mweaverling RHSC Conference brings forth joint statement on oxytocin management and guiding principles on QA

On March 25-28, 2019, PFSCM attended the 19th General Membership Meeting of the Reproductive Health Supplies Coalition (#RHSupplies2019) in Katmandu, Nepal, from which two important pieces of news emerged.

Firstly, WHO, UNICEF, and UNFPA issued a joint statement on “Appropriate Storage and Management of Oxytocin — a Key Commodity for Maternal Health.”

Oxytocin is essential to the prevention and treatment of postpartum hemorrhage, as well as other indications. Managing the oxytocin supply chain — from procurement to cold chain management to clear and consistent product labeling — is critical to ensuring that the medicine is effective when it reaches women.

According to the statement, “Several studies confirm that oxytocin currently circulating in many low- and middle-income countries (LMICs) frequently fails to meet acceptable quality standards. Like vaccines, when oxytocin is not of sufficient quality or when it is not managed in cold chain, the medicine will rapidly degrade and become ineffective.”

WHO, UNICEF, and UNFPA strongly urge the following three actions to ensure effective management of and access to good quality oxytocin:

  1. Ensure that oxytocin is managed in a cold chain of 2-8 °C (35-46 °F) for distribution and storage.
  2. Procure oxytocin that meets the quality requirements established by WHO or a regulatory authority recognized by WHO.
  3. Label oxytocin to clearly indicate storage and transport requirements at 2-8 °C (35-46 °F).

Secondly, the Interagency Supply Chain Group (ISG) — established in 2014 to provide more effective support to country efforts to ensure sustainable access to high-quality essential health commodities — presented its final guidance on the “Guiding Principles for Donors Regarding Quality Assurance of Essential Medicines and Other Health Care Commodities.”

“Donors realize that a disease cannot be treated with a poor-quality product and should not be treated with a product whose quality is uncertain,” the guidance states. “Any amount of poor-quality medicine is unacceptable because it increases morbidity and mortality, jeopardizes the credibility of health services and programs, and in the case of antimicrobials contributes to the development of antimicrobial resistance. In addition, one cannot extrapolate the clinical trial experience (in which quality assured products are used) to the larger patient experience if non-quality assured products are used.”

The ISG sets out six agreed guiding principles that provide the framework to help assure the quality of finished pharmaceutical products that are procured with donor funds.

Read the guidance document here.

The ISG comprises 15 global agencies that support supply chain efforts across all disease areas: the Bill and Melinda Gates Foundation, DFID, Global Affairs Canada, the Global Drug Facility, KfW, the Global Fund, Gavi, NORAD, UNDP, UNFPA, UNICEF, USAID, the World Bank, the World Food Programme, and the WHO.

For more information on outcomes of the RHSC Conference, please contact Marcel Hendriks, PFSCM’s Strategic Advisor, Procurement, at mhendriks@pfscm.org.


Chris Warren Non-tarrif barriers: why do they exist and how does PFSCM navigate this environment

Non-tariff barriers are non-tax measures encountered during the importation of commodities. These are frequently encountered by the Partnership for Supply Chain Management (PFSCM) during importation processes.

Some of these contribute little to delays as their overall management is commonplace, routine and relatively straightforward. Other non-tariff measures are less routine, difficult to address and, if not innovatively and precisely managed, can have a tremendous impact on the amount of time it takes to clear commodities.

Non-tariff barriers always serve some purpose. For example, they support rules and regulations that ensure imported items correspond to national standards to protect the well-being of citizens.  Sometimes their purpose may not be as readily apparent as this, and the layers of complexity impeding the import process can seem not only perplexing, but also counterproductive.

The presence of non-tariff barriers can also be frustrating to donors and implementing partners who are contributing to addressing the health needs of countries and would prefer to see the importation process sped up accordingly.  However, as complex and time consuming as it might be, non-tariff barriers are considered to be part of the procurement process and subsequently factored into lead times when they are known. The reasons for its existence can be divided into three categories.

Protecting domestic markets

National government authorities can set restrictions on importation for specific products in order to support established local producers or protect infant industries. When there is an established domestic health commodity industry supplying to the public sector, those industries may raise concerns that imported goods destabilize their markets. Non-tariff barriers may exist to support this perspective.

Protecting consumers

National health standards for determining the safety and effectiveness of health commodities are often established based on evaluations specific to an individual country’s need. Though these may be different than those determined by donors or the manufacturer, they may still be completely valid. The basis for these differences may be various health needs that result from factors such as climate, geography, life expectancy, and disease patterns. Whatever the difference may be, these standards generally result in legislated rules and regulations to protect citizenry from the risks associated with poor quality imports, such as could be experienced with expired, fake, substandard or unregistered products.

Exercising sovereignty

Non-tariff barriers can also be a punitive response directed towards exporting countries that have implemented their own non-tariff barriers to imports from the recipient country. They may also be put in place as a response to disagreements in foreign policy objectives. Sometimes this kind of non-tariff barrier has nothing to do with the product being imported but rather with how it is imported, such as with airlines or trucking companies that are not nationally registered

Examples of non-tariff barriers
  • Pre-inspection
  • Import licenses and/or permits
  • Automatic demurrage
  • Assorted handling fees
  • Packing, language and marking requirements
  • Trade documents
  • Translation services
  • Import deposits
  • Administrative feeds
  • Airline non-objections fees

The added value of PFSCM

PFSCM’s broad awareness of multiple iterations of importation processes, and cognizance of the fact that these can, and do frequently change, enables us to work with vendors and recipients to prepare documents before commodities are shipped, anticipate where new challenges may arise, and compress delivery delays or avoid them altogether.

System strengthening is also something that PFSCM does in this area. Through collecting and documenting the evidence of the impact of non-tariff barriers on behalf of public health programs, we enable the programs to advocate for national-level policy changes that will subsequently improve their supply chains. This could be something relatively straightforward as advocating for a distinction to be made between humanitarian shipments of health commodities and commercial shipments, or raising the awareness of public officials to the human cost and health impact of inefficient port and customs management.

PFSCM also supports recipients to increase their understanding of their role in the importation process to ensure they have the capacity to handle the shipments. PFSCM works with recipient’s staff to determine the specific customs procedures and documentation necessary to bring the shipment into their country.

On occasion we also work with the recipient to draft documents in the country’s official language in order to speed up the customs clearance process.

PFSCM’s experience with a wide supplier base further enables us to consult with suppliers to learn of their experiences as they are often familiar with the importing procedures for a number of countries.

Complementing this is PFSCM’s retention of experienced freight forwarders and logistics services providers who are familiar with the requirements for the importation of health care commodities on a country by country basis

Intervening in the importation of health care commodities, particularly in situations with multiple non-tariff barriers, is not a simple process, especially if relationships between staff from different ministries do not exist.

Further, Ministry of Health programs are often not enabled with the staff or the administrative authority to intervene with other government ministries such as ministries of finance, customs, transportation or pharmacy regulatory authorities.

PFSCM takes pride in aiding in bridging the experience gap between importation authorities and health program implementers to the point where the ability of the host government to manage importation is strengthened, while the needs of public health programs are simultaneously supported.

 

Non-tariff barriers always serve some purpose such as protecting consumers, protecting domestic markets or exercising sovereignty.