The ARSO Webinar for October 14th 2020 is focused on the COVID-19 and Post-COVID-19 Africa, based on positive lessons learnt, with a call for increased manufacturing and industrialisation and increased trade among African countries within the prism of the AU Agenda 2063 and its Flagship project the Africa Continental Fee Trade Area (AfCFTA) Agreement. ARSO, with the African Export-Import Bank (Afreximbank) and the International Islamic Trade Finance Corporation (ITFC), under a new Arab-Africa Trade Bridges Program (AATB) initiative called the Harmonisation of Standards for Pharmaceutical and Medical Devicesin Africa, is focused on the harmonisation of standards for Pharmaceuticals and medicinal products for increased trade and availability in Africa.
The COVID-19 pandemic which brought the world to a halt, is considered as the most crucial global health calamity of the century and the greatest challenge that the humankind has faced since the 2nd World War, with the UN’s Framework for the Immediate Socio-Economic Response to the COVID 19 Crisis warning that “The COVID-19 pandemic is far more than a health crisis as it is affecting societies and economies at their core. The World Trade Organization (WTO) and Organization for Economic Cooperation and Development (OECD) have indicated COVID-19 pandemic as the largest threat to global economy. Indeed, never in the living memory, in recent times, has humanity faced such a challenge in medical, social and economic spheres of life that threatens lives and livelihoods on the same scale. In its April 2020 report, the African Union has reported that “Indeed, the high dependency of African economies vis-à-vis foreign economies predicts a negative economic spinoff for the continent, evaluated at an average loss of 1.5 points on economic growth for 2020 and it is unlikely that the 3.4 percent (AfDB 2020) economic growth rate for the continent, forecast last year, will be achieved because of the COVID 19 crisis”. (AUC, 2020, https://africatimes.com/2020/04/06/new-au-report-zeroes-in-on-covid-19-economic-impacts/). The decline is due to the effects on the main economic sector of tourism, air travel, Exports (commodity and the associated tumble in commodity prices), with the decline in both exports and imports projected at 35%from the level reached in 2019 (AfDB 2020).
With this in mind, and on a positive note, due to the endemic reliance on imports and the breakdowns in supply chains associated with lockdown measures, for the African continent, COVID‑19 has strengthened the case for developing intra-African regional value chains and unlocking the continent’s business potential, while focusing on the African SMEs and Africa’s Industrialisation and Manufacturing. Like the food imports, COVID 19 has also magnified Africa’s reliance on imported pharmaceuticals (both final and intermediate products) and amplified the urgency to build competitive, resilient and robust value chains in this sector, including mainstreaming the African Traditional Medicine in the National Healthcare systems and pharmaceutical policies. Karisha Banga, et al. 2020, highlights that in 2018, 82.2% and 95.9% of Africa’s imports of food items, and medicinal and pharmaceutical products, respectively, originated from outside the continent. The Eminent Persons, led by the late H.E. Kofi Anan, former UN Secretary General, on their 2014 African Economic report, highlighted that Africa spends USD 35B in food imports and projected it to be USD 100 by 2030. There has already been a positive shift from global, to, towards more regional and local supply chains, with local Manufacturers and SMEs taking the lead to manufacture the required PPEs that comply with the recommended product standards. But the long-term economic benefits, according to UNCTAD, 2018c, will arise from unleashing the potential of regional value chains in the key sector, including Agro-processing, textile and leather and the pharmaceuticals (African Traditional Medicine), to foster manufacturing, trade, industrialisation and sustainable development, and when, according to UNECA (2020, “facilitating cross-border trade through a coordinated African response to COVID-19,) the African Governments adopt and harmonize trade policies (including standardisation (TBTs) to focus on Export oriented manufacturing of Made in Africa Products and boost intra-Africa trade (trade flows) among countries, with effective support from the African Quality Infrastructures (NSBs, PAQI (ARSO)).
It is in this regard that, ARSO has partnered with the African Export-Import Bank (Afreximbank) and the International Islamic Trade Finance Corporation (ITFC) to launch a new Arab-Africa Trade Bridges Program (AATB) initiative called the Harmonisation of Standards for Pharmaceutical and Medical Devicesin Africa, aimed at promoting the quality and safety of medicines and medical devices imported or produced on the continent. The initiative, to be implemented in a phased manner over three years, has begun with the harmonisation of standards for Pharmaceuticals and medicinal products (ARSO/TC 80), and Medical devices and equipment (ARSO/TC 78). The second phase will analyse and assess existing international, regional, and national standards for their suitability in meeting the unique challenges faced by African healthcare industries before achieving the 3rd phase, which is the harmonization of the related African Standards and their adoption on the continent.
