Introduction to the D T JV T aipei Symposium

1. Introduction to the DTJV Taipei Symposium Dr. Wilhelm Volk1 A Pharma International

2. Introduction to the DTJV Taipei Symposium • facts & trends affecting the pharmaceutical world • definition of Generic pharmaceutical product • different areas of the law are applicable/important • patent law • pharmaceutical law (marketing authorisation) • social law (financing) 1 A Pharma, part of Sandoz, a Novartis company

3. facts & trends across the world • funding of health care is a world wide problem • public health care systems face financial problems due to the rising of cost and the decreasing of contributions • where no public health care exists access to drugs is often limited to a small group as most people can not pay the prices of high quality medicine • ca. 80 % of world population can not afford Big Pharma/originator products 1 A Pharma, part of Sandoz, a Novartis company

4. facts & trends across the world 1 A Pharma, part of Sandoz, a Novartis company

5. facts & trends across the world • Governments introducing programs in order to increase the Genericsshare (e.g.Lebanon) • Increasing incentivization of patients to ask for low-price products(e.g., co-payments in Poland) • State programs for special patient segments (e.g., welfare patients in Hungary) focusing on lowest available price • tenders are increasingly important, only the price matters (Germany) • ca. 80 % of world population can not afford Big Pharma products 1 A Pharma, part of Sandoz, a Novartis company

6. facts & trends across the world Approximately 30,000 children die each day, 2/3 of them because they lack access to high quality essential drugs that often cost less than a cup of coffee.A short list of preventable and treatable diseases accounts for approximately 70% of childhood illness and death. 1 A Pharma, part of Sandoz, a Novartis company

7. facts & trends across the world So what can be done ? 30 -40 years ago the first so called Generic Pharmaceuticals (GX) appeared on the scene today in most countries of the world they are the drugs of choice and cover the most part of the populations need (in terms of units) 1 A Pharma, part of Sandoz, a Novartis company

8. “Generic medicinal productshall mean a medicinal product which has the same qualitative and quantitative composition in active substances the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. (Regulation 726/2004 and Directive 2001/83/EC. Article 10, paragraph 2, point (b)) Definition of a generic medicine in the European Union 1 A Pharma, part of Sandoz, a Novartis company

9. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form.” (Regulation 726/2004 and Directive 2001/83/EC. Article 10, paragraph 2, point (b)) Definition of a generic medicine in the European Union 1 A Pharma, part of Sandoz, a Novartis company

10. different areas of the lawpatent law • usually new pharmaceutical products are protected by different patents • the patent owner can prevent anybody else from using such product during the patent life an has with this exclusivity • a generic manufacturer either has to wait until the patent expires or finds ways to develop a product which is not within the scope of the patent • in both cases he needs to demonstrate that his product is the same as the originator product according to the Generics definition above 1 A Pharma, part of Sandoz, a Novartis company

11. different areas of the lawpatent law (GX products on the boarder waiting for patent expiry) 1 A Pharma, part of Sandoz, a Novartis company

12. different areas of the law pharmaceutical law • usually a pharmaceutical product (Originator or Generic) must not be sold without authorization of the government • this so called Marketing Authorisation (MA) is obtained via complex administrative procedures to ensure safety of the product • those procedures can vary a lot from country to country and are governed by the pharmaceutical law • in Europe most regulations are harmonised, so that the same rules apply in the whole Union • the challenge is to receive the MA at the latest on the day of patent expiry 1 A Pharma, part of Sandoz, a Novartis company

13. different areas of the law pharmaceutical law • (documentation to obtain MA, so called "Dossier", can be extensive) 1 A Pharma, part of Sandoz, a Novartis company

14. different areas of the law social law (financing) • a lot of countries in the world have a public healthcare system paying for necessary treatment including drugs • most public health care systems are under constant financial pressure: • eg. due to ageing population, progress in science with new (and often expensive) treatments • in some countries prices for drugs are regulated either directly or indirectly, the use of cheap drugs is encouraged • those measures are often regulated by the so called social law 1 A Pharma, part of Sandoz, a Novartis company

15. different areas of the law social law (financing) • (somebody has to pay for the drug) 1 A Pharma, part of Sandoz, a Novartis company

16. Introduction to the DTJV Taipei Symposium • All areas of the law must be regarded the time of launch • patent law • pharmaceutical law (marketing authorisation) • social law (right price) • to bring a Generic product successfully to themarket; if only one aspect is missing the product will not have an impact • if it comes later than the competition usually the market is gone (there is no second winner) 1 A Pharma, part of Sandoz, a Novartis company

17. Introduction to the DTJV Taipei Symposium (a generic not respecting all aspects of the law is good for the dustbin) 1 A Pharma, part of Sandoz, a Novartis company