Reproductive health supplies: a question of availability, quality and affordability.

Posted by Maria Codina on January 29, 2018 at 11:10 am



Reproductive health supplies: a question of availability, quality and affordability. Be-cause health Seminar on access to quality medicines and supplies for sexual reproductive health and rights – SRHR, Wednesday 8th Nov., Brussels

Insights and recommendations based on notes from the Seminar and presentations. Presentations and recording of the session are available in a dedicated space on the Be-cause health webpage.

 

Insights

Achieving Universal Health Coverage includes providing access to quality reproductive health supplies to all those in need, and it implies financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.

Quality of Reproductive health supplies

✓ The globalization of pharmaceutical production has not been accompanied by the strengthening and harmonization of the regulatory systems worldwide, and the global market is characterized by a situation of multiple standards, with patients in low- and middle-income countries especially at the risk of receiving poor-quality medicines1. Medical products for Reproductive Health (RH) products are not an exception to this;

✓ The WHO Prequalification Programme, established in 2001, to guide UN agencies and other international organisations with respect to the quality of antiretroviral medicines for supply to low-income countries, now covers a wider range of therapeutic fields, including reproductive health2. Nonetheless, there is need of more pre-qualified products for reproductive health. For instance, to date there are no pre-qualified sources of Benzathine penicillin, despite its key-importance in prevention and treatment of syphilis;

✓ The WHO Survey of the quality of medicines identified by the UN Commission on life saving commodities for women and children, published in 2015, showed that 23% of samples3 failed one or more tests when tested “against pharmacopoeial specifications rather than the manufacturers’ specifications”. The highest proportion of non-compliance found for oxytocin injection (64%), and relatively high failure rates were recorded for gentamicin, ampicillin and dexamethasone phosphate injections. The authors note that “more intensive cooperation and exchange of information among regulators would help to eliminate poor quality medicines. Regulatory cooperation, harmonization of regulatory requirements and procedures can also help to improve regulatory efficiency and incentivize manufacturers to register more UNCoLSC-relevant medicines in the respective countries”. The full report is available here.

Availability of Reproductive health supplies

  • Supply planning and monitoring is critical to improve access to medical products for family planningto all those in need in low- and middle-income countries;
  • Shortages of reproductive health supplies (stock-outs) continues to be a concern. UNFPA estimatesthat in the 46 FP2020 focus countries in which the UNFPA Supplies programme operates, on average, only 50 per cent of service delivery points have three or more lifesaving maternal health medicines available. The probability of stock-outs was higher at primary level than at secondary and tertiary level4;
  • The pilot experience by MSD for Mothers in Senegal suggests that moving from a pull supply chain to an ‘informed push chain’, that integrates private sector logistics providers into public health supply chains and delivers commodities directly to the peripheral health facilities, may strengthen commodity, data, and financial flows across the public health supply chain, and help solving stock- out problems
  • There is a need for increased national capacity building, in particular in case of transition from externally funded programmes to services and regulation funded with domestic resources;
  • There is a need for accurate and public information on the global needs. Generic manufacturers need this information as a “market incentive”: without accurate figures of the possible market size, it is unlikely that they will invest in quality-assured products for family planning for the market of low- and middle-income countries.

Affordability

  • Prices were reduced for 94% of contraceptives procured in 2016 by the UNFPA Supplies program. UNFPA Supplies contributed over 40% of all donated health commodities and reduced prices via long-term agreements, volume guarantee mechanisms5;
  • Transition from international development assistance to a reliance on national (public) financial resources needs to avoid increased out-of-pocket payments (OOPs) by the population – users of health services. Reproductive health needs to be affordable to all6 without carrying the risk of catastrophic expenditure;
  • Affordability can be enhanced by risk pooling (through social security systems), as well as including a benefit margin for distributers in the reimbursement of costs can reduce out-of-pocket payments. In addition, third party payments of pharmaceuticals after delivery of products can reduce direct payment and avoid out-of-pocket payment.

Recommendations

The Belgian government incl. DGD, Ministry of Foreign Affairs should

  • Continue to champion universal access to quality-assured products for SRH at public fora, andadd/include a call for a sustained/increased focus on quality of Reproductive Health products, including

    possible prioritization of products for RH in pre-qualification;

  • Based on continued Belgian core-funding to WHO, inquire publicly / plead within WHO governance(Executive Board, …) for a sustained budget allocation for the pre-qualification team, including for

    reproductive health products;

  • Continue to facilitate equal partnership between public and private actors, with the aim of benefitingand sharing of knowledge & skills transfer; for example in setting up high performance supply chains,

    and/or in providing technology transfer to local manufacturers;

  • Facilitate / foster strengthening of national regulatory authorities in partner countries.Belgian implementing development actors, NGOs and researches, should
  • Ensure that products they supply for RH are quality-assured (ref. to the Quality Engagement) and whenpossible support national procurement centres to strengthen their supply and quality systems;
  • Timely report to the national regulatory authorities and to the WHO Alert System any cases ofsubstandard/falsified medicines;
  • As research members take advantage of the Be-cause health platform to jointly generate and analysereliable data on their needs and consumption of products for RH. These could be regularly communicated to the WHO PQ team to suggest priorities, and published in the international press to foster advocacy;
  • Continue to invest in research on quality of medicines, by defining the priority research questions together with concerned counterparts (e.g. WHO PQ Team).

International Development Actors / Agencies should

  • Ensure quality assurance of developed and marketed pharmaceutical products, set-up monitoringsystems, and actively fight substandard and falsified medicines in collaboration with public authorities;
  • Avoid (indirectly) weakening the National Procurement Centres by setting up parallel procurementsystems for medical products; strengthen where possible capacity building of (national/local) regulatory

    authorities and national procurement centre(s);

  • Invest in ‘information sharing systems’; Invest in joint WHO – country monitoring systems; improvedata visibility; Improve ‘visibility’ by tracking the quality in country of RH Supplies procured or managed

    by International agencies such as UNFPA, UNICEF, GFATM;

  • Maintain efforts to guarantee access and affordability of RH Supplies by avoiding out-of-pocketpayments by users; keep the equal access in mind when addressing the need to develop (local) market

    share to tackle a commodity gap;

  • Assist national authorities to strengthen local production and control of medical products.National (Regulatory) Authorities should
  • Strengthen regulatory supervision on products for RH. For instance, ensure the appropriate choice ofthe pharmacopoeial specifications, ensure an adequate check on bio-equivalence studies, stability

    studies, related substances (impurities), etc.;

  • Coordinate demand aggregation, establish/share market information and market controls.
  • Align national and partner organisations’ procurement policies;
  • Improve logistics management information systems (LMIS).

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