Name of Lead Author: Nthabiseng Meriam Mabokang Sekokotoana
Organization: Attorney-General's Chambers: Office of Parliamentary Counsel, Ministry of Law
Lesotho, like most countries, recognizes the need for protection of health and appreciates its obligation to ensure that access to medical services and improvement of public health is provided for all.1 It is through this recognition that Lesotho formulated a Health Policy which ensured that its citizens would get access to public health. The question however is how effective is the policy, how harmonized is it with other sectors which may influence and affect the effectiveness of its objective and how coherent is its regulatory framework in addressing challenges such inadequate innovation of successful health technologies which may be hampered by research and development, affordable national capacity to develop appropriate policy and regulatory framework.
Lesotho has further developed a regulatory framework which envisages addressing the need to protect public and ensure access to health by developing a draft Bill on Medicines and Medical Devices. Further questions arise, how coherent is this framework with other sectors of government and how complaint is it with the recognition of intellectual property rights, such as Patents as envisaged under international treaties to which Lesotho is a party to, such as the Trips Agreement 2.
Contributions made against this background are conducted from a perspective of Parliamentary Counsel (PC). PC’s core function is to translate and transform government policies into law by drafting government legislation. The author is currently charged with the responsibility of drafting the Medicines and Medical devices Bill and is also responsible for drafting intellectual property legislation in the country.
In performing this function, the author seeks to contribute by indicating how if properly engaged Parliamentary Counsels play a pivotal role in ensuring coherence among various government policies. The author thus envisages addressing how the misalignment encountered or existing between rights of inventors, human rights, law, trade rules and public health can be overcome.
A brief explanation of Parliamentary Counsels role of transforming government policies into law will be discussed in line with how it can assist in reducing incoherence in rules between rights of investors, international human rights laws, trade rules and public health objectives by outlining processes and procedures that need to be strictly followed by countries amended.Secondly, a case study of Lesotho’s current status and some of the initiatives taken will be looked at. Lastly, a conclusion will be drawn and recommendations will be made. 1. Lesotho Constitution 1993 as amended.
Countries recognize the importance of public health related innovations and inventions and the need for citizens it access to them. To attain this, countries need to develop policies and laws that establish regulatory frameworks which will effectively address the recognized objective. Various sectors are involved in such initiatives like health, law, trade, environment, human rights or agriculture, universities and science and technology departments to name just a few. As a result when formulating policies and laws it is imperative to have a well outlined coordination among these sectors to enable coherent and effective functioning. Truth be told, such coordination is difficult to realize and it creates a huge hurdle for the better functioning of government to enable it to meets its objectives. PCl can, through the skills imparted on them, be entrusted to remove such hurdles of policy incoherence.
During formulation of legislative and regulatory frameworks, which for the purpose of this contribution is earmarked as one of the important pillars of addressing challenges encountered to improve and provide access to public health and promoting research and development and innovation for related health technologies, PC is mandated to ensure that there is a well coordinated and thoroughly thought out policy in place.
2. Trade Related Aspects of Intellectual Property Rights Agreement1994.
Parliamentary counsels’ fundamental role is to ensure that government policies are transformed into law and are given legal effect so as to enable successful implementation of the legislation. In order to effectively perform this function, it is worth to note that Parliamentary counsel possess the unique drafting and legal skills which enable extensive experience in offering advice during policy formulation. One of the most important skills PC possesses relevant for the purposes of addresses incoherences in policies is that of having the ability to ensure compatibility with other legislation. This means that PC interacts with various stakeholders and deals with a wide range of issues and areas of national importance. PC then is one of the key people who can identify relevant stakeholders both who are in the health sector and those who are either directly or indirectly affected or related to health issues such as trade, agriculture, environment, law and human rights to name but just a few.
On this background, PC highly appreciates the need for thorough consultations during policy formulation because she knows that through such consultations, clarity is attained and conflicts avoided. Suggestions are made that maybe to overcome this hurdle, governments should provide time. A requirement mostly overlooked because political objectives often come with flag tags of “urgent” formulations of policies which are either incomplete, “copy and pasted” from other jurisdictions or are non-existent and yet proposals are put forward for developing legal or regulatory frameworks. The resulting effect is always unharmonised policies which makes it difficult for implementation.
