Concept Foundation is established
Concept Foundation was initially established and supported by the World Health Organization (WHO). Under a license agreement with the WHO Special Programme of Research, Development, and Research Training in Human Reproduction (WHO/HRP), Concept Foundation was provided with clinical trial data generated by HRP and preclinical data from the Upjohn Company, and tasked with identifying, licensing and supporting manufacturers of generic hormonal contraceptives to meet international Good Manufacturing Practice (GMP) and subsequently introduce and market a once-a-month injectable, Cyclofem® (medroxyprogesterone acetate + estradiol cypionate), in lower- and middle-income countries (LMICs).
Concept continues to work in reproductive health under a general collaborative agreement with WHO/HRP, which has allowed it to translate the research activities of WHO into quality assured, affordable products for people in low and middle income countries around the world.
As such, Concept manages intellectual property developed through public funded research, as well as the design and implementation of access to medicines (ATM) programmes for hormonal contraceptives and maternal health products that meet the reproductive health needs of people in these countries.
Cyclofem® becomes available in 2 countries
Cyclofem® is first made available in April in Indonesia, then in Mexico. It further went on to be made available in Thailand, Hong Kong, and throughout Latin America.
First dedicated emergency contraceptive product
As a follow-up to an agreement between the WHO and Gideon Richter (Hungary), Concept starts work to introduce the first dedicated emergency contraceptive product, Postinor-2®, into low- and middle-income country markets.
Upjohn licenses Cyclofem® from Concept
Upjohn licenses Cyclofem® from Concept Foundation, and continues to undertake the trials necessary for USFDA, under the name Lunelle®.
Cyclofem® is registered with USFDA
Upjohn licenses Cyclofem® with the USFDA under the name Lunelle®. The product is very successful in the US, and by 3 years later it was estimated that 650,000 women there had used the product. At this point Pfizer, which had just taken over Pharmacia and Upjohn, withdrew Lunelle® from the US market as a marketing decision, to the disappointment of American service providers and staff from Pharmacia.
Concept Foundation conducts study of manufacturers of generic RH products in LMICs (IPPF-funded)
“A study of the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countries” (published in 2007).
Study of 44 companies from 15 countries manufacturing oral and injectable hormonal contraceptives. The findings demonstrated that less than 30% of manufacturers included in the study would meet GMP requirements of WHO, PIC/S or any stringent regulatory authority (SRA) and that there was a clear need for significant technical support to ensure manufacturers could work towards meeting these standards.
Funding for development of what eventually becomes Medabon®
Concept Foundation receives funding from a large anonymous donor and DFID, under a license agreement with WHO to develop a combination product with misoprostol and mifepristone, using WHO data.
Due diligence to find a manufacturing partner willing to develop the product and take it through to country registrations and access is started.
WHO Prequalification of Medicines programme launches EOI for RH
Launch of WHO Prequalification (WHO PQ) Programme Expression Of Interest (EOI) invitation for Essential Reproductive Health (RH) Medicines.
Manufacturer found for medical abortion combined product
An agreement is reached between Concept Foundation and Sun Pharmaceutical Industries Ltd., India, to develop a new dedicated product for medical abortion and make it available in low- and middle-income countries.
Cyclofem® added to WHO Model List of Essential Medicines
The WHO adds medroxyprogesterone acetate (25mg) + estradiol cypionate (5mg) to its Model List of Essential Medicines.
Concept Foundation develops and launches Medabon®
Medabon®, a new dedicated product for medical abortion, is developed in partnership Sun Pharmaceutical Industries Ltd.
Medabon® is registered in Nepal, before being registered locally in India in 2008.
WHO PQ of RH products: need for technical assistance
Of 42 dossiers submitted to WHO PQ for RH products up to this point, 25 (60%) are rejected or cancelled due to the product not meeting required quality assurance standards, inadequate/incomplete documentation or inappropriate bioequivalence study.
Accessing Quality Assurance Supplies Initiative (AQAS) programme is launched (RHSC-funded)
In follow-up to the 2007 study, this programme was designed to identify manufacturers of generic hormonal contraceptives that are potentially capable and willing to obtain WHO prequalification for one or more of their RH products in their portfolio. Concept Foundation provided technical assistance to 12 manufacturers of generic RH products.
