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Prequalification as a Gateway to Global Markets &

Prequalification as a Gateway to Global Markets & Performance of WHO Prequalification of Medicines Programme CPhI China 2014 Shanghai, 26‒28 June 2014 Jacqueline Sawyer. page n  ° 2. WHO medicines prequalification | CPhI China | June 2014. Outline of this presentation:

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Prequalification as a Gateway to Global Markets &

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  1. Prequalification as a Gateway to Global Markets & Performance of WHO Prequalification of Medicines Programme CPhI China 2014 Shanghai, 26‒28 June 2014 Jacqueline Sawyer

  2. page n °2 WHO medicinesprequalification | CPhI China | June 2014 • Outline of this presentation: • Part 1: WHO prequalification as a gateway to global markets • Institutional market sizes: current and future • Quality assurance as a prerequisite • Investment needed to attain prequalification • Decision process regarding whether to submit an application for WHO evaluation • Part 2: Performance of WHO Medicines Prequalification • Customer orientation • Improvements to WHO Medicines Prequalification

  3. page n 3 WHO medicinesprequalification | CPhI China | June 2014 • Part 1

  4. page n °4 WHO medicinesprequalification | CPhI China | June 2014 • Direct and indirect value/benefits Directvalue Access to donor-sponsored markets • Improved quality of all products • Facilitated and faster regulatory approval in a range of countries (fewer inspections) • Possibility of assistance from expert consultants (GMP, dossier) • Enhanced technical and organizational capabilities and chance of succeeding with submissions to SRAs • Higher margins (non-institutional markets) • Increased market share • Contract manufacturing for local markets • Promotion of prequalified APIs • Image (internal and external) PQP Indirect value

  5. page n °5 WHO medicinesprequalification | CPhI China | June 2014 Institutional market sizes HIV / AIDS • 2012 market size antiretrovirals (ARVs): about US$ 1.5 billion • End 2012 about 10 million patients were treated with ARVs with about 29 million patients that should be treated (2013 guidelines) Malaria • Current market size antimalarials: US$ 300 million • Steady growth is expected — as older, ineffective treatments phased out and higher proportion of patients given WHO-recommended 1st-line treatment — in market for artemisinin-based combination therapies TB • Total market estimate for low- and middle-income countries: US$ 730 million • Donor market estimate: $200 million • 1st-line anti-TB medicines: US$80 mill • 2nd-line: About US$120 mill • 1st-line market should remain stable while 2nd-line market should expand with improved detection of multidrug-resistant TB Sources: UNITAID, 2014. HIV Medicines Technology and Market Landscape. CamponeschiG et al. An overview of the antiretroviral market. Current Opinion in HIV and AIDS. 2013 UNITAID, 2013. Tuberculosis Medicines Technology and Market Landscape. UNITAID, January 2012. HIV, Tuberculosis and Malaria Medicines Landscape. Progress report on emerging issues and potential opportunities to improve access.

  6. page n °6 WHO medicinesprequalification | CPhI China | June 2014 • HIV/AIDS, TB, malaria: the opportunity • Leading newer 1st-line medicines represent attractive market opportunities; prices still reasonable • Many opportunities in new formulations of leading medicines and several niche market opportunities, e.g. paediatric medicines • Price per tablet relatively stable for the leading 1st-line antimalarial • New entrant has opportunity to capture significant market share of antimalarials market • Only a few leading antimalarial products to focus on • 1st-line TB market is a stable market with stable prices • 2nd-line TB market is growing with stable prices for leading 2nd-line products

  7. page n °7 WHO medicinesprequalification | CPhI China | June 2014 • Market for reproductive health medicines • RH market seen as less competitive than e.g. ARV or anti-TB markets (i.e. higher profit margin) • Consumer focused – brand awareness • Often tenders request a (generic) branded product, especially at Ministry of Health level • Nongovernmental organizations can be loyal customers, often create their own brands • Some manufacturers create new brands for the institutional / donor market • Many manufacturers focused on RH alone • Planning by government or agencies usually poor; “family planning mindset” needed • Ramifications of poor quality are not directly life or death and governments and local procurers often do not fully appreciate the benefits of quality

  8. page n °8 WHO medicinesprequalification | CPhI China | June 2014 • Donor medical contraceptives: market growth

