Part IV: The Role of the RBM Partnership
4. Policy and Regulatory
Policy and regulatory processes are vital early steps in rolling out safe and effective new products and establishing best practice approaches to malaria prevention and management. Policy and regulatory bodies and processes are essential at both the international and country level.
WHO is responsible for setting many technical standards and policy guidelines. WHO provides international regulatory standards for Good Manufacturing Practice (GMP), as well as systems to evaluate quality of medicines (WHO pre-qualification and efficacy and safety of pesticides: WHOPES). WHO sets international guidelines for treatment and interventions, such as the inclusion of new products in WHO treatment guidelines and on the WHO Essential Drugs List.
Ideally, national regulatory and policy decisions are in line with such international guidelines. National regulatory bodies register products, ensure quality assurance and enforce mechanisms for quality control of commodities. National policy processes establish and update national treatment guidelines and drug lists. National health authorities ensure that policies are adopted and implemented throughout the country.
Regulatory decisions and policy making rely on having good information on quality, safety and effectiveness of new products and interventions. Therefore, Phase IV clinical trials, drug resistance surveillance, pharmacovigilance and ongoing operational research activities are critical inputs for successful international and national policy and regulatory processes.
Key Challenges
Today, a number of policy and regulatory challenges affect interventions and procedures needed to combat malaria. These can be grouped into two categories:
- The upstream development and generation of regulatory decisions and policies; and
- The downstream use of regulatory recommendations and policies to control the quality of interventions and to adopt and enforce existing policies.
Upstream: regulatory decisions and policy making. There are a number of challenges and issues around the development and generation of regulatory decisions and policies, including:
- International Regulatory. Not all products undergo full review by stringent regulatory authorities, e.g. ACTs. This increases the importance of the WHO technical review processes undertaken for drugs (pre-qualification), for RDTs and for insecticides and nets. Both of these processes have been criticized in the past few years for a lack of transparency and for long delays. More transparent and streamlined processes at WHO are currently a high priority.
- International Policy. International policy processes can be time-consuming, but are extremely valuable to countries. WHO is the acknowledged source of technical guidelines for countries, and is widely respected for its effectiveness in disseminating technical guidelines to countries for adoption. However in some cases, there is a lack of solid data based on field experience to inform development of such technical guidelines. For example:
- For RDTs, the international mechanism for pre-qualification and quality assurance is currently being established but batch variations are making the task more difficult.
- Policies regarding community-based case management/home management of fever are unclear, and best practices for scaling up are
- Policies on the management of severe malaria with artemisinin derivatives are necessary and pharmacovigilance to document adverse events.
- Policies regarding the treatment and management of malaria in women in their first trimester of pregnancy should be clarified.
- Policies to support countries mitigate and manage the risk of drug and insecticide resistance should be created.
- National Regulatory. Country regulation processes, for regulatory authorities to approve commodities are often complex, time-consuming and thus costly. In the case of malaria drugs and insecticides, there are often a wide variety of differing requirements for registration, which increases costs for manufacturers/distributors, and reduces incentives to register products in countries with relatively smaller markets.
- National Policy. In the absence of clear technical guidelines from WHO, country policy processes lack standardized evidence and research to support the policy-making process. This increases confusion and reduces the ability of National Malaria Control Programs to plan effectively.
Downstream: quality control, adoption and enforcement of policies. A number of challenges and issues exist after regulatory recommendations and policies are made:
- International Regulatory. Need for harmonization of quality assurance criteria across organizations and compliance with international regulatory recommendations.
- National Regulatory. National regulatory bodies have limited capacity and resources for enforcing regulations and quality control.
- National Policy. Difficulties with and lack of capacity and resources for the roll-out and implementation of policies within countries.
Priorities
Specific partners within the RBM Partnership, most importantly the World Health Organization at the international level, and national regulatory authorities and governments at the country level, have very clear mandates regarding the regulatory and policy process. However, all partners have a collective responsibility to adopt international or national regulatory and policy decisions, e.g. to support quality assurance and control.
Furthermore, the RBM Partnership should support the international and national bodies that are responsible for regulatory processes and policy-making. The RBM Partnership can provide support to strengthen regulatory and policy processes by a number of means:
- Advocate for increased attention to urgent regulatory and policy needs at both the international and national level and support activities to expedite the processes.
- Encourage operational research to create the knowledge base for regulatory decisions and policy-making.
- Promote and support enforcement, adoption and implementation of regulatory and policy processes.
Priorities for scaling up. For 2010, the immediate focus of the RBM Partnership is on advocating for some of the most critical policy and regulatory needs:
A) Advocate for enhanced regulatory processes and needed regulatory decisions. To ensure the 2010 targets of scaling up for control can be achieved there are a number of urgent regulatory needs that the RBM Partnership will strongly advocate for:
- International regulatory: The RBM Partnership will advocate for speeding up the global level registration process and improving the transparency of these processes within WHOPES, the WHO pre-qualification process, and the Global Fund purchasing guidelines. The RBM Partnership will advocate for an acceleration of the drug pre-qualification process[6]WHO informal consultation with manufacturers of artemisinin based pharmaceutical products in use for the treatment of malaria. Geneva, World Health Organization, August 2007.
Click for source with WHO. It will also support WHOPES approval process at the international level. This will involve working with manufacturers on ways that will accelerate the process and ensuring independence in evaluation. Furthermore, RBM will advocate for the importance of these international regulatory bodies and that they receive sufficient support in terms of resources.
Additionally, the RBM Partnership will advocate for interim recommendations for necessary malaria commodities and drugs that are not yet fully pre-qualified or for when there is no Stringent Regulatory Authority (SRA) authorized alternative, such as is recently being proposed for ACTs.[7]Interim report on progress against outstanding AMFm implementation challenges. Roll Back Malaria AMFm Taskforce, February 2008.
