HIV and AIDS Control and Prevention Act: Ethical Challenges and Legal Gains in HIV Control in Kenya Linda Were* and Simon K. Langat# (* University of Nairobi, Institute of African Studies, email: linda1were@yahoo.com # National Council for Science and Technology, email: langat@scienceandtechnology.go.ke) Abstract Kenya passed legislation in 2006 that was meant to facilitate the control of HIV/AIDS. The Act has been lauded as an important milestone in the difficult road towards the containment of AIDS in the country. Some sections of the Act were made operational while some were not. There has been a general reduction of prevalence and what seems to mean that there has been great success in the fight against the spread of HIV in the country. This study sought to establish the contribution of the Act to the control of HIV spread using the assessment of those who are closely associated with the implementation of policies that have since been put in place pursuant to the Act. The findings indicate that most are in agreement that the Act has been useful; some have challenged the Act on account that it is not useful and that it may interfere with people’s rights, final decisions for which are yet to be made by the courts. Others however think that the success was largely attributable to the measures that had been in place long before the law was passed and that control activities had developed a motion of their own leading to the successes currently seen. The paper argues that the law simply reinforced what had been started earlier on the basis of common moral principles; there are no new moral dilemmas brought in by the Act save for legal puzzles that can be resolved without throwing out the Act or incapacitating it with restrictive and damaging deletions on any of its sections. 1 1.0 Background HIV/AIDS is a global issue that has received a lot of attention across the world and a large number of people are affected by it. Equally, there has been an unprecedented response and effort to fight the scourge. The biomedical, social and economic efforts have shaped our approach to disease control and social reactions to problems afflicting mankind today. HIV/AIDS has been a major problem in Africa and especially Sub-Saharan Africa. Kenya is one of the world’s countries hardest hit by the HIV/AIDS pandemic. An estimated 1.5 million people are living with HIV, around 1.2 million children have been orphaned by AIDS and in 2009, 80,000 people died from AIDS related illness.1 The statistics from the Kenya demographic health survey 2008-2009 shows that the rate of infection is 6% of Kenya adults age 15-49,this is lower than in 2003 when it was 7%.Women are disproportionately affected by HIV. According to KDHS in 2008 HIV prevalence among women was twice as high as that of men at 8% and 4.3%,the disparity is even greater in young women aged 15-24 who are four times more likely to become infected with HIV than men of the same age. Adult HIV prevalence is greater in urban areas 8.4% than in rural areas 6.7%.However as around 75% of people in Kenya live in rural areas, the total number of people living with HIV is higher in rural settings( 1 million adults) than urban setting which is 0.4 million adults.2 The government of Kenya has had a history of several interventions and measures since HIV was first identified in Kenya in the early 1980s.According to Sessional paper no. 4 1 Ministry of Health -Strategic Plan for the Kenya National HIV/AIDs and STDs Control Programme 1999-2004 2 Government of Kenya (July 2008). Kenya AIDS Indicator Survey, 2007. www.aidskenya.org/public_site/.../KAIS_Preliminary_Report.pdf, 2 of 1997 on AIDS in Kenya, the Government of Kenya responded to the epidemic when it was first recognized by establishing the national AIDS committee and development of strategic plan. The national AIDS committee was established in 1987 to advice the government on all matters related to the prevention and control of AIDS. An AIDS programme secretariat was established to coordinate activities. These steps led to the establishment of the Kenya National AIDS control programme in 1987.It was followed by the development of a five year strategic plan called the medium term plan (1987-1991).3 This plan emphasized creation of awareness about AIDS, blood safety, clinical management of opportunistic infections and capacity building for management of AIDS control programme at national level. The main strategies pursued were prevention of sexual transmission, prevention of transmission through blood, prevention of mother to child transmission and disease surveillance. By 1991 AIDS was recognized not just as a health issue but a developmental problem requiring the participation of all other sectors and thus the second medium term plan (1992-96) continued to pursue the same strategies but in addition emphasized the need to involve all sectors in HIV prevention in order to mobilize broader national response against the epidemic. The Government at the time also took note of the scientific findings that, sexually transmitted diseases facilitated the spread of HIV. This led to the integration of STD and AIDS control hence the establishment