  9. page n °9 WHO medicinesprequalification | CPhI China | June 2014 • Quality is key to accessing institutional markets • Growingnumber of international organizations procuring or fundingprocurement of medicinesspecifythatmedicinesprocured must beapproved by stringentregulatoryauthority or WHO-prequalified, e.g.: • http://www.theglobalfund.org/en/procurement/quality/pharmaceutical/#General • http://www.unitaid.eu/en/resources/results/9-uncategorised/437-quality-assurance-for-all-unitaid-purchased-products • http://www.unfpa.org/public/home/procurement/pid/10863 • http://www.unicef.org/supply/index_41948.html • http://www.stoptb.org/gdf/drugsupply/quality_sourcing_process.asp • http://www.msf.org/msf-drugs-procurement • Even USAID (for hormonal contraceptives) • http://www.rhsupplies.org/nc/news/newsview/article/who-prequalified-hormonal-contraceptives-now-eligible-for-usaid-procurement.html

  10. page n °10 WHO medicinesprequalification | CPhI China | June 2014 • Quality also key to going beyond institutional markets

  11. page n °11 WHO medicinesprequalification | CPhI China | June 2014 • "Missing" or few products: examples • Seelist of all APIs and FPPsinvited for prequalification, and numberprequalified or currently under assessment, per product: http://apps.who.int/prequal/info_applicants/eoi/FPPs_APIs_invited.xlsx

  12. page n °12 WHO medicinesprequalification | CPhI China | June 2014 • But what investment is needed to attainPQ approval? http://apps.who.int/prequal/info_press/documents/WHO_Prequalification_WHY.pdf

  13. page n °13 WHO medicinesprequalification | CPhI China | June 2014 • Bioequivalence studies

  14. page n °14 WHO medicinesprequalification | CPhI China | June 2014 • Formulation development

  15. page n °15 WHO medicinesprequalification | CPhI China | June 2014 Investment needed to attain prequalification:Will vary depending on experience of company • Manufacturers experienced in dealing with global regulatory agencies will have fewer investments in both capital and formulation development • Manufacturers with existing dossiers will have fewer investments to make • Formulation development may be necessary and depends upon the complexity of the medicine • Companies without a WHO GMP-standard facility, will require renovations to meet GMP standards • Companies new to the pharmaceutical industry will have to make major investments in capital infrastructure

  16. page n °16 WHO medicinesprequalification | CPhI China | June 2014 • The business decisionprocess • A “PQ strategy” should not be seen in isolation but as a part of the company’s broader strategy that takes into account: • geographic portfolio • product portfolio • target markets • the type of investments required (human and financial) • company skills • market size and future demand • revenue potential • cost of applying for PQP • schedule • profit potential • degree of risk: no guarantee of securing tenders; forecasting can be challenging; expected time to approval (especially for small companies with limited SRA experience); the higher cost of producing quality products (e.g. 5‒10% greater than for non-quality-assured products). • and is supported at highest level of company.

  17. page n °17 WHO medicinesprequalification | CPhI China | June 2014 • Useful information • Current treatment recommendations: • Standard treatment guidelines for eligible medicines referenced in WHO invitations for EOI. Indications, dosage & recommended alternatives. • Competitors in the market and in the pipeline: • WHO PQP list of prequalified products & products under assessment for WHO-prequalification: http://apps.who.int/prequal/info_applicants/eoi/FPPs_APIs_invited.xlsx • Volumes procured, and at what prices: Historical pricing information can give an indication on where the markets are going. • WHO AMDS Global Price Reporting Mechanism (HIV drugs): http://apps.who.int/hiv/amds/price/hdd/ • Global Fund Price and Quality Reporting mechanism (PQR) (HIV, TB, malaria drugs): www.theglobalfund.org/en/procurement/pqr • MédecinsSans Frontières (MSF) – Untangling the Web of Antiretroviral Price Reductions. http://utw.msfaccess.org/downloads/documents • MSF –TB drugs under the microscope. http://www.msfaccess.org/content/dr-tb-drugs-under-microscope3rd-edition • Current pricing information for some products: UNICEF product catalogue with indicative prices : https://supply.unicef.org/; Global Drug Facilityproduct catalogue http://www.stoptb.org/gdf/drugsupply/pc2.asp • Expectedmarket outlook: • UNITAID market landscape and technical report for key health products. E.g. HIV/AIDS medicines technology and market landscape, TB medicines technology and market landscape, malaria medicines landscape http://www.unitaid.eu/images/marketdynamics/publications/HIV-Meds-Landscape-March2014.pdfhttp://www.unitaid.eu/images/marketdynamics/publications/UNITAID-TB_Dx_Landscape-Update_Dec%202013.pdfhttp://www.unitaid.eu/images/marketdynamics/publications/UNITAID-MalariaMedicinesLandscape-2013_DEC.pdf

