EUROPEAN COMMISSION
	ENTERPRISE DIRECTORATE-GENERAL
	Single market, regulatory environment, industries under vertical legislation  Pharmaceuticals and cosmetics
		Brussels,
		F4/AN D(2000)

Answers to be sent to Philippe BRUNET before the 15 of July 2000

Thank you very much by anticipation for your contribution

QUESTIONNAIRE ON ADVERTISING AND E-COMMERCE

General on advertising:

1) Do you believe that Europe has a distinctive approach within the global environment to considering advertising/information (particularly on the Internet)?

If so: what are the main elements of that distinctiveness and how does that distinctiveness need to be taken forward?

1 - Non prescribed medicinal products

2) Advertising is not restricted for medicinal product which are not under prescription. Do you have national rules for this sort of medicinal products?

3) Do you think that harmonised positions concerning these medicinal products are needed?

4) Do you think it is necessary to harmonise the classification?

5) Do you think it is necessary to harmonise the conditions for switching to non prescription status?

6) Do you think it is necessary to have better information about the medicinal products subject to such a switch in the Member States?

II - Medicinal products under prescription

7) How do you assess the publication by the EMEA on its web site of EPARs (with SPCs and labelling) of centrally authorised medicinal products?

8) For medicinal products authorised nationally, do you implement/suggest the same publication?

9) Do you have other medias for the information on medicinal products under prescription in your Member State?

10) Do you think that this kind of publication can induce some effects on the pricing and reimbursement system?

11) Do you think that it is necessary to clarify in the legislation the relationship between information and advertising?

12) Do you think that it is necessary to clarify in the legislation that this kind of publication cannot be considered as advertising?

13) Do you think that other clarifications are necessary in the field of advertising? If yes, what clarifications?

14) Do you think that it could be useful to give possibilities for the Marketing Authorisation Holder to give more information?

15) Do you think that it would have a public interest as far as certain classes of medicinal products are concerned? If yes, on which classes of medicinal products could it be possible to start?

16) Do you think that in this case a control should be organised?

17) Do you think that the control should be done by the EMEA for the relevant national competent authority?

18) If not by whom?

19) Do you think that in this case additional rules should be defined? If yes, which kind of rules/guidance should be issued?

20) Do you have any experience in your Member State on the possibility to have information legally provided to the consumer other than the SPC and the labelling?

III - Distribution of Pharmaceuticals

21) What are the major benefits that you see in the use of new IT technology for the distribution of pharmaceuticals?

22) What are the major risks that you see in the use of new IT technology for the distribution of pharmaceuticals?

23) In case of illicit use of IT technology how are these risks being managed in the organisation/interest that you represent?

24) In case of adoption of specific rules for the use of IT technology in this sector how might these rules be implemented?

25) What is your experience of the current practice - and future potential - of electronic prescribing?

26) How do you assess the likelihood - and the risks and opportunities - of new systems developing to use IT technologies within the different health systems (eg. innovative ways of distributing reimbursed pharmaceuticals to patients)?

IV - Other issues that you would like to address

	Contents page
	Correspondence with government