(2002; 166 pages)
Medicines and the Internet - regulatory approaches in Singapore
Dr John Lim, Singapore
The Internet challenges traditional controls on medicinal products and may pose risks to consumers, for example, allowing inappropriate access to unapproved medicines. Furthermore, advertising information over the Internet could be unreliable. The challenge for regulators is to safeguard public health and promote the safety, efficacy and quality of medicines, without losing the advantages of the new technology.
The Internet is a new means of delivery of goods and services. Its use to supply pharmaceuticals in Singapore is governed by the Medicines Act, which controls supply of medicinal and related products including western medicines, Chinese proprietary medicines, cosmetic products, contact lens substances, etc., provides for the licensing of all medicinal products, manufacturers, wholesalers and importers, and enables the regulation of the safety, efficacy and quality of medicinal products in the country. A new Health Products Act is being drawn up with wider scope and greater flexibility.
Two key concerns are emerging in Singapore: the sale of medicines through the Internet, and the advertising of health information. A survey conducted in July 2001 revealed that around 1% of consumers purchased drugs from other countries through the mail or Internet. It is likely that the percentage will increase, bringing increased risks of inappropriate access, misinformation and lack of patient counselling.
In Singapore, the Internet sale of medicines is regulated using the same basic principles as apply to conventional pharmacies. All online pharmacies must be extensions of services provided by licensed bricksand- mortar pharmacies, supervised by registered pharmacists. Dispensing of prescription medicines still requires a physician’s prescription. The use of electronic prescribing is being currently under review. As a matter of fact, the Health Sciences Authority (HAS) has approved the first hospital online pharmacy, under the conditions that it shall be for the online sale of prescription refills only, that patients will be counselled on their medication by pharmacists over the phone, and that medicines shall be delivered to patients in a secure and reliable manner.
For the regulation of Internet advertisements and dissemination of health information originating from Singapore, only “pharmacy” and “general sales list” medicines are allowed to be advertised. Permits from the Centre for Pharmaceutical Administration are required for all advertisements and sales promotions. Advertisements must not contain false or misleading claims. Singapore health Websites are screened regularly, and site owners with noncompliant materials are required to remove them. Better coregulation with the pharmaceutical industry is also being explored to achieve greater cooperation through a more efficient and less complicated process. For sites outside Singapore, the approach is to empower consumers to make informed choices by stepping up public education efforts and provision of objective and unbiased information.
As recommended by the Drug Cost Review Task Force in December 2001, HSA advises consumers on the dangers of buying drugs over the Internet, and on transparency of prescription charges and drug prices, and empowers consumers to make informed choices on medicines and their appropriate use,. One approach is by providing information through the HSA Website, with links to other reliable sites. The formation of a National Committee on Quality Use of Medicines is under consideration.
In conclusion, in the Internet era, all regulatory agencies need to take measures to protect public health within their respective jurisdictions by enhancing active cooperation and collaboration among national agencies. Public education is the key to empowering consumers to assess medicinal and health information on the Internet.