  18. page n °18 WHO medicinesprequalification | CPhI China | June 2014 • Joint WHO-UNICEF-UNFPA meeting with manufacturers and suppliers of diagnostic products, finished pharmaceutical products, active pharmaceutical ingredients and vaccinesCopenhagen, Denmark, from  22 to 25 September 2014 • The meeting will cover: • market demand and product priorities • new product development • updates on WHO prequalification procedures and guidelines • procurement policies of international procurement agencies and major donors • Day 3 of the meeting will focus on medicines and diagnostics for reproductive health (including markets, product development and quality issues). • Manufacturers will have the opportunity to meet with assessment and inspection teams to discuss potential or current applications for evaluation), and with members of the procurement teams of UNICEF and UNFPA. • Further information available on PQP website: http://apps.who.int/prequal/

  19. page n °19 WHO medicinesprequalification | CPhI China | June 2014 • Part 2

  20. page n °20 WHO medicinesprequalification | CPhI China | June 2014 • Surveys and qualitative research • Client focus: understanding perspective of manufacturers • Survey: finished pharmaceutical product (FPP) manufacturers in 2010 • Investigation into benefits of WHO prequalification for manufacturers of medicines for HIV/AID, TB and malaria in 2011 • Qualitative research: active pharmaceutical ingredient manufacturers in 2012 • Investigation into differences, with respect to prequalification, between manufacturers of HIV/TB/malaria medicines and manufacturers of reproductive health medicines in 2012 • Research into antiretroviral supply/market • Improving WHO prequalification service • Follow up from survey research • Incremental improvement • Innovation • Diagnostics, medicines and vaccines prequalification merged into a single unit

  21. page n °22 WHO medicinesprequalification | CPhI China | June 2014 • Perceptions of PQP of FPP manufacturers (1)

  22. page n °8 WHO medicinesprequalification | CPhI China | June 2014 • Perceptions of PQP of FPP manufacturers (2)

  23. page n °23 WHO medicinesprequalification | CPhI China | June 2014 • Perceptions of PQP of FPP manufacturers (3)

  24. page n °24 WHO medicinesprequalification | CPhI China | June 2014 • Not all was good…. • E.g. Question 7B.4:In responding to the statement "when it comes to providing an efficient process to resolve issues and questions raised during the assessment of product dossiers", manufacturers have indicated that PQP does not meet their minimum expectations. • A paragraph advising manufacturers what action they can take in the event of a disagreement was added to each assessment and inspection letter sent by the team to manufacturers. • E.g. Question 18.7: When asked how strongly they agree or disagree with the statement "WHO GMP requirements are more stringent than EU or US FDA GMP requirements", the majority of manufacturers indicated that they were more stringent • WHO does not wish to be perceived as more stringent than a stringent regulatory authority. Comments from manufacturers in the survey did not help to identify the reasons for the perception. An agenda item to discuss this was included in a meeting on GMP with manufacturers in 2011. No specific areas of stringency were identified. In fact, WHO was commended for having guidelines to clarify GMP requirements. This is seen as helpful to manufacturers.

  25. page n °25 WHO medicinesprequalification | CPhI China | June 2014 • Timeline to prequalification

  26. page n °26 WHO medicinesprequalification | CPhI China | June 2014 • Improvements to timeline to prequalification (1) Time to prequalification 2009‒2013: median total time, median WHO time, median manufacturers’ time

  27. page n °26 WHO medicinesprequalification | CPhI China | June 2014 • Improvements to timeline to prequalification (2)

  28. page n °28 WHO medicinesprequalification | CPhI China | June 2014 • How were the improvements achieved? • Better guidance, e.g.: • Guidelines on submission of documentation for a multisource product for the WHO Prequalification of Medicines Programme: quality part • Specific guidance, e.g.: • Additional guidance for submission of applications for prequalification of zinc sulfate tablets and zinc sulfate oral liquid • Guidance on bioequivalence studies for reproductive health medicines • Questions and answers on magnesium sulfate injection applications • Engage and communicate: • Assessment team is accessible and open to consultation pre-submission and after submissionDuringinspections inspection team will review manufacturer GMP plans: saves manufacturers time (and expense) • Training workshops, annual meeting with manufacturers

  29. page n °29 WHO medicinesprequalification | CPhI China | June 2014 • In summary • Institutional market sizes offer many opportunities • Those products need to be quality-assured • Prequalified = quality-assured • WHO Prequalification Programme offers guidance and support to manufacturers who are committed to attaining prequalification of their products. • With many thanks for your attention

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