Such consultations if properly conducted, they can avoid incoherences because it is at this stage where thorough understanding of and the extensive analysis of the policy proposal is dealt with. PC, with the expertise and specialist skills acquired through training is able to advice on the best approach to be chosen which would eventually give the policies the legal effect it envisages. It is also at this juncture that the author believes countries should deeply consider utilizing the Regulatory Impact Assessment (RIA) tool. Lesotho is in the process of considering requesting this tool to be a compulsory requisite from ministries to prove that during policy formulation they conducted the RIA. This tool assists in governments deciding which option is best suited to address the problem faced and ensures efficiency and practicability in implementation because in most cases wrong approaches for problems are sought out. For instance in a case of access to medicine, when we discuss the issues of affordability, one would argue that is pricing and patent a case protection the significant problem that requires to be solved and is legislation the appropriate solution or is the problem more of careless administration of medicines where incorrect dosages are given may lead to resistance of those medicines? So would the problem not be that of health services provider’s attitudes or ignorance which now would be more of in-depth training of such which may not necessarily be addressed through regulation? RIA therefore helps identify the actual problem that needs to be attended and the correct solution to the actual problem. Maybe another example to illustrate this point would be the case of medicines containers where it was believed that children were dying due to the easy caps attached to medicine bottles. To address this problem a policy was put in place to obligate manufactures to produce caps which would be hard for children to open and came up with the press-push and twist caps. A child upon realizing that she could not open the bottle started out of frustration banging the bottle and to her satisfaction the bottle opened and she gladly took her dosage of the medicine. So in this scenario, it is realized that the real problem here was not the caps but accessibility of medicines where parent left them within the visibility and reach of children. The real solution to this problem was therefore a matter of public outreach than It is therefore imperative to involve PC as a strategy to avoid policy incoherences because PC is, “ an architect of social structures, an expert in the design of frameworks of collaboration of all kinds of purposes ,a specialist in the high art of speaking to the future, knowing when and how to try and bind it and when not to try at all. The difference between a mechanic and a legal draftsman turns largely on an awareness of this point ”3.
Some of the mechanisms and initiatives made by the author’s jurisdiction in an effort to minimize and try to overcome hurdles of incoherent policies are amongst others the attendance of an African Regional Meeting held in Ethiopia on Promoting Policy Coherence for Health Technologies-Access and Innovation Consultative Forum with particular emphasis on policy coherence and coordination within the national, regional and international level for laws and policymaking affecting access to and innovation of health. In this meeting a presenter from the EU5 shared with us the Pharmaceutical manufacturing Plan for Africa which recognized the need for local production on pharmaceutical products throughout Africa and also that the “production of quality medicines and the development of an international GMP compliant industry in Africa is possible, desirable and eminently doable”. This plan further recognized that countries in the region should align themselves with the African Medicines Regulatory Harmonization Program so as to ensure quality, safety and efficacy and most importantly, create harmonization of medicines frameworks. The author is proud to mention that Lesotho has aligne herself wi.th the framework during the development of the Lesotho Medicines and Medical Devise Bill, 2016. Furthermore TRIPs flexibilities were also discussed and Lesotho regards such opportunities as highly useful in improving access to health technologies and is in the process of incorporating such flexibilities for the benefit of its nation.
Another strategy that was discussed at the meeting which the author believes is worth sharing is the the Zambian case study, and which Lesotho also seeks to adopt and is the preliminary stages, where Zambia established a national Multi-Stakeholder Working Group and a Ministerial Working Group. This strategy is seen as an effort that would also assist with improving policy coherence. Lesotho has since C established the Inter-Ministerial Committee which is currently developing its terms of reference. Its is hoped to be a success story which will help improve and promote access to health while at the same time complying with, recognizing and protecting international obligations, the right to health and intellectual property rights.
Lesotho through a private mobile network company, Vodacom Lesotho, in collaboration with the Ministry of Health, has initiated a project known as Mojo. The main objective of this project is to identify and provide treatment for children between the ages of 0-14 who are infected with HIV. To achieve this objective, the project uses a mobile application given to nurses across the country to enable them to capture data and link the patient’s data to health care such as village health workers so as to enable patients to get referrals to appropriate facilities as and when need arises. The applications are technology based and are said to assist with monitoring and managing patients data which will enable access to the required treatment because accurate patient data will have been captured. Through this strategy, mobile outreach programs were made where they facilitate mobile money services that enable and access health. Furthermore through the Mojo project, patients are given transport vouchers to assist them to travel to clinics. An observation made however is patients sometimes even when they are given transport vouchers, they do not go to clinics as expected. A major observation made , which is believed may hamper access to and improve health care is lack of a competent management health system. It is believed this is the area of concern which needs major creativity in terms of how it will be addressed because evidence has indicated that even where services are free, access is still a challenge. Maybe extensive training should be provided and more payment given to the nurses and other health providers among other solutions. Furthermore, it has been suggested that the public needs fully intergrated health care because it is more patient focus than being disease based.