Commenting on the initiative, ITFC CEO, Eng. Hani Salem Sonbol highlighted that “From a trade development standpoint, harmonizing the standards of pharmaceutical products and medical devices in Africa is a crucial first step in facilitating local production and trade within the sector and those standards will provide a necessary baseline from which to regulate the sector more effectively, raising the quality of locally produced life-saving drugs and related products”. Mrs. Kanayo Awani, Afreximbank’ s Managing Director of the Intra-African Trade Initiative praised the initiative, noting that“At a time when the demand for quality medicines and medical devices is increasing, Africa needs to reinforce regional value chains to scale-up the supply of quality medical products and build up the continent’s resilience against pandemics like COVID-19 in the future.”ARSO’s Secretary General, Dr Hermogene Nsengimana, noted that “While on one hand COVID-19 has created social distancing as a new norm, on another hand it has brought Africa together by opening our eyes to the need for industrialisation, pointing out that Standards circulated by ARSO and other standards organisations related to face masks, and hand sanitizers have been used widely by African SMEs to develop locally made personal protective equipment thereby shedding light on the role of standards in industrialization, safety, and trade, and the project, will not only help in increasing local production but will also create trust and enable cross border trade and investment for pharmaceutical products and medical devices.”(https://www.africanews.com/2020/09/14/afreximbank-and-international-islamic-trade-finance-corporation-itfc-partner-with-arso-to-facilitate-intra-african-trade-in-pharmaceuticals-and-medical-devices-under-the-umbrella-of-the-aatb-program/)
Focusing on the African Pharmaceutical industry and the Role of Standardisation. Experiences and Challenges of ARSO Members and Strategies for Africa’s resilience and increased intra-African Trade in the post COVID 19
Moderator – ARSO – Dr. Hermogene Nsengimana, Secretary General, ARSO
Sub-Topics and Proposed Speakers:
“Scope and Standardisation needs for the African Traditional Medicine (ATM) and the role of the WHO Policy on Mainstreaming and recognition of the ATM into National Health Care systems – highlights for the Pharmaceuticals and medicinal products; and the Medical devices and equipment – ARSO Central Secretariat (Mr. Reuben Gisore).
Post COVID-19: repositioning Africa for self-reliance and resilience in the face of future Global pandemics: fast-tracking the development of “made in Africa” brands embedded in competitive regional value chains for Africa’s Key Sectors like Agro-processing and Pharmaceuticals: the AfCFTA Framework and opportunities and the role of Afreximbank – Afreximbank Official.
Reducing the Africa’s overreliance on imports and thinking Africa’s Industrialisation: positive lessons arising from the COVID-19 Pandemic with potential Home-Grown Solutions, the various Challenges, best practices, needs and opportunities. NEPAD Official
ii Experience and Challenges in the use of African Traditional Medicine – The Standardisation processes : Standards and Conformity Assessment activities : Policy and the Quality and Safety Issues – Case studies from ARSO members
Algeria
Ethiopia
Madagascar,
Nigeria.
Summary and Way Forward: ARSO – Dr. Hermogene Nsengimana, Secretary General.
Rationale for the Webinar and Background Information.
The COVID-19 pandemic which brought the world to a halt, is considered as the most crucial global health calamity of the century and the greatest challenge that the humankind has faced since the 2nd World War, with the UN’s Framework for the Immediate Socio-Economic Response to the COVID 19 Crisis warning that “The COVID-19 pandemic is far more than a health crisis as it is affecting societies and economies at their core. Indeed, never in the living memory, in recent times, has humanity faced such a challenge in medical, social and economic spheres of life that threatens the viability of all human systems and never before has health, safety and wellbeing been so vital to every aspect of our lives. COVID-19 presents unique challenges because it has no geographic center, its impact is dynamically shifting without regard to borders, and it spreads from human to human, thus threatening the very fabric of humanity that is embedded teamwork, interdependence and consultations, discussions and socialization among citizens.
The World Trade Organization (WTO) and Organization for Economic Cooperation and Development (OECD) have indicated COVID-19 pandemic as the largest threat to global economy since the financial emergency of 2008–2009, as COVID-19 has severely demobilized the global economy. In its April 2020 report, the African Union has reported that “Indeed, the high dependency of African economies vis-à-vis foreign economies predicts a negative economic spinoff for the continent, evaluated at an average loss of 1.5 points on economic growth 2020 and t it is unlikely that the 3.4 percent economic growth rate for the continent, forecast last year by the African Development Bank, will be achieved because of the COVID 19 crisis”. (AUC, 2020, https://africatimes.com/2020/04/06/new-au-report-zeroes-in-on-covid-19-economic-impacts/).
In the midst of extraordinary challenges and uncertainties, leaders are under pressure to make decisions on managing the immediate and long term impact of the pandemic and its consequences, decisions that will shape the state of the world for years to come and what might be the silver linings in the crisis and how might leaders use this moment to build a more resilient, prosperous, equitable and sustainable world, is a subject of interest (World Economic Forum 2020). On a positive note, due to the endemic reliance on imports, and the breakdowns in supply chains associated with lockdown measures, for the African continent, COVID‑19 has strengthened the case for developing intra-African regional value chains and unlocking the continent’s business potential, while focusing on the African SMEs and Africa’s Industrialisation and Manufacturing. COVID 19 has also magnified Africa’s reliance on imported pharmaceuticals (both final and intermediate products) and amplified the urgency to build competitive, resilient and robust value chains in this sector, including mainstreaming the African Traditional Medicine in the National Healthcare systems and pharmaceutical policies. Karisha Banga, et al. 2020, highlights that in 2018, 82.2% and 95.9% of Africa’s imports of food items, and medicinal and pharmaceutical products, respectively, originated from outside the continent. Not only were many of the main providers of Africa’s pharmaceuticals heavily hit by COVID‑19 (with main sources of imports being the EU-27, India and Switzerland), but many have also limited exports of medical supplies and medicines associated with the pandemic, putting many African countries in perilous positions.
