Access to EC requires that a product be manufactured, registered, and marketed:

Manufacturing an EC Product

When ICEC was founded, dedicated EC products were virtually unknown. Women were relying on the Yuzpe regimen, which involves taking conventional combined oral contraceptives at a higher dose. While this method is effective and is still widely used (see www.not-2-late.com for a list of oral contraceptives that can be used), a dedicated product, which is registered and labeled for emergency use, offers a number of advantages:

• The progestin-only formulation available in most dedicated products is more effective than the Yuzpe regimen, and women report fewer side effects after using it.
• A product that is specifically packaged and labeled for EC provides clear dosage information and is easier to use. This is especially important for women without easy access to a trained provider or other sources of information, such as the internet.
• A dedicated EC product add credibility and legitimacy in eyes of providers and consumers.

One of the first tasks of the Consortium was to work with the pharmaceutical industry to bring a dedicated EC product to the market. Gedeon Richter, a Hungarian company well known for its hormonal products, agreed to repackage its post-coital contraceptive, Postinor, specifically as an emergency contraceptive method, called Postinor-2. Containing 1.5 mg of levonorgestrel in two pills, Postinor-2 is now registered in over 40 countries. And, as of 2006, more than 20 other companies are now manufacturing emergency contraceptive pills and over 130 countries have at least one dedicated EC product registered.

Facilitating Product Registration

In virtually every country of the world, local regulatory agencies must approve any drug being introduced. This process of obtaining approval to market a drug, commonly called the registration or NDA (New Drug Application) filing, involves preparation of a registration dossier, which describes in detail the formulation, manufacturing process, packaging, results of clinical research and quality tests, and other specifics about the product. Applications for drug approval are generally submitted by the product manufacturer or their locally licensed distributor.

Consortium experience shows that public-sector agencies and NGOs can facilitate the registration process in several ways. First, these groups can approach the in-country distributor with a request for the drug and an indication of the potential demand for the drug from within their programs. Knowing that there is a market for a product may spur a distributor to pursue registration. Second, public-sector groups can help the distributor build support for the product among local policy makers, community leaders, and physicians, many of whom may be influential in the registration decision. Finally, where the manufacturer does not have a local presence, local NGOs that distribute other health-related products are likely to be familiar with registration procedures and can facilitate the process through their on-the-ground presence.

Public-sector agencies wishing to encourage registration of a particular emergency contraceptive product in their country are urged to contact the product manufacturer's local distributor directly (the manufacturer can provide the name and contact information of the local licensed distributor). A list of EC products and their manufacturers can be found through ICEC's searchable database. (ICEC does not endorse or guarantee any particular EC product.)

Non-Prescription Access: A Special Issue

In most countries, drugs are licensed either for prescription-only sales or for sale "over the counter." (In reality, over the counter -- OTC -- access usually means "behind the counter," in that the buyer must request the product from a pharmacist rather than taking it directly from the shelf.) ICEC's Policy Statement, "Improving Access to Emergency Contraception," recommends that women should be able to obtain EC without a prescription, as a means to increasing access and reducing delays - especially important given that we now know that EC is more effective the earlier after unprotected intercourse it is taken. Many other national and international agencies and bodies also recommend non-prescription access to EC. In countries where EC remains prescription-only, providers may consider advance prescription or provision.

In many countries, concerns have been raised about the possible link between increased access to EC and possible changes in sexual behavior or use of on-going contraceptive use. However, a number of studies show that women with greater access to EC are not more likely to engage in unprotected intercourse. As of 2006, 44 countries (and eight states in the US) allow non-prescription sales of EC.

Marketing and Social Marketing

Because awareness of EC is generally low and women need to know enough to gain access to the product within a short time frame, publicizing and marketing EC is important. ICEC members have used a number of strategies to raise awareness of EC, including establishing telephone hotlines and websites, distributing postcards, wallet cards, mouse pads, and other promotional materials, and developing posters and other materials for display in family planning clinics and pharmacies. Local distributors of EC also work to publicize their products.

Social marketing is a strategy to improve health using commercial marketing strategies; this strategy is being applied to increase access to EC in a number of countries by ICEC member agencies. The promotion of EC is ineffective if there is no product to meet potential demand, so social marketing agencies also help to ensure that demand is met by working with distribution networks, providers and pharmacists to ensure that products are available when and where women need them.

ICEC members working on the social marketing of EC include Population Services International and DKT International.