of NASCOP in 1992. According to the sessional paper no.4 there was need for a multi-sectoral strategy which was foreseen at the inception of national Aids control programme in 1987 and hence this led to the establishment of the National AIDS Council which would enable the Government to overcome most of these constraints since NASCOP as a department of the Ministry of Health, could not be able to marshal other sectors involved in AIDS prevention and control. The national AIDS council would expedite HIV prevention and control Activities through formulation of appropriate policies, establishment of an appropriate institutional framework for multisectoral AIDS control including care of people affected and coordination of all actors which include government departments, non-governmental organization, community organization, religious organization, private sector and donors among them. 3 Sessional Paper No 4 1997 3 based In 1997, parliament approved the sessional paper no.4 of 1997 on AIDS in Kenya which provided a policy framework to guide all partners in Kenya’s response to the challenges of HIV/AIDS. This brought in a new window of hope in the areas of advocacy and policy development, prompting intense national debates about factors leading to the spread of the disease and the effective strategies for prevention and control which in turn led to renewed and vigorous political commitment to reducing the spread of HIV/AIDS.4 In 1999 President Moi declared HIV/AIDS a national disaster and announced that a National AIDS Control Council (NACC) would be established immediately. As a result of devastating effects of HIV, the government through a legal notice no.170 of the State Corporations Act established the NACC in November 1999 to coordinate, supervise and monitor implementation of multisectoral national HIV and AIDS response. NACC developed the Kenya national HIV/AIDS strategic plan with its theme being: to reduce HIV/AIDS and poverty. Kenya national HIV/AIDS strategic Plan aims to promote behavior change and hence came up with the now famous “ABC” approach. It stands for, Abstinence, being faithful and using a Condom. This was to promote abstinence, and or consistence in practice of safer sex among those who are most vulnerable and the general population. In further efforts to continue the fight against HIV/AIDS, the ninth Parliament in the 2006, enacted the HIV and AIDS Prevention and Control Act, No. 14 of th 2006, which was assented to by the President on 30 December, 2006.With its aim to provide for the protection and promotion of public health, appropriate treatment, counseling, support and care of persons infected or at risk of HIV infection. Expectations from the Act The Government appointed a team to draft the legislation and coordinate stakeholder consultations and ensure widespread support for the new law. The team took its time and developed a draft that was later discussed and passed in parliament. The country and indeed the affected groups, healthcare givers and general population appreciated the enactment. The following were the expectations. 4 Provide a framework for prevention, management and control of HIV/AIDS Kenya National AIDS strategic plan 2005-2007 4 Give impetus to those pushing for holding the government accountable on the issue of universal access and treatment for all people living with HIV/AIDS (PLWHIV) through protection and promotion of public, treatment support and care of infected persons Overview Around the world, different nations have come up with statutes to safeguard people living with HIV/AIDS and at the same time uphold human rights. The development of legal instruments on HIV/AIDS began in 1982 considering the mean time interval between the establishment of a baseline epidemiological data and production of specific health legislation in industrialized countries. In developing countries, legislation started two years later and reached a peak in 1987. Kenya followed suite, in December 2010, when the minister for special programmes put into operation section 14, 18, 22 and 24 while leaving out all other sections. This has derailed several measures hence affecting the efforts made so far in the fight against HIV/AIDS. The objective of this act was to; promote public awareness about the causes, modes of transmission, consequences, means of prevention and control of HIV and AIDS. To extend to every person suspected or known to be infected with HIV and AIDS, full protection of his/her human rights and civil liberties by prohibiting HIV testing save as provided for in the Act; Guaranteeing the right to privacy of the individual, outlawing discrimination in all its forms and subtleties against persons with or persons perceived or suspected to have HIV and AIDS, ensuring the provision of basic healthcare and social services for persons infected with HIV and AIDS. Promote utmost safety and universal precautions in practices and procedures that carry the risk of HIV transmission and positively address while seeking to eradicate conditions that aggravate the spread of HIV infection. Some of these objectives are yet to be met since the act has not been fully operationalised. Section (9) states that a person who offers to donate any tissue shall immediately before such donation undergo a HIV test. There are so many cases of organ transplant that would require regulation by the relevant sections of the Act. 5 Section 31 (1) provides that no person shall be denied access to any employment for which he is qualified, or transferred, denied promotion or have his employment terminated on the grounds only of his actual perceived or suspected HIV status. Section (32) provides that no educational institution shall deny admission or expel, discipline, segregate, deny participation in any event or activity or deny any benefits or services to a person on the grounds only of the person’s actual, perceived or suspected HIV status. Section 33 (1) provides that a person’s freedom of abode, lodging or travel within or outside Kenya shall not be denied or restricted on the grounds only of the person’s actual, perceived or suspected HIV status. Section 35 (1) provides that no person shall be compelled to undergo a HIV test or to disclose his HIV status for the purpose only of gaining access to any credit or loan services, medical, accident or life insurance or the extension or continuation of any such services. However it is provided in Section 35 (2) that an insurer, reinsurer or health maintenance organization shall in the case of life and healthcare service insurance cover, devise a reasonable cover for which a proposer shall not be required to disclose his or her HIV status .This has not been followed up by insurance service providers. Part (7) of the Act creates the HIV/AIDS tribunal. Section gives the tribunal jurisdiction to hear and determine complaints arising from breach of the provisions of the Act, to hear and determine any matter or appeal as may be made pursuant to the provisions of the Act and to perform such other functions as may be conferred upon it by any other written law being in force. It has powers of a magistrate’s court to award damages in respect of any proven financial loss or in respect of pain and suffering and psychological suffering as a result of the discrimination against the complainant. When this section is not put in operation then the whole Act remains useless because even those operational sections depend on it. Research is essential for innovations and improvements in the medical sector. Part (9) of the Act is about research that involves human subjects. Section 9(40) states that no person shall undertake HIV/AIDS related biomedical research on another person or any 6 tissue or blood removed from such person except with the written informed consent of that other person or if that other person is a child with the written informed consent of a parent or legal guardian of the child. This Section is not operationalized thus creating the impression that certain requirements as to consent for testing and confidentiality and biomedical research are not catered for by law for the time being. Section 1 of the Act provides that: “This Act may be cited as the HIV and AIDS Prevention and Control Act, 2006 and shall come into operation on such date as the minister may by notice in the gazette appoint different dates for different provisions.” Tragically, five years later, some sections of the Act remain not operational, it would be important to assess the effect of prevailing situation on the control of HIV. This was the basis of our study and was aimed at assessing the moral issues that underpin the fears informing the minister’s action. Since the whole Act is important and the sections interdependent it should be treated as unitary both in terms of its outcomes and implementation. 3.0 Study objectives The objective was to establish the general contribution of the Act to the control and prevention of HIV/AIDS and to present and discus the impact of the Act on HIV in Kenya. Our Specific objectives were; to document and assess the impact of the Act on HIV control and prevention and to assess the Impact of exclusion of some sections from operation and especially informed consent as it relates to research in sections 39 and 40. These would give us the basis for discussing the moral foundations of the Act and some implications the current implementation situation has brought to bear. 7 4.0 Methodology The study used questionnaires to collect data. Respondents from specific institutions deemed to have useful information were asked to fill in the questionnaire or answer questions in an interview session. The expert sampling method was used for the study. It involved only persons at the institutions that executed the Act, the attorney general’s office, members of ethics committees, government officials that participated in deciding how to proceed with the draft developed by the task force that created it, legal advisors and members of the now disbanded task force and interested parties (stakeholders) like the people living with HIV, (PLWHIV) and other Non Governmental Organization activists. 