In the wake of countries’ struggles to procure essential medical products to fight COVID‑19, there has already been a positive shift from global, to, towards more regional and local supply chains (with local Manufacturers and SMEs taking the lead to manufacture the required PPEs that comply with the recommended product standards) and with policy re-orientation towards self-reliance and endogenous self-sustained development, within the broad industrialization agenda of Africa (accelerating structural transformation, manufacturing, regional value chains with commensurate positive effects on the made in Africa products and product diversification) and within the prism of the African Continental Free Trade Area (AfCFTA)., . (https://trade4devnews.enhancedif.org/en/op-ed/boosting-african-regional-value-chain-development-response-covid-19-catalysing-role-afcfta). But the long-term economic benefits, according to UNCTAD, 2018c, will arise from unleashing the potential of regional value chains in the key sector, including Agro-processing and the pharmaceuticals (African Traditional Medicine), to foster manufacturing, trade, industrialisation and sustainable development.
At the continental level, UNECA and AFREXIMBANK have also partnered to support the scaling up of manufacturing of COVID‑19 medical supplies that can be produced in Africa and sent across borders. This is expected to facilitate a regional approach to developing medical value chains based on comparative advantages and economies of scale. It will also help ensure that African countries without the capacity to produce these products can access them from within the region. A recent survey jointly carried out by the Africa Trade Policy Centre (ATPC) of UNECA and International Economics Consulting Ltd. (IEC) on the impact of COVID‑19 on business and trade across Africa substantiates the ability of African firms, with effective support from the African Quality Infrastructures (NSBs), to adapt and innovate in response to COVID‑19 challenges, including global supply chain disruptions.
Therefore, as countries all over the world are making a focused effort towards the re-opening of their economies with increased surge on the demand for safe and quality Personal Preventive Equipment, the role of standardisation is being tested and manifested at the same scale, to achieve the intricate balance of saving lives and livelihoods at the same time. Like their international counterparts (ISO, ASTML, AFNOR, CEN-CENELEC, SAC-China, SIS, INTERTEK, COTECNA) the African National Bureau of Standards and Certification Bodies are taking leadership role to offer, free of charge, the necessary standards and Conformity Assessment Services (see the link https://www.arso-oran.org/standards-for-covid-19/) for the local manufacturers/SMEs. At the continental level, ARSO has partnered with the African Export-Import Bank (Afreximbank) and the International Islamic Trade Finance Corporation (ITFC) to launch a new Arab-Africa Trade Bridges Program (AATB) initiative called the Harmonisation of Standards for Pharmaceutical and Medical Devicesin Africa, aimed at promoting the quality and safety of medicines and medical devices imported or produced on the continent. The initiative, to be implemented in a phased manner over three years, has begun with the harmonisation of standards for Pharmaceuticals and medicinal products (ARSO/TC 80), and Medical devices and equipment (ARSO/TC 78). The second phase will analyse and assess existing international, regional, and national standards for their suitability in meeting the unique challenges faced by African healthcare industries before achieving the 3rd phase, which is the harmonization of the related African Standards and their adoption on the continent. Participating ARSO members have nominated Experts to expedite the process.
Commenting on the initiative, ITFCCEO, Eng. Hani Salem Sonbol highlighted that “From a trade development standpoint, harmonizing the standards of pharmaceutical products and medical devices in Africa is a crucial first step in facilitating local production and trade within the sector and those standards will provide a necessary baseline from which to regulate the sector more effectively, raising the quality of locally produced life-saving drugs and related products”. Mrs. Kanayo Awani, Afreximbank’ s Managing Director of the Intra-African Trade Initiative praised the initiative, noting that“At a time when the demand for quality medicines and medical devices is increasing, Africa needs to reinforce regional value chains to scale-up the supply of quality medical products and build up the continent’s resilience against pandemics like COVID-19 in the future.”ARSO’s Secretary General, Dr Hermogene Nsengimana, noted that “While on one hand COVID-19 has created social distancing as a new norm, on another hand it has brought Africa together by opening our eyes to the need for industrialisation, pointing out that Standards circulated by ARSO and other standards organisations related to face masks, and hand sanitizers have been used widely by African SMEs to develop locally made personal protective equipment thereby shedding light on the role of standards in industrialization, safety, and trade, and the project, will not only help in increasing local production but will also create trust and enable cross border trade and investment for pharmaceutical products and medical devices.”(https://www.africanews.com/2020/09/14/afreximbank-and-international-islamic-trade-finance-corporation-itfc-partner-with-arso-to-facilitate-intra-african-trade-in-pharmaceuticals-and-medical-devices-under-the-umbrella-of-the-aatb-program/).
The Webinar is also taking place when the International Standardisation Community is celebrating the 2020 World Standards Day on 14th October 2020 under the theme “Protecting the planet with standards”.In their Message, the IEC, ISO and ITU Presidents have highlighted that “the International standards prepared by IEC, ISO and ITU are used to help reduce the environmental impact of industrial production and processes and impact greatly on Government Policies and Health care Systems”. ARSO takes note of the initiatives by ISO to make its 20 standards freely available globally, including in Africa, (https://www.iso.org/covid19), AFNOR for the freely available AFNOR Spec – Barrier masks. The Standardisation Community appreciates ITU’s initiative on the REG4COVID platform to serve as a repository of emergency actions that the digital community around the world is taking to ensure the continued availability, accessibility and resilience of networks and resources, including virtual standardisation activities.
