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The ABPI Position Paper on
Pharmaceuticals and the Internet (October 2000)
Information and the internet Patients and consumers are seeking more information about medicines
and medical treatments. The Internet has the potential to benefit both
patients and healthcare professionals and be a vital and positive
resource for society. Legitimate and trustworthy sources of
information on medicines exist on the Internet. It can:
- Inform and educate a global audience.
- Provide an easily accessible source of information on medicines
and health care.
The ABPI therefore strongly encourages the appropriate use of the
Internet.
- To provide accurate and scientifically reliable information on
health care and medicines.
- To provide information in a responsible manner.
The ABPI considers that there should be open access to all
information put on the Internet by pharmaceutical companies.
International laws and regulations vary widely on information that
pharmaceutical companies may provide on their products. There is an
opportunity for constructive changes and a need for greater
harmonisation. Inaccurate or misleading information on medicines from unregulated
and doubtful sources is of serious concern and patient safety is of
paramount importance. Unscrupulous people will continue to misuse the
Internet. The pharmaceutical industry should be allowed to educate and
freely inform consumers to correct this imbalance. Rather than trying to restrict patients' access to information, it
is better to educate individuals to be sceptical. Ways of validating
web pages may need to be developed.
The Internet and Self Regulation
Self-regulation is the most appropriate way to manage
pharmaceutical company's product information on the Internet. The
research based pharmaceutical industry has a long tradition and
experience of self-regulation. UK based pharmaceutical companies comply with the ABPI Code of
Practice and pharmaceutical companies world-wide are bound by the 'IFPMA
Code of Pharmaceutical Marketing Practices'. These long established
codes govern marketing and promotional activities. They set out
principles and standards for information provided by companies about
their products. Their requirements apply to information provided via
the Internet.
Sale and Supply of Medicines via the Internet
The focus of control should be on the physical movement of goods
and the need to educate consumers about potential dangers. The
pharmaceutical industry will co-operate with governments, regulatory
bodies and customs to prevent unlawful and harmful distribution of
medical products. The pharmaceutical industry is actively working against:
- Diversion of medicines from recognised trade routes
- Counterfeiting/substandard products
- Unlicensed products being offered for sale
Handling medicines outside regulated distribution channels is
potentially dangerous. There are potential risks to public health if
consumers have access to:
- Poor quality products
- Unlicensed medicines
- Counterfeit medicines
Patients' health may be put at risk by some on-line prescribing
practices and industry supports measures to try to prevent such
activities and to educate consumers about the dangers of procuring
medicines in this way. The ABPI'S view is that it is irresponsible to
have a prescription issued without a proper professional consultation
taking place.
Conclusion
The ABPI is looking forward to working with regulatory authorities
to ensure that the Internet will live up to its enormous potential to
improve the quality of pharmaceutical information, leading to a more
informed and empowered consumer. Collaboration between the
pharmaceutical industry, national and international regulatory bodies,
health professionals, wholesalers and patients is required.
Existing Relevant Legislation
Council Directive 92/28/EEC of 31 March 1992 on the advertising of
medicinal products for human use
This, in essence, forbids advertising to the general public for
prescription-only products and allows such advertising for
over-the-counter (OTC) products.
Council Directive 92/27/EEC of 31 March 1992 on the labelling of
medicinal products for human use and on package leaflets
This sets out requirements for the labelling of products and for
package leaflets.
Council Directive 92/26/EEC of 31 March 1992 concerning the
classification for the supply of medicinal products for human use
This harmonises (on a European level) the criteria which determine
whether a product should be OTC or prescription-only.
Directive 97/7/EC of the European Parliament and of the Council of
20 May 1997 on the protection of consumers in respect of distance
contracts
This regulates horizontally distance selling for any kind of
product. Article 14, states that Member States may maintain their
national policies regarding distance selling of medicinal products. So
for OTC products, member states may allow or ban it as they wish, and
it is forbidden for prescription products.
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