5.0 Results We received various standpoints on the different issues that were addressed by our instrument. The respondents were persons that had a clear grasp of the Act and the situation in the country since the passage of the Act by Parliament. The sections that were pronounced into operation by the Minister responsible were: section 14, on consent of minors; 18, on results of HIV testing; 22, on disclosure of information; and 24, on prevention of transmission of the virus. The sections that remain non operational include: 4, on education and information; 5, on education in institutions of learning; 6, on education as a health care service; 7, on education in the workplace; 8, on information in communities; 9, on testing of donated tissue; 10, on testing of donated blood; 11, on guidelines for surgical and similar procedures; 12, on penalty for unsafe practices or procedures; 13, on prohibition of compulsory testing; 15, on provision of testing facilities; 16, on testing centers; 17, on pre-test and post test counseling; 19, on access to health care services; 20, on privacy guidelines; 21, on confidentiality of records; 25, on establishment of the tribunal (the tribunal has since been gazetted on 21st July, 2011 hence, all sections of the tribunal are operational). Others were; 31 – 38, on discrimination (part viii); 39 – 42, on research (part ix); and 43 – 46, (part x) on miscellaneous provisions. 8 Some groups in the Kenyan society have gone to court asking to have the sections that were operational declared null and void and inconsistent with the constitution. Those who support the Minister’s action regarding the relevant sections however claim that; the sections secure consensus from stakeholders, prevents abuse of HIV testing while protecting the country and safeguarding respect for the individual; enables the involvement of persons living with AIDS in the prevention of HIV and safeguarding of their rights; encourages people to accept voluntary testing with appropriate counseling. Some felt that the sections especially 22 and 24 need further clarification as the matter can be dealt with in section 26 of the sexual offences Act. Most respondents thought that the measures taken, by the country to control HIV and AIDS have been successful. This is due in part to the results of Kenya Demographic and Health Survey, 20095 and a report, released by the National AIDS and STD Control Programme (NASCOP) in 2010.6 The results indicated that HIV/AIDS prevalence had gone down to 6.2% from 8%. This outcome has been attributed to the NACC strategic plan that was drawn to guide the process of controlling and preventing HIV spread n the country. Respondents describe the situation with words like: “successful, good impact, fairly successful, awareness is high” and that the spread witnessed is due to negligence by some people and not lack of awareness. Awareness levels are placed at 98% of the population by the respondents. Test screening, safe practices and procedures score well with about 60% of the population tested. It has lead to the setting up of many voluntary counseling and testing sites. There are over 1,200 such sites. Policies and guidelines for safe practice have been launched country wide and continue to provide useful services to the population. Confidentiality Respondents associated with implementing institutions reported that the section has been fairly successful. Guidelines that determine the procedure were developed in 2008 and 5 6 Kenya National Bureau of Statistics: Kenya Demographic Health Survey 2008-2009; pp 209-228; 2010 NACC; Kenya Service Provision Assessment Survey; 2010 9 are followed. Staff in the institutions follow and hold that confidentiality if breached would be a violation of their rights thus maintaining a high level of adherence. Respondents from civil society and other institutions not directly involved with implementation of the Act either had no comment or did not know what to report on confidentiality. Some reported that there were dilemmas without any details. Others still, stated that there has not been any significant impact and stigma continues to be a great hindrance to the respect of confidentiality as a right. This was interpreted to mean that persons who would wish to take a HIV test are fearful that the results of his/her test would not be kept sufficiently confidential to stave off any prejudice that may follow a breach of confidentiality. Tribunal A tribunal was announced during the period when material for this article was being collected. All respondents after the announcement noted the same. Some added correctly that the tribunal did not have any budget allocations as yet and that it will be seen in days to come, how it will respond to the issues at hand especially arising from the numerous cases that are pending before it. There are high expectations that the tribunal will address the issues of stigma at places of work, schools and at home.7 The Kenya AIDS NGO Consortium adds that the tribunal will reduce vulnerability by protecting human rights. 