In all these lies the opportunities provided by the African Continental Free Trade Area (AfCFTA) agreement that serves as the leading framework for boosting intra-African trade and fast-tracking the development of “made in Africa” brands embedded in competitive and robust regional value chains and ensuring that manufacturing, agro-processing and other activities across the continent are stimulated to supply the African Single Market’ and to position Africa, more strongly in the face of future global shocks and Pandemics.
The Webinar
Objective of the Webinar
The Main objective is to offer a platform for discussions on the COVID-19 pandemic, its effects on economies, the standardisation and conformity assessment systems being put in place by ARSO members, and more so the experiences of the ARSO members in the use of the Traditional medicine to offer herbal remedies to the citizens, while also focusing on building the Africa’s resilience in the post COVID-19, through increased industrialisation, manufacturing and establishment of regional value chains and intra-African trade.
Specific Objectives
Understanding the COVID-19 effect on African Economies and how countries are responding with respect to intervention measures.
Understanding the role of Standardisation and Conformity Assessment in the fight against the COVID-19.
Understanding the standardisation activities of the ARSO Member States on providing solutions to the COVID-19.
Identifying the positive lessons arising from the COVID-19 Pandemic with respect to Africa’s Industrialisation, Manufacturing and need for increased intra-African trade, with potential Home-Grown Solutions to support pandemic resilience for Africa.
Understanding the role of ARSO and its activities towards the mitigation of COVID-19 Pandemic, including standardisation and conformity Assessment activities, and the initiatives for the Pharmaceuticals and medicinal products and Medical devices and equipment.
Understanding the role of the International Community and the International Standards in the mitigation of COVID-19 Pandemic, highlighting the theme of the 2020 World Standards Day.
Outputs of Webinar
Presentations.
Discussions and comments on the COVID-19 Pandemic, the standardisation initiatives, the use African Traditional Medicine the policy gaps, African industrialization Agenda, the intra African trade.
Report of the webinar.
Outcomes of Webinar
Enhanced understanding of the COVID-19 effect on African Economies.
Improved understanding of the role of African Traditional Medicine in mitigation of the COVID-19 and how to address the challenges associated with Quality and safety as well as policy gaps.
Increased understanding of the need for Africa’s industrialisation, Manufacturing, Regional Value Chains and the Made in Africa products for Africa’s resilience and self-reliance, in the post COVID-19 and the need for necessary policies, as per the AfCFTA Agreement.
Better understanding of the role of Standardisation (Quality Infrastructure) in the fight against COVID -19, and the need for harmonised standards and Conformity Assessment Procedures.
Better Understanding of the need to promote Competitive Africa’s SMEs and made in Africa Products and the opportunities created under the AfCFTA.
Impact
Increased productivity and Trade in Made in African Products with established Regional Value Chains, including in the Pharmaceuticals and medicinal products and Medical devices and equipment, with increased Africa’s Industrialisation, manufacturing and Intra-African Trade.
Appreciation of the Role of African Traditional Medicine in the fight Against COVID-19 and strengthened efforts towards formulation of polices for mainstreaming ATM in the National Health Care systems.
Increased development, harmonisation and adoption of Standards and Conformity Assessment procedures for the management of the COVID-19 Pandemic, including putting in place policies for the post Covid-19 to help the continent handle such pandemics in future.
Increased awareness and accessibility of the existing international (ISO), Continental (ARSO), regional (RECs), and national (NSBs) standards in meeting the unique challenges faced by African healthcare industries
Strengthened Policies and Clear frameworks for activities that prioritize the production, trade and competiveness of Made in Africa Products, including the Pharmaceuticals and medicinal products and Medical devices and equipment’s.
Right policies for the competitiveness of the African SMEs for scaled up manufacturing of made in Africa products, under the key sector for Africa’s self-reliance and resilience, including COVID‑19 medical supplies and trade across the borders through established regional (medical) value chains based on comparative advantages and economies of scale
Increased partnerships and collaborations in the implementation of the standardisation activities that address Africa’s Industrialisation, manufacturing and Intra-African Trade, including the unique challenges of the African healthcare/Pharmaceutical industries.
Mode of Presentation
Speakers may prepare brief slides of no more than 5 minutes to guide the discussions. The presentations will be projected by the ARSO Secretariat. Speakers, therefore, are kindly requested to forward their presentations early enough. The webinar will focus more on discussions. Speakers are further requested to forward detailed notes to be used for reporting purposes. The Presentations will be shared with the Participants.
ARSO, the African Organisation for Standardisation, is an Intergovernmental Organisation formed by the African Union (formerly OAU) and the United Nations Economic Commission for Africa (UNECA) in 1977 to promote Standardisation activities (harmonisation of standards and Conformity Assessment procedures) in Africa to facilitate intra-African and Global trade.
Audience
ARSO Membership, Experts and Stakeholders.
Cover Image Courtesy of Google Pictures (Market_Pharmacy_Tana_MS5179)
By: Jim Olshefsky, Director of External Relations ASTM International
Abstract: The article is intended to provide a brief introduction about ASTM International, its role in the development of standards, and promotion of the communication between ASTM International and worldwide national standards bodies, including the African Organisation for Standardisation (ARSO).