Another initiated strategy which may address the challenges of inadequate research and development and innovation is an establishment of a centralized focal point for science and technology for all those relevant ministries and stakeholders. In Lesotho, the Department of Science and Technology in in the process f facilitating enactment of the Science and Technology Bill, 2016 into law which seek to establish a Science and Technology Commission as such a focal point and coordinating body on science and technology issues for all sectors. Within the proposed law, there is a provision which also establishes an innovation fund whose objective is to encourage people to innovate by assisting with funding potential innovators. The potential innovators will submit proposals to the Commission for assessment and determine which proposals have the potential to solve problems encountered by society and then award small grants to the potential innovator to pursue further research and development because funding is seen as a major hindrance for promoting research and development. The proposed law further establishes an Appropriate Technology Centre which serves more as an implementation where new technologies are tested and validations made. This would also seek to address the challenge of lack of resources, especially laboratories to enable local innovation to take place. A proposal is also encouraged of establishing a Cabinet Committee on Science and Technology which would ensure coherence at the level of the executive which would facilitate acknowledgement and promotion of access to services like health through promoting, research and development and innovation.
Another challenge the department felt hinders innovation is the fact most institutes seem to be more teaching based than research based. For instance, our national University does offer any PHD programs at institutes because it seems to be diverted elsewhere to other commitments. It is also indicated that initiatives such as the Horizon 2020 which through it the department was able to send a scientist from Lesotho to South Africa to take samples of traditional medicines to be tested and validated for the treatment other HIV//AIDS infections. Those samples were also taken to Switzerland for further analysis and the results are said to be promising because there has been a certain percentage of the samples which have shown a direct impact on the actual virus than just improving the immune system. Further test and analysis of the traditional medicine are yet to follow. This occurrence is very interesting because it also raises issues of intellectual property law of the growing concern of protection of traditional knowledge. Another initiative known as SANBIO is seen as another strategy to be utilized for promotion of research and development in that it encourages proposals to be submitted for assistance in funding and facilitating further research. As a result health Committee was established which meets monthly to discuss health issues related to innovation. The committee has formulated a spreadsheet which they say is sent to institutes and requests them to submit lists of areas of interest.
Establishment of a central coordinating body was a sentiment shared by a lecture from one institute . He believes such a strategy would be the most viable solution to address the challenge of inadequate research and development because he also says funding and lack of resources greatly hampers learning and of students to research because teaching is concentrated more on theory than practical’s. The lecturer further indicated that as an effort to enhance research and development at the institute there is a proposed development plan that the institute envisages to utilize. He also proposed that maybe if the institute could merge engineering programs offered at the institute which are electrical and mechanical tand detailed.
Students consulted also felt lack of resource hampers their learning and innovation capabilities . The student indicated that they feel less motivated because of a seemingly ignorance of their innovation which leaves their efforts made during their learning years unacknowledged. They suggested that maybe if after completion of their studies they could placed at incubation centres like the one currently established by the mobile company Vodacom Lesotho known as Innovation Park. This they said hinders them from engaging in further research. The further reiterated that because of lack of resources they fund their own projects and as a result, even if they have a certain idea and it appears to be costly, they feel it is better to abandon their preferred idea and opt instead for something less costly for fear that if they pursue their preferred idea they will fail. So clearly students feel less encouraged to research and invent innovations that rare more useful for the benefit of the nation and this says focus for students are more survival based than passion and talent based. An worrying perception which requires urgent attention.
If a country does not have a healthy productive nation, then the economy will wither too. Policy coherence and a well coordinated legal and regulatory framework needs to be put in place to ensure that they harmonized by having a committed nation and leadership which seek to address reasons anticipated are contributing to the existence of challenges identified.
Although Parliamentary Counsel does not initiate policy, it is highly recommended that it is imperative to involve the because of the specialist expertise they posses which would extensively assist in ensuring policy coherence due to their vast knowledge of existing laws. As a result, they interact with various sectors and are therefore have the potential of being able to identify relevant stakeholders who would be affected by health issues raised. The need for adoption of pharmaceutical manufacturing plans and harmonization regulatory frameworks cannot be emphasized enough. Furthermore the Zambian case study should be followed of establishing a National Health Multi Stakeholders Working Group and lastly, the author thinks the use of mobile application to improve access is a phenomenal strategy to be adopted.
Bibliography and References
1. Constitution of Lesotho 1993 as amended.
2. Dee Harlow, Head of Lesotho Pediatric HIV Program, Vodacom Foundation, Maseru, Lesotho.
3. Janet Byaruhanga,AUC:The African Union Pharmaceutical Manufacturing Strategies for initiating and sustaining local production capacity in Africa.
4.Rasekeiti Mohlomi, Keneuoe Morake, Ramabusa Thabo Nkoho Rethabile all who are 6th Semester final year Electrical Engineering Students.
5.Tladi Manosa, Lecturer of science and maths at Lerotholi Polytechnic Institute, Maseru, Lesotho. . Trade Related Aspects of Intellectual Property Rights Agreement1994.
6. Ts’epo Ntho, Senior Research Officer, Department of Science and Technology Lesotho.
7. V.C.R.A.C.CRABBE:Legislative Drafting 1st Ed P21,1993 London.