Compliance Hub ‘ Compliance in the New World ’

1. Compliance Hub‘Compliance in the New World’ Internet Law– 30 June 2011 Dr Rosanna Cooper Tariq Sayfoo Telfords Yard, 6/8 The Highway London, E1W 2BS Tel: +44 0207 488 9947 Fax: +44 0207 481 4197 Email: enquiries@rtcooperssolicitors.com Website: www.rtcoopers.com 30 June, 2011

2. Benefits • What Internet Law entails? • Protection of Intellectual Property Rights • Advertising • Content Liability

3. Objectives • Overview of the Legislative Framework • Online Obligations of Pharma • Trade Mark • Trade Libel • Counterfeit Products • Specific areas that Apply to Pharma • Misleading Advertising • Content Liability • Terms & Conditions • Privacy Policy

4. Online Obligations of Pharma

5. What should Pharma do on the internet? Companies Act 2006 EC Commerce Directives Disability Act Companies Act 2006 Pharma must display its registered name on its website Also, company number, place of registration and registered office address Non-compliance can result in a fine Online Obligations of Pharma

6. Obligations of Pharma • E-Commerce Directives: • The Electronic Commerce Directive (00/31/EC) • The Electronic Commerce (EC) Regulations 2002 (SI 2002 No.2013) • Does it apply to you? • The Regulations refer to an “information society service” – defined as: • "any service normally provided for remuneration at a distance, by means of electronic equipment for the processing (including digital compression) and storage of data, at the individual request of a recipient of the service."

7. Online Obligations of Pharma • BUT, this covers more than just e-commerce businesses and is not restricted to buying and selling online. • "The requirement for an information society service to be 'normally provided for remuneration' does not restrict its scope to services giving rise to buying and selling online. It also covers services (insofar as they represent an economic activity) that are not directly remunerated by those who receive them, such as those offering online information or commercial communications (e.g. adverts) or providing tools allowing for search, access and retrieval of data."

8. Online Obligations of Pharma • Certain minimum information should be provided by service providers (whether involved in e-commerce or not):- • Name of the service provider on the site. This might differ from the trading name and any such difference should be explained. • Service provider’s email address must be given. It is not sufficient to include a 'contact us' form without also providing an email address. • Geographic address of the service provider must be given. • Company's registration number (if applicable) should also be given. • If the business is a member of a trade or professional association, membership details, including any registration number, should be provided. • If the business has a VAT number, it should be stated – even if the website is not being used for e-commerce transactions. • Prices on the website must be clear and unambiguous. Also, state whether prices are inclusive of tax and delivery costs.

9. Online Obligations of Pharma • Some requirements of other laws overlap, for example: • The Distance Selling Regulations contain various information requirements for businesses that sell to consumers over the web. • If the service provider is a company, there are requirements under the Companies Act 2006 (see above).   • How does the E-Commerce Directive affect the formation of online contracts? • Certain information should be given by the seller before orders are placed electronically by consumers or businesses. The seller must provide the following, "in a clear, comprehensible and unambiguous manner“: • the technical steps to follow to conclude the contract; • whether or not the concluded contract will be filed and whether it will be permanently accessible; • the technical means for identifying and correcting input errors prior to placing orders; • languages offered for the conclusion of the contract; • provide a link to any relevant codes of conduct to which you subscribe (unnecessary if the contract is concluded by email); and • terms and conditions of the contract must be made available in a way which allows a user "to store and reproduce" them (again, unnecessary if the contract is concluded by e-mail).

10. Online Obligations of Pharma • When selling to consumers (healthcare) online, you must:- • Provide the ability to identify and correct input errors before completing their orders; and • Acknowledge receipt of the order as soon as possible by electronic means (though the acknowledgement may take the form of the provision of the service paid for where that service is an information society service, such as a song download). • Not applicable where Pharma are not selling online • Disability Act • Website accessibility • Discrimination

11. Trade Marks

12. Trade Marks • Trade mark infringement discovered on the Internet; • Inappropriate allegations of trade mark infringement; • Domain name disputes; • Trade mark infringement and domain names; and • Trade mark dilution and domain names.

13. Trade Libel

14. Trade Libel • Malicious falsehood • What amounts to trade libel? • Libellous statements; • What are the risks? • Serious damage to business; • Damage to business goodwill and reputation; • Exclusion of liability;

15. Advertising

16. Advertising on the Internet • Advertising Regulations • The Business Protection from Misleading Marketing Regulations 2008 • The Consumer Protection from Unfair Trading Regulations 2008 • All Advertisements should be legal, decent, honest and truthful. • Advertisements must comply with the law. • Cannot be offensive (the standard is a prevailing standard of decency) • Cannot be misleading • Advertisements must conform with the Codes • Advertisers have the primary responsibility for observing the Codes • Advertisements must be Capable of Substantiation • Key point: any claims in advertisements must be capable of substantiation

17. Advertising on the Internet • All documentary evidence must be kept in case the ASA requests this evidence • Applies to all non-broadcast electronic media • Pharma can only place factual information on its website regarding non-prescription medicines. • Advertising medicines which have not been granted a marketing authorisation or advertising prescription only medicines (POMs) to the public is banned. • Advertisements cannot exaggerate the properties of the non-prescription medicines and cannot be misleading. • The promotion of POMs to the public on the Internet is prohibited - No benefits can be included on websites about POMs especially the risk of such medicines as they are regarded as promotional claims.