About ASTM International
ASTM International, formerly known as the American Society for Testing and Materials, is a globally recognized leader in the development and delivery of voluntary consensus standards. On June 16, 1898, seventy engineers and businessmen met in Philadelphia to form the American Section of the International Association for Testing Materials. The American Section’s first technical committee on steel initiated a series of discussions of testing and material standards for the railroad industry, where most of its members were employed. At the fifth annual meeting of the American Section in 1902, they renamed the organization the American Society for Testing Materials. In 2001, ASTM changed its name to “ASTM International” to better reflect ASTM’s support of a standards development process that incorporates consensus irrespective of national borders. Today, over 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.
ASTM’s leadership in international standards development is driven by the contributions of our members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced Information Technology (IT) infrastructure, ASTM members create the test methods, specifications, classifications, guides, and practices that support consumers, industries, and governments worldwide.
ASTM International standards are developed in accordance with the guiding principles of the World Trade Organization for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance, and transparency. ASTM International world headquarters is located in West Conshohocken, Pennsylvania, U.S.A. The organization also has offices in Belgium, Canada, China, Peru, and Washington, D.C.
Memorandum of Understanding Program
Launched in 2001, ASTM International’s Memorandum of Understanding (MoU) program promotes communication between ASTM International and national standards bodies worldwide, fostering awareness of the standardization systems of all parties involved. The purpose of the program is to increase greater worldwide participation in the ASTM standards development process and facilitate the development of national standards that will aid health, safety, environmental, and economic conditions.
ASTM has had an active role in Africa since the signing of its first MoU on the African continent with the Standards Association of Zimbabwe in 2002. Since then, ASTM has signed MoU’s with 28 other African national standards bodies as well as two regional organizations; SADC Cooperation in Standards (SADCSTAN) in 2003 and the Arab Industrial Development and Mining Organization (AIDMO) in 2019. A 2014 conversation between ASTM’s Vice President of Global Cooperation, Teresa Cendrowska, and officials from the Cameroon Agence des Normes et de la Qualité (ANOR) led to the signing of an MoU with the African Organisation for Standardisation (ARSO) in 2015.
“The MOU will strengthen the relationship between our organizations to help meet the needs of people and businesses in Africa and around the world. In addition, the MOU will aid in the development of standards for health, safety and the environment in ARSO member states,” concluded the ASTM President at the occasion of the signing of the MoU between ARSO and ASTM in 2015.
Dr. Hermogene Nsengimana, ARSO’s Secretary General, and Ms. Teresa Cendrowska, ASTM VP of Global Cooperation meet in Nairobi, Kenya at ARSO headquarters in 2018.
ARSO, formerly the African Regional Organisation for Standardisation traces its genesis to the unfolding events and the prevailing mood of the African socio-political and economic Pan-Africanism of the 1970s and the culmination of which at a Conference held at the historic and important city of Accra, Ghana in 1977. In January of that year, the African Governments under the auspices of the United Nations Economic Commission for Africa (ECA) and the Organisation of African Unity (OAU) (currently African Union (AU)) convened the Founding Conference of ARSO to consider the first Constitution of ARSO and to witness the formation of the Organisation to speed-up African Economic Integration. Today, ARSO serves as Africa’s intergovernmental standards body with the mandate of creating tools for standards development, harmonization, and implementation. Together, these systems work to enhance Africa’s internal trading capacity, increase Africa’s product and service competitiveness globally, uplift the welfare of African consumers, and serve as a standardization forum for future prospects in international trade.
The MoU signed between ASTM International and ARSO provides the opportunity for both organizations to have closer communications. It allows ASTM International’s technical resources to strengthen the relationship between the two parties to enhance their support for the needs of the ARSO Member States. ASTM International annually provides a complete subscription of its 12,000 standards to ARSO for its use in strengthening the ARSO standards program. Currently, ASTM has 116 MoU’s with national standards bodies and regional bodies worldwide, the most recent of which was an MoU signed with the Standards New Zealand in August 2020.
As reported by ARSO members in their respective annual reports to ASTM International, there are 6,632
citations to ASTM International standards from 131 ASTM technical committees. The use of ASTM standards yields many benefits and opportunities for the individual nations, the continent of Africa, and globally:
Significant cost and time reduction to deliver standards
Advances technical content and discussion
Provides a common technical, business and regulatory language
Enables the use of international standards
Limits potential for barriers to trade
Supports the UN Sustainable Development Goals
Individual MoU partner countries in Africa include Algeria, Angola, Botswana, Burundi, Cameroon, Congo, Cote d’Ivoire, Egypt, Ethiopia, Gambia, Ghana, Kenya, Malawi, Mauritius, Morocco, Mozambique, Namibia, Nigeria, Rwanda, Seychelles, Senegal, Sierra Leone, South Africa, Eswatini, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.
How ASTM Standards are Used
The information below provides some examples of how various African countries are utilizing ASTM International standards in several industry sectors.
ASTM Membership Requirements
Many professionals and students in Africa have taken advantage of the opportunity to participate as members of ASTM International, which is one of the benefits of the MoU program. Membership with ASTM International offers a wealth of opportunities, including the ability to propose modifications to the content of the standards and to make contact with some of the world’s renowned experts. ASTM membership is open to any interested party and requests for membership applications can be addressed to the author or found on the ASTM website.
