to plan for and address
the epidemic. If ARV therapy is to be successful, people have
to test proactively and not passively—hence the need for
education and "de-stigmatisation" campaigns. Botswana
pioneered an approach of a routine offer of HIV testing whenever
people had interactions with the healthcare system. Individuals
could opt out, but the end result was a quantum leap in the number
of Botswana who knew their HIV status and could then take advantage
of a package of post-test services, whether they were HIV-negative
or HIV-positive. While there were "teething" problems
at the start, and some local and international experts criticised
the program for not immediately delivering the advances in testing
that were hoped for, Botswana's approach to routine HIV testing
is now widely recognized, and was incorporated into the new UNAIDS
policy on HIV testing.[21]
35. At the same time, the success of the treatment
programme is having a knock-on effect on helping with prevention,
overcoming stigma and encouraging people to test and to get to
know their status. The experience in Botswana suggests that knowledge
of status empowers people to be more invested in doing something
about it: negative people to stay negative and positive people
to seek timely and appropriate services.
36. (ii) Broad engagement across civil society
Another important example of how Botswana has implemented
a broad range of information, education and communication activities
to promote HIV prevention is the teacher capacity building programme,
designed to mainstream issues of HIV education in middle school
classrooms. In conjunction with UNAIDS, ACHAP developed a programme
modelled on a similar initiative in Brazil called TV Escola, providing
interactive, distance learning for teachers, via television programmes.
The programme targets stigma within educational establishments
by facilitating free and informative discussions. This is an example
of an initiative which is easily transportable, and with effective
coordination can be replicated anywhere around the world. The
500 schools participating in the program today represent 68% of
all educational institutions in Botswana and more than 4,000 teachers.
37. The success of ACHAP also demonstrates that
grassroots engagement has to be central to all initiatives. ACHAP
provides funding for small community based initiatives, for which
NGOs and community based organizations apply including activities
such as: HIV/AIDS awareness, support and counselling, commercial
sex worker interventions and free condom distribution.
AREAS FOR
FURTHER DEVELOPMENT
38. As shown above, ACHAP can point to a number
of successes, for example, in providing training to health professionals
in Botswana, and in supporting the provision of treatment centres.
However, there are other areas where aspects of the ACHAP still
present challenges: these lessons are also key learnings to take
on board to improve projects in the future.
39. For instance, while ACHAP was sensitive to
local practices and took some steps to involve traditional healers,
they could have been included more systematically. As a result,
the resource of the healers is not being fully utilised.
40. A major problem in combating HIV/AIDS is
the stigma that is still associated with the disease. ACHAP has
begun to address this issue, but more work needs to be done on
this complex set of psycho-social issues. While elements of the
programme have helped to reduce stigma indirectly through the
availability of universal access in Botswana, there has not been
a specific focus on how to combat this obstacle. Certainly it
is a complex social barrier to treatment and there are no quick
or easy answers.
41. Some argue that the greater availability
of highly-active antiretroviral treatment (HAART) leads to disinhibition
or what is known as "HAART optimism," but there is relatively
little concrete information on the relationship between treatment
availability, behaviour change and the effectiveness of prevention
interventions. In fact, some operation research in Cote d'Ivoire,
Tanzania and early data in Botswana indicate the contrary—that
patients enrolled in ARV treatment programmes actually adopt low-risk
behaviours. For future work in Africa, projects must start to
address these questions with robust methodologies and consider
how "de-stigmatisation" programmes can be rolled out
to help increase the uptake of HIV/AIDS programmes that are available.
CONCLUSION
42. As indicated above, Merck's experience in
a range of public/private partnerships to help strengthen the
response to the HIV/AIDS epidemic has led us to a series of key
lessons that apply to achieving the 3 x 5 targets, as well as
the new G8 commitment to universal access by the year 2010:
(a) High-level political commitment and engagement
is critical.
(b) Partnerships have a key role to play in marshalling
the necessary resources and expertise.
(c) Programs must be country-led to succeed for
the long term.
(d) Building local capacity is a critical element.
(e) A comprehensive approach is needed to make
real headway against the epidemic.
(f) Persistence pays off.
43. Taken together, these six elements provide
a proven prescription for success in HIV/AIDS and other global
health programs.
44. Of course, that's easy to say, while making
progress on the ground is complicated and sometimes chaotic. But
an HIV/AIDS programme that brings resources and partners together
in the way sketched above, drawing on the ingenuity and commitment
of all who have something to contribute, will lead to robust results.
From a programmatic perspective, the most important barriers to
universal access/adherence to ARV treatment are: HIV testing,
stigma and discrimination, training of health care workers, involvement
of traditional healers, providing nutritional support, treatment
readiness of the community, and laboratory capacity (biochemistry/immunology/virology).
45. Progress is possible, with the right level
of political commitment, the right policies, and the right partners.
These recommendations are congruent to a large degree with the
HIV/AIDS policies articulated by DFID on behalf of Her Majesty's
Government, and should continue to inform actions taken by DFID
and other UK agencies to implement these prescriptions through
collaborations on the ground in resource-constrained settings.
46. Merck would welcome the opportunity to explore
these issues further with members of the International Development
Committee.
November 2005
20 For additional information on these programs, see
Front Line Against the War on HIV/AIDS in Botswana, available
at: http://www.achap.org/downloads/War%20Against%20HIV_Aids.pdf Back
21
See the discussion in Philip Nieburg, Thomas Cannell and J. Stephen
Morrison, Expanded HIV Testing: Critical Gateway to HIV Treatment
and Prevention Requires Major Resources, Effective Protections,
Washington, DC: Center for Strategic and International Studies,
January 2005, esp pages 7-11. Back
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