Pharmaceuticals and the Internet Drug Regulatory Authorities' Perspective - Joint NLN-WHI Workshop, 24-25 September 2001
(2002; 80 pages) Voir le document au format PDF
Table des matières
Afficher le documentExecutive Summary
Afficher le documentOverview of activities by the World Health Organization - Dr Lembit Rägo
Afficher le documentOverview of activities by the Nordic Council on Medicines - Dr Ola Westbye
Ouvrir ce répertoire et afficher son contenuCountry Experiences
Afficher le documentThe Danish Consumer Council - Ms Margrethe Nielsen
Afficher le documentSwedish Industry Association - Dr Håkan Mandahl
Afficher le documentIntroduction to discussion points - Dr Lembit Rägo
Afficher le documentQuality aspects - Dr Ola Westbye
Afficher le documentPilot study on drug regulatory web sites: Current status and future challenges - Ms Elodie Jambert
Afficher le documentThe WHO model web site for drug regulatory authorities - Dr Lembit Rägo, Ms Elodie Jambert, Mr Jorg Hetzke
Afficher le documentConcluding discussion
Ouvrir ce répertoire et afficher son contenuAnnexes
Afficher le documentReferences
Afficher le documentBack cover
 

Introduction to discussion points - Dr Lembit Rägo

Discussion points

1. Patient/consumer protection in e-commerce:

• effective protection when purchasing on the Internet;

• same degree of protection as in the real marketplace?

• what further actions on the demand side (beyond the booklet Medical products and the Internet)?

• role of national governments;

• partnerships (professional associations, Internet service providers);

• Children/minors and e-commerce:

• vulnerability to advertisements and commercial messages;

• capability to distinguish between advertising and information;

• limitations on advertising to children?

2. The role and limitations of national regulatory authorities:

• reaching health professionals and consumers;
• improving visibility and improving provision of information.

3. Minimum information about suppliers and products offered:

• essential details about the supplier: name of company, physical address, phone, fax, e-mail, name and address of the licensing body through which the company is registered or authorized;

• geographic scope of trade;

• safe and proper handling/storage requirements;

• information (or non-availability of information) on regulatory status of products or on safety or warnings in countries of origin and destination;

• reference/links to sources of independent information on product safety, use, and efficacy;

• actual costs of delivery, postage and handling, insurance, and customs taxes and duties;

• information on applicable law and the jurisdiction for settling disputes;

• requirements for disclosure of (liable) representative in importing country?

4. Intellectual property and e-commerce:

• international differences in trade names and patent validity;
• challenges to national policies on parallel imports;
• laws and legal rules not harmonized at the international level.

5. Responsibility of exporters and importers/consumers:

• is compliance with importing country’s regulations the responsibility of the exporter or the importer?

• forbid ‘distance shopping’ (e.g., Germany)?

• establish direct-to-consumer e-export licences?

6. Codes of conduct and beyond:

• ‘ethical/fair’ trade guidelines/principles;
• is there a role for manufacturers?
• what challenges for pharmacists’ associations?
• is there a role/challenge for Internet service providers?
• towards an ad hoc global regulation of international e-trade?
• limits to the rights of governments to regulate business to protect consumers and public health?

7. Observatories:

• who should/can monitor e-offers?
• label for legitimate suppliers?
• is there a role/challenge for Internet service providers?
• how can we ensure that international harmonization does not reduce the level of protection provided by existing national standards?

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Dernière mise à jour: le 19 janvier 2012