ASTM Standard Development Process
The process used by ASTM International to develop standards is extremely flexible, refined over 120 years, to accommodate a diverse collection of activities. Test methods, specifications, classifications, practices, guides, and terminology are different categories of standards offered by ASTM. Areas ranging from petroleum, steel, and plastics, to homeland security, unmanned vehicles, and sustainability have all achieved standards-based solutions via ASTM’s standard development process.
ASTM receives a variety of requests for new standards development activities ranging from the development of a single standard to the formation of a new main technical committee. It’s important to note that not all requests ultimately reach fruition. As the organizational process evolves, it may be determined that the stakeholder’s interest is insufficient, other standards may exist that satisfy the particular need, or that it is premature for a consensus standards program. When a request is initially submitted, ASTM maps the scope and subject area to its existing committee population. If ASTM can find an appropriate venue, it coordinates the proposed activity with the officers of the committee and subcommittee(s) in question. If the request covers an area unrepresented within ASTM, the staff will proceed with their new organizational activity process.
All technical decisions regarding a proposed activity are made by the appropriate committee members who are technical experts from industry, government, academia, and consumers, not by the ASTM staff. Specific staff resources and activities include the following:
Staff management and administrative support for all technical committees
Professional editing
Providing templates for new standards
Web-based collaborative areas for pre-ballot standards work
Web conferencing
Electronic submittals and balloting of standards
Product and Personnel Certification Services
Interlaboratory study program
Training and symposia services
Should there be a need to revise an existing ASTM International standard, to closely meet specific needs, the first step is to contact the chair of the subcommittee with jurisdiction over the document in question to explain the rationale for that proposed change. The request will trigger the formation of a task group to develop a revision. If it is not known which subcommittee has jurisdiction, the staff manager should be contacted or the ASTM International website should be searched to locate the specific committee, subcommittee, and staff manager for all approved ASTM International standards.
There are many different roles within the ASTM standards development process including: ASTM technical committee members, technical contacts for work items, subcommittee and main committee officers, and attendees at meetings. The ASTM Regulations’ Appendix B: ASTM International Responsibilities of Membership are intended to assist members in the ASTM process in executing their respective roles and responsibilities. Because no single set of guidelines can address every possible situation, ASTM members and visitors attempt to act in a manner which is consistent with the mission of ASTM and its policies, as well as the spirit of these guidelines. Concerns regarding member responsibilities are reviewed and resolved by the appropriate officers of the technical committee.
Once approval has been received from the subcommittee to begin a revision, a new work item should be registered using the registration form in the “Members Only” area of the ASTM website. An electronic version of the ASTM standard are sent to the requester in Microsoft Word. Ballot submittal instructions are included along with the Word document. It should be noted that if any problems arise during the revision process, the staff manager of the committee will be available to resolve them.
The ballot must contain a cover letter explaining the reason for the proposed action. Examples of such reasons are the following:
Request by an organization or individual for a new standard
Substantive changes made in response to negative votes or comments on a previous ballot
Request for revisions to a standard
Any other circumstance prompting a subcommittee ballot
Subcommittee ballots are conducted by ASTM headquarters. The ballot results, negatives, and comments are included in a closing report which all subcommittee members can access via the ASTM website once the ballot is closed. Sixty percent of the official voting members must return ballots before the ballot can close. Abstaining votes are counted for the requirement. An affirmative vote of at least two-thirds of the combined affirmative and negative votes cast by the official voting members on each ballot item is required for a successful ballot of that item. Abstentions do not count in the calculation.
Negative votes received on subcommittee ballots are considered by the subcommittee that initiated the item. If substantive changes to the document are made in response to a persuasive negative vote, the item must be re-balloted. If, however, all negative votes are withdrawn or ruled not related or not persuasive, the item may go on to main committee ballot assuming all other ballot requirements are met.
The ASTM Regulations mandate that all negative votes must be considered, and proper consideration of negative votes cast throughout the ballot process demands that due process be afforded to all negative voters. Negative votes received on subcommittee ballots are considered by the subcommittee that initiated the ballot item. Negative votes received on main committee ballots are considered by the subcommittee that initiated the ballot item and, if necessary, by the main committee. The subcommittee chair report at the main meeting must report on these negative votes and the subcommittee’s consideration of them, including rationales for any action taken and vote counts on motions. At the main meeting, the committee chair must allow discussion before taking a vote on any motions to uphold the actions of the subcommittee. A hand count of official voting members must be taken on these motions. The votes are recorded, along with the reasons for the motion, in the minutes.
After a standard has successfully cleared the three levels of peer review provided by ASTM (subcommittee, main committee, and Society), it is assigned a fixed alphanumeric designation and receives an official approval date. The document is then considered to be an ASTM standard and is capable of being cited in contractual language, referenced by a code body, or mandated by a state or local government. Average development time for a new standard is approximately 18 months and eight months for a revision of a currently approved standard.
During the main committee ballot and Society Review, the ASTM editorial department works to ensure that the standard is in the correct format and is correctly tagged using Standard Generalized Markup Language (SGML).
