IMPACT Principles and Elements for National Legislation Presented by: Chair, Working Group on Regulatory Implementation, on behalf of Chair, Working Group on Legislative and Regulatory Infrastructure

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3 |3 | Working group on legislation: Origin Rome Conference ( Feb 2006) National, regional and international strategies aimed at combating counterfeit medicines should be based on: Political will, adequate legal framework, and implementation commensurate to the impact of this type of counterfeiting on the health of individuals and on public health and providing the necessary tools for a coordinated and effective law enforcement, [ [

4 |4 | History Constitution of the IMPACT legislative working group: Bonn st Expert meeting: Brussels July Meeting experts: Lisbon December 2007 Adoption of the draft : IMPACT General meeting 12 December 2007 Re-adopted at IMPACT General Meeting: December 2008 in Hammamet – charge: expand for devices Opportunity for Comment: Comments due December 31, 2009

5 |5 | Considerations The document is a living document that will be updated taking into account practical experiences in implementation Credibility of the advice requires a clear direction The document needs to be focused on the specific purpose The document must be practical and facilitate legislative initiatives

6 |6 | Goals of comprehensive legal framework (i) Links medical product counterfeiting activities to effective criminal sanctions, and deterrent civil and administrative remedies and penalties; (ii) Adequately regulates and control each link in the supply and distribution chain; (iii) Empowers, directs and provides adequate technical, financial and human resources to medical product regulatory authorities, law enforcement authorities and customs to take effective and coordinated action, encompassing all aspects (including exports and online Internet activity); and (iv) Educates stakeholders about the inherent dangers of counterfeit medical products.

7 |7 | Identified barriers to effective enforcement A definition for counterfeit medical products is absent or inadequate; Counterfeiting medical products is not considered per se to be a serious crime or, in some cases, not even a crime; Where counterfeiting medical products is considered a crime, sanctions are sometimes more lenient than for those crimes applicable to counterfeiters of products that have no implications for health, such as T-shirts; Sanctions are not applicable unless it is proven that counterfeits have actually resulted in injuries or death; The responsibilities of those involved in the distribution system are not clearly defined, there are no provisions for effective coordination and information exchange among various authorities and other stakeholders at the national, regional and international level, There are no provisions allowing authorities to share information nationally, regionally or internationally or to use in legal proceedings the information obtained from others, There are no provisions addressing the problem of trade in packaging and labelling materials without the obvious involvement of the companies whose name appears on these materials, There are insufficient legal provisions concerning the confiscation and use of the assets, equipment and other materials used in conjunction with the manufacture, trade, transportation of counterfeit products.

8 |8 | Definitions Medical products Medical device Counterfeit medical product Manufacturer Operator of the chain distribution Other operators involved Retailers

9 |9 | Responsibilities/obligations outlined for: Government Manufacturers Operators of the distribution chain Retailers Other operators Regional and international cooperation

10 | Illegal acts Prohibitions related to: Manufacturing Transit Possession Export Electronic sale Conspiracy More…..

11 | Sanctions "Given that counterfeiting of medical products represents a serious threat to individual health and jeopardizes health care systems, governments should take all necessary measures to effectively deter the illegal acts described… This includes introducing severe criminal sanctions against perpetrators, regardless of whether evidence exists of actual harm caused to others. The illegal acts described…should be considered criminal offences even if committed by negligence.

12 | Sanctions These sanctions should: reflect the gravity of the respective offences, especially according to the presence and level of guilt, be equivalent to those provided by national legislation for other serious crimes, such as the manufacture or commercialization of dangerous substances or substances harmful to human health or drug trafficking, and include, where applicable constitutions or other instruments permit, mandatory prison sentences.

13 | Type of Sanctions Custodial sentences; Fines; Confiscation of assets including forfeiture of illegal proceeds; Confiscation of instruments, equipment and materials used to commit the crime; Total or partial closure, on temporary or permanent basis, of the establishment(s) involved in the commission of the offence; Permanent or temporary prohibition to engage in medical-product-related activities; Destruction of the counterfeit goods involved in the offences and recovery of the related costs; ban on the access to public assistance or subsidies; Placing the operation under judicial supervision; Judicial order to close or halt the operation and related activities; Indemnification of affected/damaged parties (including affected patients, affected operators, and manufacturers of genuine products); Publication of judicial decisions (including dissemination of information to international organisations and to national competent authorities of other countries); Withdrawal of licences.

14 | Application of the Principles WHO Member States have started to use the document to check their national legislation European Commission proposed new EU legislation based on WHO principles Council of Europe is preparing an international convention against counterfeit medical products based on WHO principles

15 | Counterfeit definition in Principles A medical product is counterfeit when there is a false representation 1 in relation to its identity 2 and/or source. 3 This applies to the product, its container or other packaging or labeling information. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct components 4 or with the wrong components, without active ingredients, with incorrect amounts of active ingredients or with fake packaging. Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. Substandard batches of or quality defects or non-compliance with good manufacturing practices/ good distribution practices (GMP/GDP) in legitimate medical products must not be confused with counterfeiting. 1 Counterfeiting is done fraudulently and deliberately. The criminal intent and/or careless behavior shall be considered during the legal procedures for the purpose of sanctions imposed. 2 This includes any misleading statement with respect to name, composition, strength, or other elements. 3 This includes any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorization holder or steps of distribution. 4 This refers to all components of a medical product.

16 | 1992 WHO counterfeit pharmaceutical product definition A pharmaceutical product which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit pharmaceutical products and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

17 | Next Steps Comments due to WHO by December 31, 2009 Resolve counterfeit definition Prepare for discussion at 63 rd WHA in May 2010

18 | Questions???