18. Advertising on the Internet • Main legislation governing advertising of medicines are: • The Medicines (Advertising) Regulations 1994 (SI 1994/1932); • The Medicines (Monitoring of Advertising) Regulations 1994 (SI 1994/1933), both as amended (“Advertising Regulations”) prohibit advertising of POMs to the public. • The Advertising Regulations prohibit advertisements directed exclusively or principally at children (under-16s). • In the UK, the advertising of POMs is governed by the Association of the British Pharmaceutical Industry (ABPI) Code of Practice (“Code”), which is regulated by the Prescription Medicines Code of Practice Authority (“PMCPA”). • Consumers must not be misled with regard to the benefits of the medicine in comparison to other similar products.

19. Advertising on the Internet • Pharma risk prosecution for any misleading advertisements under the Advertising Regulations. • Four limited exemptions for advertising under the Advertising Regulations: • The content and form if labels and package leaflets as they are regulated separately; • Correspondence providing answers to specific questions about particular medicines; • Factual announcements; and • Information on health and disease with no reference to medicines. • Recent clarification on advertising of medicines in the preliminary ruling by the European Court of Justice (ECJ) in the case of Vestre Landsret – Denmark: Criminal proceedings against Frede Damgaard(C-421/07 Judgement of the Court 02/04/2009)

20. Advertising on the Internet • The ECJ held that under European law “dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising ..., even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product”. • Pharma must ensure that any information about medicines placed on their websites is accurate, factual and well balanced. • Such sites must only inform the public rather than promote medicines. • Articles that discuss potential treatments will not fall within the scope of the Advertising Regulations.

21. Advertising on the Internet • Information on a particular condition or disease may be provided on websites. • The advice from the The Medicines and Healthcare products Regulatory Agency (“MHRA”) is that, “... when providing information relating to POMs. This should be presented in the context of a balanced overview of all treatment options and relevant disease information”. Specific POMs should not be promoted as this is likely to encourage the purchase of a POM and contravene the Advertising Regulations. • The Advertising Regulations define advertisements broadly, as any “activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”.

22. Advertising on the Internet • The European Commission (EC) has been looking at: • Ways to improve patient access to information on health and medicines. • EC’s proposals to legislate direct-to-consumer advertising of prescription drugs • European Parliament’s Environment, Public Health and Food Safety Committee’s verdict on such proposals (September 2008) • Reservations on direct communication of Pharma to General Public • Revised proposal of prior approval of any “information” from pharmaceutical companies by health authorities before being made available to the public.

23. Advertising on the Internet • Reservations on direct communication of Pharma to General Public Cont’d • Health authority control for the distribution by health professionals of brochures and “patient-information” from pharmaceutical companies. • Continuing discussions • Centre on advertising of POMs to members of the public. • Rise in POMs being sold illegally on the internet • Sale of POMs on rogue internet websites

24. Specific Issues

25. Specific Issues • Counterfeit drugs • Supply chain • Register goods with Customs • Offence of unauthorised use of Trade Mark • Section 92 Trade Marks Act 1994 • Acted honestly; and • Intent to infringe a registered trade mark • Statutory defence • Section 92(5) Trade Marks Act 1994 • "It is a defence for a person charged with an offence under this section to show that he believed on reasonable grounds that the use of the sign in the manner in which it was used, or was to be used, was not an infringement of the registered trade mark."

26. Statutory defence cont’d What to prove for successful defence: A reasonable belief that manner of use of sign did not infringe registered trade mark; and Assertion that products were genuine Penalty Summary conviction - 6 months’ imprisonment and/or statutory fine; or Indictment – Unlimited fine and/or up to 10 years imprisonment Guidance MHRA ABPI Specific Issues

27. Specific Issues • Regular review of Terms and Conditions to ensure fully protected • Due diligence • Compliance • Review of privacy policy • Social Networking Sites

28. E- Marketing

29. E-Marketing Latest Development Directive The Privacy and Electronic Communications (2002/58/EC) – see the Privacy and Electronic Communications (EC Directive) Regulations 2003 Constraints on the use of e-mails, SMS marketing and Website cookies

30. Risks • Cloned websites • Misrepresentation • Misleading advertising • Content liability • Website kept up-to-date • Exclusion of liability in Terms and Conditions

31. Risk Management • Compliance with E-Commerce Directive • Monitoring/Vigilance of Websites and content • Compliance with Advertising Regulations • Liability of the agency and/or pharma in relation to any research e.g. clinical trial subject withdraws or is injured. • Insurance • Indemnity • Cannot exclude liability for death or personal injury • Data Protection • Compliance with the Data Protection Directive as implemented by Member State, for example safeguards for protection of personal data • Transfer of data outside the European Economic Area

32. Case Studies

33. Case Study 1 • A newly formed Pharma is looking to set up its website. What can Pharma put on the site? What issues should Pharma pay particular attention to? • proper terms of use • if taking details of members of public – privacy policy • if using cookies – obtain consent • if providing information about products – clear the information with legal advisers to ensure they comply with Code of Advertising, ABPI and are not misleading • information placed on the website is up-to-date – content liability • policy to make sure the name is not being used • contracting online – although providing service

34. Case Study 2 • An agency which was looking to provide research services to Pharma sought advice on its intended contractual relationship with the Pharma company • Non-disclosure Agreement • Ownership of rights & data • Clearly defined roles • Indemnity • Intellectual Property • Limitation of liability • Data Controller/Date Processing • Outsourcing Agreement

35. Conclusion

36. Conclusion • Proper advertising and maintenance of website (and its contents) is a very important issue for all organisations, including Pharma. • Make sure you know what the consequences of your actions are! • Professional legal advice is crucial to staying on top of things! • Trouble is easily avoided!

37. Further Information: RT Coopers Solicitors Telfords Yard, 6/8 The Highway London, E1W 2BS Tel: +44 0207 488 9947 Fax: +44 0207 481 4197 Email: enquiries@rtcooperssolicitors.com Website: www.rtcoopers.com THANK YOU