1. Hans M Vemer Quality of family planning products the view of the pharma industry

2. Responsibility for private and for public sector  Company A: “We have created numerous programs and public-private partnerships to help improve healthcare capacity and improve access to our products, so all can benefit, wherever they live.”  Company B: “...we support the cause of giving people access to methods of family planning, irrespective of their economic situation.”  Provide products,  and all product support,  of assured quality  for “cost-plus”.

3. Good quality products. What do companies mean?  Products of assured quality, including the whole accompanying package, at cost-plus.  The package consists of:  The actual product  Education  Constant quality assurance  Follow-up  Sustainability  Choices

4. Why is quality so important in family planning products?  Healthy consumers, not patients  so we need a very high benefit-risk ratio.  Quality is the same everywhere  a woman in Uganda is entitled to the same quality of care as a woman in the United States.  Quality can help registration  and act as a reference for authorities in less-resourced countries

5. Quality = Quality Couples in Uganda are entitled to the same quality of product and product information as couples in the USA.

6. Why is quality so important in family planning products?  Healthy consumers, not patients  so we need a very high benefit-risk ratio.  Quality is the same everywhere  a woman in Uganda is entitled to the same quality of care as a woman in the United States.  Quality can help registration  and act as a reference for authorities in less-resourced countries

7. Education Either by the companies, or preferably with others: NGOs, MoHs, Med.Socs.  Awareness  Posters, media, etc  Teaching of users  What do products (not) do  Training of providers  Actual product training  Training in counseling  Helping with guidelines, etc

8. 8 Counseling postpartum increases decision to use, and actual use of, contraception Contraceptive use and decision about use after 20-minute informal counseling session with husband or close relative present plus educational leaflets, versus no formal counseling no formal counseling. Saeed GA, et al. Contraception 2008;77:377–381

9. Counseling pre-abortion can substantially increase contraceptive use Yassin AS, et al. J Fam Plann Reprod Health Care 2005;31:115–116 2003: Targeted counseling in pre-abortion session 2000–2001: Poor counseling

10. Education Either by the companies, or preferably with others: NGOs, MoHs, Med.Socs.  Awareness  Posters, media, etc  Teaching of users  What do products (not) do  Training of providers  Actual product training  Training in counseling  Helping with guidelines, etc

11. Train-the-Trainer course Trainer The trainees Training session artificial arm Transfer of product knowledge and skills

12. Train-the-Trainer course Clinical practice Live insertions Practice counseling

13. The Four Gs  GCP: Good Clinical Practice  especially in clinical development: rights of subjects, reliability of data, adequate reporting  GMP: Good Manufacturing Practice  products are safe, pure and effective, guaranteed by record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, complaint handling  GDP: Good Distribution Practice  controlled storage and distribution conditions  inventory control at central level and in-country  working capital vs. quick using of funds  GLP: Good Laboratory Practice  consistent and reliable data generation  during development  during quality testing

14. Independent quality assurances ISO qualification  International Organization for Standardization:  voluntary adherence to strict quality standards WHO pre-qualification  WHO in cooperation with national regulatory agencies and partner organizations  unified standards of quality, safety and efficacy FDA and/or EMEA approval  Because people in all countries have a right to the same quality

15. Follow up  Where do the products go?  Are the providers well trained?  Are the users well informed?  Where can users go with problems?  How is AE reporting organized?

17. Sustainability Now  Reliability of supply  Reliability of supply date  Acceptable shelf life  Regulatory approvals Future  Will the company be there in three or five years  With the same range of products  Also for removal  Or in case of problems: long-term commitment

19. Product range Choices  hormonal and non-hormonal  oral and non-oral  reversible and irreversible  short term and long term Innovation  newer, better, even safer molecules  alternative delivery systems  more efficient, cheaper, production methods  all with evidence based methods

21. Any contraceptive method is better than none,...... but choice of method makes a difference CONTRACEPTION

22. Long term partners based on trust

23. Hormones and all that chickenwire thing It’s not that simple………

26. Counseling postpartum increases decision to use, and actual use of, contraception Contraceptive use and decision about use after 20-minute informal counseling session with husband or close relative present plus educational leaflets, versus no formal counseling. Saeed GA, et al. Contraception 2008;77:377–381