Gap analyses were conducted for each company to identify actions, resources and time required to meet WHO PQ requirements.
AQAS programme was the predecessor to the QuRHM programme
Meeting in Kampala
- Concept Foundation holds plenary on why quality matters, to increase awareness. Presentation of AQAS findings.
- DFID invites Concept Foundation to develop a concept proposal.
- Small working group is put together to develop a strategy paper, including Concept Foundation, UNFPA, WHO PQP, and the Global Fund.
Medabon® country registrations
Medabon® is registered in Zambia.
Concept Foundation embarks on major introductory strategy across numerous low- and middle-income countries. The results of these efforts and further country registrations can be viewed on our Access to Safe Medical Abortion programme page.
Quality of Reproductive Health Medicines (QuRHM) Programme (DFID – funded)
Three-year programme designed to stimulate emergence of a vigorous market for quality-assured RH products by working with manufacturers of generic RH products to achieve WHO Prequalification.
Products included in the QuRHM programme: oral hormonal contraceptives, injectable hormonal contraceptives and maternal health products (oxytocin, misoprostol and magnesium sulphate).
The programme also focused on harmonizing procurement practices and preliminary country activities in four pilot countries to assess the RH product market and the policies and framework within which the market functions.
First WHO prequalification of a generic oral contraceptive
Prequalification of Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), pack of 21 oral contraceptive tablets manufactured by Famy Care Ltd, India.
WHO prequalification of generic Ethinylestradiol + Levonorgestrel
Prequalification of Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), pack of 21 active +7 placebo oral contraceptive tablets manufactured by Cipla Ltd, India.
Meeting on Hormonal Contraceptives and other Essential Medicines at UNFPA headquarters in New York
This meeting was a follow-up to an interagency consultation with procurers held by RHSC in Washington DC in May 2010, and focused on the harmonization and alignment of quality assurance policies and practices amongst international procurers.
This was part of the planned activities of the QuRHM programme, and was hosted by UNFPA with the support of Concept Foundation.
London Summit on Family Planning and FP2020
The London Summit on Family Planning was held in July 2012. More than 20 governments made commitments to address the policy, financing, delivery and socio-cultural barriers to women accessing contraceptive information, services and supplies. Donors pledged an additional US$2.6 billion.
The goal of reaching an additional 120 million women and girls in low- and middle-income countries by family planning services by 2020 was set and FP2020 was born.
Meetings were held that eventually lead to the formation of the Generics Manufacturers Caucus for Reproductive Health (GEMs/RH), with 4 founding members receiving help from PR firm GMMB, funded by BMGF.
Bill and Melinda Gates Foundation (BMGF) provide additional funding to the QuRHM programme to focus on DMPA
Approximately one year into the QuRHM programme, BMGF provided further funding within the QuRHM programme framework to build on the ongoing work to increase the availability of quality assured intra-muscular injectable contraceptive DMPA.
This increased effort was part of BMGF’s strategy to address the severe shortcoming of DMPA in high need countries.
Generic Manufacturers Caucus for Reproductive Health (GEMs/RH) formed
GEMs/RH comprises seven select generic manufacturers in Asia, Africa and Europe, and functions as a caucus within the RHSC.
The caucus collaborates with RHSC members to increase the availability of quality, affordable and safe reproductive health products and medicines to women, girls, and families in need.
First API and emergency contraceptive FPP are WHO prequalified under QuRHM programme
Ethinyl estradiol, manufactured by Qinhuangdao Zizhu Pharmaceutical Co Ltd in China (QZP), is prequalified by the WHO PQP under its API prequalification procedure. This is the first API prequalified for reproductive health medicines, with the technical support of Concept Foundation.
First generic emergency contraceptive product (Levonorgestrel 0.75mg) manufactured by Famycare Ltd in India is prequalified by WHO PQP.
Combined oral contraceptive is WHO prequalified
Desogestrel + ethinylestradiol formulation, manufactured by Famycare India, is prequalified by WHO PQP.