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Proficiency Testing Programs
ASTM proficiency testing programs are statistical quality assurance programs that enable laboratories to evaluate & improve performance, as well as maintain and fulfill mandatory accreditation requirements. As a proficiency testing program participant, laboratories receive different samples (representative of the product line) for each test cycle, electronic data submittal forms, and test instructions. The laboratory performs the test they normally conduct within their own facility using the specified ASTM methods cited in the program. Upon completing the tests, each laboratory electronically submits their test data to ASTM for use in generating statistical summary reports. 70 laboratories from 15 different African countries, are already participating in 35 different programs.
Visits of International Delegates to ASTM International
In 2019, ASTM staff met with a delegation of international experts at the Bi-annual meetings of ASTM committee D02 on petroleum products, liquid fuels, and lubricants in New Orleans, LA, USA. The visit focused on learning more about the U.S. standardization system, ASTM’s standardization process, and specifically ASTM standards for petroleum products. The delegation included experts from the petroleum industry globally, some of whom were traveling to the meetings on business and others who were participating in ASTM led programs. ASTM regularly offers capacity building activities both in-person and online.
From left to right: Elton Patram, Guyana National Standards Bureau; Jaeuk Ahn, Korean Agency for Technology and Standards; Paul Ameh, Standards Organization of Nigeria; Jerome Nzuba, Kenya Bureau of Standards; Joyce Mbeyella, Colonial Pipeline Co. (originally Tanzania); Ricardo Villalva, Petro Ecuador
Opportunities for delegations or individuals to visit ASTM International are available to representatives of industry and government. These visits are for those who wish to use or better understand ASTM International standards and/or contribute to the content of the ASTM standards to reflect local market and regulatory needs. Participants can meet with technical experts in their field and develop a network of contacts. A typical program includes eight to ten participants who are technical experts within a sector or technical field. Costs are covered primarily by the participants’ sponsoring industry or government, although ASTM staff plans and executes these programs, including key site visits, for which it does not charge the participants.
ASTM and ARSO will continue to take steps to encourage and support greater African participation in ASTM standards development activities and in laboratory proficiency testing programs. Together they will pursue professional exchange programs for ARSO experts to come to ASTM International Headquarters for extended study of the ASTM International standards development process.
About the Author
Mr. Jim Olshefsky has worked at ASTM International for 22 years supporting the development and promotion of voluntary consensus standards for materials, products, systems and services. In 2007, Mr. Olshefsky assumed the role of Director of External Relations where he helps to facilitate ASTM’s international outreach within ASTM’s Global Cooperation Department. Mr. Olshefsky supports ASTM’s Memorandum of Understanding program with developing countries and his work is focused in Latin America, the Caribbean, and the Middle East. His contributions include speaking to international audiences, students, and educators to promote the use of ASTM standards worldwide and to encourage increased standards education at universities. Prior to moving to Global Cooperation, he directed ASTM’s Committee Services Department in the Technical Committee Operations Division and spent several years as a Staff Manager of various ASTM technical committees. Mr. Olshefsky has a BS degree in Business Logistics from the Pennsylvania State University.
More information on the MoU program can be found on the ASTM International Web site (www.astm.org/GLOBAL) or contact Mr. Jim Olshefsky at jolshefsky@astm.org
Jim Olshefsky, ASTM International, attending the 2018 ARSO General Assembly
The new initiative aims to harmonize African standards for pharmaceuticals and medical devices thereby enhancing intra-African trade, reducing substandard counterfeit products, and building resilient regional health systems.
(Jeddah, Cairo, Nairobi, 14 September 2020) – The African Export-Import Bank (Afreximbank) and the International Islamic Trade Finance Corporation (ITFC), have partnered with the African Organisation for Standardisation (ARSO), to launch a new Arab-Africa Trade Bridges Program (AATB) initiative called the Harmonisation of Standards for Pharmaceutical and Medical Devicesin Africa, aimed at promoting the quality and safety of medicines and medical devices imported or produced on the continent.
Harmonized product standards are critical to the implementation of the African Continental Free Trade Agreement (AfCFTA), ensuring that producers of goods on the continent comply with one shared set of minimum regulatory and customer quality requirements, in turn allowing them to supply the continental market and beyond with goods that meet those standards. The harmonisation of standards also serves to enhance the quality of African manufacturing and boost intra-African and Arab-African trade and investment – one of the AATB’s key objectives.
The initiative, which will be implemented in a phased manner over three years, begins immediately with the harmonisation of standards for pharmaceutical products and medical devices for use in the ongoing COVID-19 pandemic. The second phase will analyse and assess existing international, regional, and national standards for their suitability in meeting the unique challenges faced by African healthcare industries before achieving the 3rd phase, which is the harmonization of the related African Standards and their adoption on the continent.
Commenting on the initiative, ITFC CEO, Eng. Hani Salem Sonbol said, “From a trade development standpoint, harmonizing the standards of pharmaceutical products and medical devices in Africa is a crucial first step in facilitating local production and trade within sector. Such standards provide a necessary baseline from which to regulate the sector more effectively, raising the quality of locally produced life-saving drugs and related products, and ensuring timely access to appropriate and affordable medicines, vaccines, and other health services for those who need them most. It will also act as a catalyst for Africa to benefit from a burgeoning pharmaceutical sector, expanding trade opportunities locally and beyond borders thus creating long term sustainable socio-economic impact on the continent”.