8 Discriminatory acts and policies Respondents have some level of expectation that the newly set up tribunal will address the perceived fairness of the Act. Whereas part VIII of the Act is about discrimination in the workplace, restrictions on travel and exclusion from credit and insurance, the respondents do not appear to address the issue of whether there are policies that are contrary to this Act. It is not clear whether or not the respondents regardless of their institutions, have any information on the actual situation regarding the clauses in these sections. One respondent indicates that there has been an increase in discrimination. 7 8 Daily Nation 30/06/2011 Ibid 10 Research Some respondents claimed that the country has the broad architecture necessary for research and that it actively engages in protecting human subjects. Ethics review committees were cited to be doing well in protecting human subjects while however; the Act has not been supportive, as the relevant part was not operationalized nor is it enforceable. Respondents from implementing institutions and civil society that responded to the questionnaire had varying comments, not following any pattern. Operationalization of the Act Apparently, respondents thought that the sections which have not been put into operation should be operationalized. The reasons they offer as to why the sections were not are varied. They ranged from lack of institutional mechanisms and policies for managing the sections to conspiracy by some to frustrate the new law. Civil society respondents stated that the sections would not have influenced behavior positively for the required changes to be realized. Stigma, they claim, drives the breaches of confidentiality. Furthermore, there is no budgetary allocation to facilitate their operations. The tribunal, it was said, would be a less effective alternative to ethics review committees. Other important reactions from those who responded indicate that some activists opposed structured approaches to HIV control and prevention. They do not support routine testing at health care centers, always citing justifications that hinder discussions and progress. Some lobby groups have engaged arguments that are an end in themselves and do not focus on finding useful solutions. Comments from respondents in the implementation side did not differ from those of civil society. Others however reserved their comments, leaving the sections of the questionnaire blank. Implementation and Reactions to the Act Reactions to the possibility of success in implementation and support from different stakeholders were also varied but generally in unison for the different respondents. There 11 is total agreement that the structure that exists for the control of the disease is suitable and effective. Since creation, the National AIDS Control Council has raised the level of consultation with stakeholders leading to success in control. The tribunal is expected to improve the area of human rights and justice. Most respondents believe the public is sufficiently aware of the Act and the people living with HIV in the majority are aware. Government commitment in general was described as lackluster and not consistent yet it is aware, has embraced the Act but has not clearly dealt with the Implications. There are conflicts in some sections namely testing, consent and confidentiality. Civil society and NGO’s welcomed the Act and have high expectations. Insurance service providers have not reacted to the Act. Discrimination is still evident, the confusing unclear response and seemingly imprecise perception is an indication of inertia and slow movement towards acceptance but not rejection. 6.0 Discussion The HIV and AIDS Prevention and Control Act of 2006 was passed with the good intentions of providing measures for prevention and management of HIV as a public health concern. It contains basic prescriptions for public education and information; various procedures and practices, for safety provision including testing and screening; guidelines for privacy; rules for the prevention of transmission; determination of rights and complaints; and guidelines for research amongst others. There are two distinct voices commenting on the Act from the results above. One finds the Act largely successful and well implemented by those to whom it apportions responsibility. The noble aims of this piece of legislation are known widely across the country. On the other hand, there are those who do not see any benefits towards the prevention of HIV, they claim that it is not clear what benefits the conflicting clauses will bring to the control of HIV. The National AIDS Control Council, the lead authority in the implementation of the Act is not created by the Act, rather by an executive legal notice. The NACC predates the Act hence the anomaly. Other institutions include the relevant ministries responsible for health, public security, law courts and the tribunal created by the Act. The tribunal, once 12 it gets into full operational mode will take over all judicial responsibility like the other tribunals set up by the 2010 Constitution of Kenya. Education and Information We look at education and information of HIV as being largely successful in the country. There are activities that went on prior to the Act being operationalized. They were driven mainly by the NACC strategic plan drawn in 20009 and a report from the NACC10.The document was praised within the country and worldwide