Second API for reproductive health is WHO prequalified
Levonorgestrel API, manufactured by Qinhuangdao Zizhu Pharmaceutical Co Ltd in China (QZP) is prequalified by WHO PQP.
A record 9 products are prequalified by WHO PQP in a single day
9 products are prequalified by WHO PQP in a single day, of which 4 are generic reproductive health products. This demonstrates that the WHO-PQP programme for reproductive health products is achieving results, with RHSC’s QuRHM programme, managed by Concept Foundation, playing a major role by providing technical support to manufacturers and raising awareness among international donors and procurers.
These 4 generic RH products include:
- Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), in a blister pack of 28 tablets (21 active + 7 placebo), oral contraceptives manufactured by Famy Care Ltd, India.
- Levonorgestrel (1.5mg) emergency contraceptive, manufactured by Famy Care Ltd, India.
- Noresthisterone (0.35mg) oral contraceptives, manufactured by Lupin Ltd, India.
- Desogestrel (0.15mg) + Ethinylestradiol (0.03mg) oral contraceptives, manufactured by Lupin Ltd, India.
QuRHM Programme DFID funding ends, however work continues for key products with ongoing support from BMGF.
The DFID funding for the QuRHM programme formally ended in March 2014. By this time, significant results had been achieved; a further four generic APIs and 16 generic FPPs had been WHO prequalified.
Concept recognised that the majority of the successes focused on oral contraceptives and misoprostol and that activities would need to continue to increase the number of WHO prequalified DMPA, oxytocin and magnesium sulphate.
BMGF has continued to fund Concept Foundation to work with manufacturers of generic DMPA to achieve WHO PQ as well as support on regulatory activities in parallel.
The BMGF funds are also being used to conduct a DMPA forecasting exercise and research in 10 target countries on advocacy for emerging quality assured generic products in country markets.
WHO prequalification of Ethinylestradiol + Levonorgestrel
Prequalification of Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), pack of 21 active +7 ferrous fumarate oral contraceptive tablets produced by Famy Care Ltd, India.
Two RH medicines are prequalified in the same month
Levonorgestrel (0.75mg), emergency contraceptive manufactured by Cipla Ltd, India, is prequalified by WHO PQP.
Misoprostol (0.2mg), maternal health medicine manufactured by Cipla Ltd, India, is prequalified by WHO PQP.
BMGF expands scope of funding
BMGF continues to support and fund Concept Foundation’s efforts with DMPA, and expands the scope of activities to include access to markets, reassessment of demand forecasts, and country-level research.
UNCoLSC funding for maternal health
The United Nations Commission of Life Saving Commodities (UNCoLSC) funded Concept Foundation to continue its work towards WHO PQ of selected maternal health products; misoprostol, oxytocin and magnesium sulphate as well as work with procurers at the country level to discuss and improve procurement modalities of these commodities.
The first generic oxytocin product is prequalified by WHO
Oxytocin, as a solution for infusion manufactured by JSC GRINDEKS, Latvia, is prequalified by WHO PQP. This is the first oxytocin product to be prequalified by WHO, and is an important medicine for maternal health used notably in the prevention and treatment of postpartum haemorrhage.
Another emergency contraception product is prequalified by the WHO
The WHO PQP prequalifies the emergency contraceptive, Levonorgestrel, as manufactured by Cipla Ltd in 1.5mg tablets. Cipla Ltd is located in Goa, India, and is one of the founding members of the RHSC Generic Manufacturers for Reproductive Health (GEM/RH) Caucus. This is the fourth Cipla reproductive health product to be prequalified with technical support from Concept Foundation.
WHO adds to the list of prequalified emergency contraceptives and APIs
The list of prequalified emergency contraception products expands to a total of 6 with the addition of Levonorgestrel 1.5mg tablets manufactured by Lupin Ltd. in India, thereby increasing the choice for procurers seeking to get quality emergency contraceptives into lower- and middle-income countries (LMICs).
Piramal Healthcare UK Ltd also has their 1% Misoprostol in HPMC product prequalified by the WHO, having been assisted by Concept Foundation in ensuring availability of appropriate documentation for the prequalification process.