The initiative will also serve to enhance trade and investment within Africa’s healthcare industry by boosting the manufacture of high-quality homegrown products and services – objectives laid out within the AfCFTA.
Welcoming the initiative, Mrs. Kanayo Awani, Afreximbank’s Managing Director of the Intra-African Trade Initiative said, “At a time when the demand for quality medicines and medical devices is increasing, Africa needs to reinforce regional value chains to scale-up the supply of quality medical products. This would also contribute to building the continent’s resilience against pandemics like COVID-19 in the future. Furthermore, leveraging on the African Continental Free Trade Agreement, this joint initiative will also facilitate increased intra-African trade in pharmaceuticals and medical consumables.”
As part of a COVID-19 response, the harmonization of standards will facilitate the development of equivalent technical regulations among African countries. Therefore, distribution of medical supplies and equipment from one country to another can be fast-tracked.
A long-term outcome of the initiative will be the emergence of regional supply chains for pharmaceutical and medical devices, which will foster an ecosystem of innovation, local production and the development of medical products for diseases that are currently neglected.
Commenting on the initiative, ARSO’s Secretary General, Dr Hermogene Nsengimana, said “While on one hand COVID-19 has created social distancing as a new norm, on another hand it has brought Africa together by opening our eyes to the need for industrialisation. Standards circulated by ARSO and other standards organisations related to face masks, and hand sanitizers have been used widely by African SMEs to develop locally made personal protective equipment thereby shedding light on the role of standards in industrialization, safety, and trade. This Initiative with Afreximbank and ITFC, will not only help in increasing local production but will also create trust and enable cross border trade and investment for pharmaceutical products and medical devices.”
The African Organisation for Standardisation (ARSO) will play a key role in the development of standardization policies, applying existing principles and procedures that are already set out in the African Standards Harmonisation Model (ASHAM). ARSO’s involvement will be supported by its Council, in addition to a Joint Advisory Group comprised of Regional Economic Communities, and a series of technical committees, which will carry out the harmonisation work with the resources provided under this grant from AFREXIMBANK and ITFC.
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About the International Islamic Trade Finance Corporation (ITFC)
The International Islamic Trade Finance Corporation (ITFC) is a member of the Islamic Development Bank (IsDB) Group. It was established with the primary objective of advancing trade among OIC member countries, which would ultimately contribute to the overarching goal of improving socioeconomic conditions of the people across the world. Since 2008, ITFC has provided more than US$51 billion to OIC member countries, making it the leading provider of trade solutions for the Member Countries’ needs. With a mission to become a catalyst for trade development for OIC Member Countries and beyond, the Corporation helps entities in Member Countries gain better access to trade finance and provides them with the necessary trade-related capacity building tools, which would enable them to successfully compete in the global market.
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About the African Export-Import Bank (Afreximbank)
The African Export-Import Bank (Afreximbank) is a Pan-African multilateral financial institution with the mandate of financing and promoting intra-and extra-African trade. Afreximbank was established in October 1993 and owned by African governments, the African Development Bank, and other African multilateral financial institutions as well as African and non-African public and private investors. The Bank was established under two constitutive documents, an Agreement signed by member states, which confers on the Bank the status of an international organization, and a Charter signed by all Shareholders, which governs its corporate structure and operations. Afreximbank deploys innovative structures to deliver financing solutions that are supporting the transformation of the structure of Africa’s trade, accelerating industrialization and intra-regional trade, thereby sustaining economic expansion in Africa. At the end of 2019, the Bank’s total assets and guarantees stood at USD$15.5 billion and its shareholders funds amounted to US$2.8 billion. Voted “African Bank of the Year” in 2019, the Bank disbursed more than US$31billion between 2016 and 2019. Afreximbank has ratings assigned by GCR (international scale) (A-), Moody’s (Baa1) and Fitch (BBB-). The Bank is headquartered in Cairo, Egypt.
About the African Organization for Standardisation (ARSO
The African Organization for Standardisation (ARSO) traces its genesis to the unfolding events and the prevailing mood of the African socio-political and economic Pan-Africanism of the 1970s, the idea of a continental standardization body had received considerable impetus from the buoyant and optimistic mood that characterized the post-independence period in most of Africa. The mood then, under the Organisation of African Unity (OAU),currently African Union, was one of pan-African solidarity and collective self-reliance born of a shared destiny with standardization viewed as a guidepost of the destiny and bedrock of African Economic Integration Agenda and a route to linking up of the fresh Africa’s economy with the rest of the world and to deliver the African Common Market for economic prosperity of the continent. ARSO was then established by OAU as intergovernmental organization, 1977 mandated to harmonize standards and conformity assessment to increase intra Africa trade and global trade. Under the AfCFTA agreement, ARSO is in charge of developing standards to be used by the State party. The standardization work is done by experts nominated by African Union’s member states who are members of ARSO, and the work is guided by the Africa Standard Harmonization Model (ASHAM).
About the Arab-Africa Trade Bridges (AATB) Program
AATB is a multi-donor, multi-country and multi-organizations program, aiming to promote and increase trade and investment flows between African and Arab member countries; provide and support trade finance and export credit insurance; and enhance existing capacity building tools relating to trade. The program specifically focuses on the key sectors of agriculture and related industries including textiles; health industry including pharmaceuticals; infrastructure and transport; and petrochemicals, construction material and technology.