as a purposeful well-articulated plan. The reduction of prevalence rates can be directly attributed to the plan. The message that has been popularly called “ABC”11 in an ideal situation could eliminate HIV within a specific period of time. The situation in Kenya was not ideal nor was the message faithfully followed by all. Credit however is due to the Government for the persistence in pronouncing the message that made the majority in the population to desire and practice its content to some extent. Thus the policies that were in place to guide the drafting of the law are basically acceptable. It is expected naturally that the development of the Act followed the same policy and reinforces it. Public institutions are created and empowered to pursue what is desired by society and deliver useful outcomes. Safe Practices and Procedures Sections 9 and 10 are categorical about the need to test tissue and blood that is to be donated to other persons. It does not go into details of disclosure of the test nor does it give the donor any option of a choice. It is expected that a donor will accept the test or desist from donating. The protection of an organ recipient is paramount. The demand on 9 Kenya National HIV/AIDS Strategic Plan- Oct 2000 National AIDS Control Council 2000-2005 10 11 NACC; 2009/10-2012/13: Delivering on universal access to services. Nairobi. Abstain, Be Faithful, Condom use 13 the donor is fair as it is an obligation for both the donor and the agent (medical or laboratory worker) to not transmit the HIV virus under any circumstances to a non infected person. This underlines the importance of this clause in the Act. The Act goes further to safeguard the recipient by offering the option of an extra testing for complete avoidance of doubt. The import of this section, {9 (3)} is to absolve the state or any other party involved in the transaction from any blame whatsoever while prohibiting a risky undertaking. The subsequent section on the guidelines on surgical and similar procedures is based on the same reasoning. This part of the Act is therefore designed for the good of the public and the avoidance of error. Test Screening Compulsory testing is prohibited by the Act. The same section in a second clause defines condition upon which no testing can be allowed. These include testing as a precondition for employment, marriage, admission to educational institutions, travel and access to health care/insurance. The next section lifts the prohibition on those who are charged under the sexual offences Act, 2006 {Section 13 (3)}. This window introduces controversies of the sexual offences Act to the HIV and AIDS law. Arguments have been raised by various groups against the compulsory testing under the sexual offences Act. In the case of AIDS Law Project verses the Attorney General, in April 2011, the High Court declined to suspend implementation of section 24 of the Act citing that public interest outweighed the interests of the applicants12. Bwire has examined the sexual offences Act in greater detail and suggests that HIV status be considered an aggravating factor during sentencing using substantive criminal law as recommended by the International Guidelines on HIV/AIDS and Human Rights13 Such controversies besides confusing the public slow down the progress towards the control of the disease. Moral questions must be raised here, should society rely on individual goodwill only for the control of a deadly scourge? Is it to be understood that the Act contradicts itself and perhaps the constitution? What is the best way of resolving moral issues that are encountered in laws that are meant to regulate human behavior to 12 Kenya Law Reports; www.kenyalaw.org; 2011, cited in Daily Nation 9th May 2011; Law Report/II Buluma Bwire; Criminalization of Deliberate HIV Infection in Kenya; Proceedings of the First Biennial HIV/AIDS Conference; May 2011 13 14 protect the population? The argument in the paragraph above on safe practices is valid here and should be upheld. It is the duty of law to set the minimum standard of behavior for all. Consent to HIV testing and Confidentiality The Act guarantees respect for persons regardless of their status with respect to HIV. The section on consent was operationalized and further clarified by the 2008 NACC guidelines on HIV testing and counseling. The guidelines make confidentiality a requirement. Whereas section 20 on confidentiality was not one of the sections operationalized, the Ministry of Health has assumed its responsibility and provided leadership and guidance to the processes related to the section. The overall effect of these activities can be assessed as positive since they were part of what lead to the reduction in HIV prevalence in the country. The state took measures to safeguard privacy by developing guidelines in accordance with section 20 (1) of the Act and by the action of operationalizing section 22. Both sections are in tandem with ethical principles that have for long been held and applied. Respect for persons is a principal to be upheld at all times. The constitution of Kenya underscores the same principle in the bill of rights article 28.14 There is a