Click for source
The RBM Partnership will also support the ongoing process for international certification or recommendations regarding RDTs to support countries with quality assurance and quality control when procuring RDTs.
Lastly, the RBM Partnership will advocate for the international regulatory acceptance of Home Based Management of Fevers (HBMF) with ACTs. - National regulatory: To reduce critical time-delays during the scale-up for impact, the RBM Partnership will advocate for and encourage acceptance of international body regulatory recommendations by countries and regions (e.g. WHOPES recommendations for LLINs and pre-qualification recommendations for ACTs). RBM will also advocate for strengthened enforcement and monitoring capacity of national regulatory agencies.
The RBM Partnership will assess the potential to support the creation of regional regulatory agreements, potentially driven by regional economic groupings. These may be particularly relevant to small countries where the market is of insufficient size for suppliers to be willing to go through individual country regulatory process. Furthermore, regional regulatory bodies are a mechanism to pool expertise regarding the regulatory processes.
B) Advocate for enhanced policy processes / needed policies. To ensure the 2010 targets of scaling up for control can be achieved there are a number of urgent policy needs that the RBM Partnership will strongly advocate for. The SRNs and in-country partnerships will play an important role in these:
- International policy:
- Policies regarding appropriate use of diagnostics as well as RDT quality control at the peripheral level
- Policies regarding the treatment and management of malaria in women in their first trimester pregnancies
- Development of policies to minimize the risk of resistance spreading (i.e. policies for resistance monitoring, policies for insecticide rotation where feasible)
- National policy:
- Policies to provide guidance related to the sustained use of control measures, including the elimination of trade barriers, taxes and tariffs on malaria-related commodities
- Technical assistance to develop country and regional legislative frameworks to support development of country and regional policies
C) Advocate for enforcement and adoption of regulatory decisions and policies. To ensure the 2010 targets of scaling up for control can be achieved, there are a number of urgent policy and regulatory needs that the RBM Partnership will strongly advocate for:
- International: Promote adoption of regulatory decisions and policies by partners within the RBM Partnership
- National regulatory: Promote and support pharmacovigilance and quality control activities in countries, as well as best practices for enforcing decisions, particularly in resource-constrained environments
- National policy: Support the adoption and role out of policies within countries
Priorities for sustained control and elimination. For 2015 the policy and regulatory will continue to advocate for important improvements to the policy and regulatory process as stated in the previous section, as well as encourage operational research to create a strong knowledge base.
D) Advocate for enhanced policy processes / needed policies. Similarly, the RBM Partnership will also support and advocate for enhanced policy processes both at the international and national level:
- National policy. The RBM Partnership will support capacity development of governance structures within countries to strengthen and speed-up the national policy-making process as well as advocate for a best practice policy process within countries. The latter point includes, for example, emphasizing the importance of an early involvement of the private sector (i.e. manufacturers, wholesalers, and agencies) and local manufacturers in the national policy implementation.
Organizational Implications
Also, RBM partners need to work with the bodies with the mandate for regulatory and policy-making, to explore and support mechanisms that will accelerate the process. The RBM Partnership can facilitate this process in a couple of ways:
- Working Groups can assemble and write up Best Practices for country guidance on how to implement WHO recommendations.
- The RBM Partnership can convene key partners to discuss collaborative action to ensure effective development of policy guidelines, adoption of the policies, and implementation within countries of the recommendations. (Please see the recommendations in Part II - Chapter 4: The Malaria Research Agenda).
- The RBM Partnership can convene representatives of country regulatory agencies, the private sector (global manufacturers and local producers and distributors), donors and WHO technical representatives to discuss issues and allow for collaborative identification and resolution of problems.
This will require increased funding support. Similarly, it will be important to strengthen the bodies that provide regional support to countries with their regulatory and policy issues, such as SRNs and WHO Regional Offices.
Table IV.4: Summary of Policy and Regulatory activities
| Reference to priority | Major actions | Completed by | Coordinator (bold) / Sub-coordinatorsa |
| B | Advocate to international policy-making bodies for policies on RDTs, management of malaria in first trimester of pregnancy, community-based case management | 2010 | RBM partnership bodies |
| B | Identify and promote mechanisms to reduce the availability of artemisinin monotherapies | 2010 | WHO-GMP |
| B | Advocate to both international policy-makers and national governments for policies for resistance monitoring and containment | 2010 | WHO-GMP, Regional RBM partnersb |
| A | Strongly encourage development and adoption of international regulatory recommendations in SUFI countries to enable scaling up activities and in sustained control countries | 2010 | HWG, WHO-GMP, PSM WG, MAWG |
| C | Advocate for resources to countries for strong national government structures for policy-making and regulatory processes within countries | 2010 | RBM Secretariat, SRNs, WHO-GMP |
| B | Advocate to international policy-making bodies and funding bodies for enhanced and accelerated preparation of treatment guidelines, inclusion of malaria treatments in Essential Drugs List and pre-qualification for anti-malarials at the international level | 2010 | To be determined |
| B | Advocate to international policy-making bodies and funding bodies for enhanced and accelerated preparation of policy guidelines and recommendations by WHOPES for public health pesticides | 2010 | MAWG |
| D | Advocate to SUFI and sustained control countries for enhanced and accelerated policy processes at the national level | 2015 | MAWG, RBM Secretariat, SRNs, Regional RBM partnersb |
1 Main coordinating group / body in the RBM partnership indicated in bold. Closely linked contributors within the RBM partnership are also listed. RBM partners are not listed explicitly as their involvement occurs through the Working Group.
2 Regional RBM partners are country/regional offices of the WHO, UNICEF, World Bank, NGOs and other organizations
