Hans M Vemer

Quality of family planning productsthe view of the pharma industry

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”.

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, 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

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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 counselingno formal counseling.

Saeed GA, et al. Contraception 2008;77:377–381

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

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

Train-the-Trainer course

Trainer

The trainees

Training session artificial arm

Transfer of product knowledge and skills

Train-the-Trainer course

Clinical practice

Live insertions

Practicecounseling

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 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

Any contraceptive method is better than none, . . .

. . . but choice of method makes a difference

CONTRACEPTION

Long term partners based on trust

Hormones and all that chickenwire thing

It’s not that simple………