Quality of family planning products the view of

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

Responsibility for private and for public sector § Company A: “We have created numerous programs and publicprivate 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”.

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

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

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

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

Education Either by the companies, or preferably with others: NGOs, Mo. Hs, 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

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 8

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

Education Either by the companies, or preferably with others: NGOs, Mo. Hs, 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

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

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

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

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

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?

Sustainability Now § 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

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

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

Long term partners based on trust

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