moral obligation on government to continue ensuring these rights are safeguarded. Prevention of transmission Prevention of diseases is an issue of great public importance. The prevention of infectious diseases is a responsibility of the state. This responsibility empowers the state to take appropriate measures. It is not uncommon worldwide to find states curtailing individual rights in efforts to curb the spread of diseases. The justification for such efforts is found in the common statement that “prevention is better than cure”. Global classification of health services by states is based on the ability of a country to control infectious diseases. The creation of a tribunal gives the Act the versatility it requires to be effective. Although its formation has come more than four years since operationalization of the Act, it is still 14 Constitution of Kenya; Government Printer; 2010; Article 28 15 expected to play a crucial role. The tribunal consists of seven members representing the medical practitioners, legal practitioners and others with skills necessary for the discharge of functions. Gender balance is expected to be maintained at least in accordance with the constitutional requirement of one third. The drafters of the Act did not consider naming people living with HIV, minority groups of whatever other description, persons with distinctive classification as being necessary to be named into the tribunal. Indeed it would be burdensome to introduce such differentiations for the membership of the tribunal. A lean tribunal would be more efficient and versatile to manage. Considering that HIV is just one disease among many, and that successes in other areas of prevention will in future ease the burden on public financing, it would be prudent to maintain a reasonably lean tribunal. We consider discrimination in the work place, education and other places as an important issue in the prevention of HIV. There is no doubt that discrimination exists. This study did not however seek to establish details about discrimination in any of the sectors. We therefore confine ourselves to commenting on the provisions of the Act in so far as the respondents to the questionnaire could highlight. The impact of this section will become clear in the days to come as the tribunal begins to consider the cases pending. Research Section 39 and 40 of the Act address research in HIV and AIDS. It introduces requirements that are standard practice in research and conform to the currently held view that research must be conducted only with due respect for persons, where it would be beneficial and that it is justly executed. The reference to the Science and Technology Act (Cap 250) in section 39 is recognition of the general governance structure for research in Kenya. It is meant to relate research in HIV and AIDS to standard requirements and management of research for HIV and AIDS. Section 40 restates the need for consent for the purposes of using human tissues for research. Anonymous testing is introduced in section 41 for the purpose of public health. It empowers the Minister to make guidelines for anonymous testing. It has been noted by some investigators that the state in Kenya plays a multiplicity of roles in HIV vaccine research (E.A. Oduwo). She attributes 4 roles 16 to the state i.e. regulator, physician, participant and researcher and concludes that this state of affairs leads to ethical challenges and conflicts15. The four roles are however played by different institutions coordinated through the legal statutes that spell out their mandates. The involvement the state is focused on provision of infrastructure, direct funding of research and provision of health services. Thus it would appear that the state is doing all that appertains to research. The state should, be a regulator and not leave any ambiguity in demanding that research be ethically conducted. We argue that inclusion of sections 39 and 40 in the Act are meant to reinforce the moral requirements that are already standard practice. 7.0 Conclusion There is a general agreement among the respondents that the Act has made a difference is the national effort to control the spread of HIV. Those involved in the implementation were more likely to be optimistic. Actions that have so far been taken by the Government are justifiable and logical. There is a widespread consensus that commitment is high towards the prevention of the disease and that most of the activities so far accomplished are within the morally acceptable limits. The cases that have been launched in the courts are procedural and do not present challenges to the underlying moral foundations of the law. The current problems with institutions and responsibilities are temporary and will be resolved in time. The Act remains an important addition to national efforts to control HIV and AIDS. Ethical debates about any of its clauses cover a wide spectrum from the purely academic to practical and do not hinder it from making useful contributions. 15 Elizabeth A. Oduwo; Rethinking State Participation in HIV Vaccine Trials; Proceedings of the International Conference on Bioethics; Egerton University/UNESCO 2010; PP35 17