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Harmonisation Accession Europe Experiences of Krka

Harmonisation Accession Europe Experiences of Krka. Dr. Aleš Rotar KRKA d.d., Slovenia. Presentation outline. 1. Krka, CEE companies. Role of generics in Europe. CEE en route to European Union. Negotiations and harmonisation. Accession. 2. 3. 4. 5. Krka d.d.

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Harmonisation Accession Europe Experiences of Krka

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  1. Harmonisation Accession Europe Experiences of Krka Dr. Aleš Rotar KRKA d.d., Slovenia

  2. Presentation outline 1 • Krka, CEE companies. • Role of generics in Europe. • CEE en route to European Union. • Negotiations and harmonisation. • Accession. 2 3 4 5 dr Ales Rotar, KRKA Slovenia

  3. Krka d.d. • Integrated pharmaceutical company. • Private ownership, sales 350+ M EUR • Internationally oriented, more than 80% of sales to 70 export markets. • CEE and Russia are key export markets, EU is becoming one of the most important. • in 60’s Licensed in products introduced (Pfizer, Sandoz, BMS, Janssen, Fujisawa etc.). • In 70’s first FDA approvals for actives • Since early 80’s own generic products. • In 90’s finished dosage forms to EU and US. 1 dr Ales Rotar, KRKA Slovenia

  4. Krka d.d. • GMP at a high level, regularly inspected by various foreign inspections. • FDA approved for active pharmaceutical substances since early 70’s. • FDA approved for finished dosage forms late 90’s. • Holding numerous marketing authorisations in more than 70 countries. • Several MRP’s concluded. 1 dr Ales Rotar, KRKA Slovenia

  5. KRKA’s goals till the year 2005 • to maintain our place among the leading pharmaceutical companies on the markets of central, eastern and south-east Europe, and also to reinforce our position on the developed western markets, particularly in Europe, • to develop new technologiesand launch new products (extending the existing range, entering new therapeutic areas), • to come closer to the markets through own companies and strategic partnerships. 1 dr Ales Rotar, KRKA Slovenia

  6. CEE companies Regional companies: Sales approx. 300 M. Vertically integrated. Quality generics at US and EU standards. Penetration to US and EU, ROW. Privatized through international portfolio or strategic investors. Solid research and developement base, excellent in generics, to small for new molecules National companies: Sales up to 100 M. Less integration. Limited intl. exposure Privatized. Limited developement expertise. 1 dr Ales Rotar, KRKA Slovenia

  7. A view of a regional company • …may only be presented in the broader frame of pharmaceutical market being a result of dynamic equilibrium in the market… • …EU enlargement creates a new equilibrium… • …where public health concern and industrial policy both influence the actual development of the situation. 1 dr Ales Rotar, KRKA Slovenia

  8. Presentation outline 2 • Krka, CEE companies. • Role of generics in Europe. • CEE en route to European Union. • Negotiations and harmonisation. • Accession. 3 4 5 6 dr Ales Rotar, KRKA Slovenia

  9. G 10 on generics in EU - 2002 • The pharmaceutical industry exists to provide medicines for the benefit of the health of patients • The Rx industry has two sectors: innovative and generic and both produce safe medicines of high quality • Vibrant inter-dependent innovative and generic sectors help to provide patients and payors with affordable medicines • Strength in both sectors is required to improve Europe’s competitiveness in the world market 2 dr Ales Rotar, KRKA Slovenia

  10. The growth of generic markets (USD M) 19982003 19982003 19982003 19982003 dr Ales Rotar, KRKA Slovenia

  11. Penetration of generics in EU • Germany 28% value 40% volume • UK 18% value 50% volume • Denmark 35% value 60 % volume • Netherlands 13% value 40% volume • Many others around 2-3% value 3-6% volume but strong developement (Spain, Belgium, Portugal, France and Italy) • USA 20% value50% volume 2 dr Ales Rotar, KRKA Slovenia

  12. G10 on generics in EU - 2002 • Recognised benefit of generics. • Acknowledged need to create a competitive environment for the off patent market. • Acknowledged the need to ensure that generic authorisations are not blocked. 2 dr Ales Rotar, KRKA Slovenia

  13. Presentation outline 2 • Krka, CEE companies. • Role of generics in Europe. • CEE en route to European Union. • Negotiations and harmonisation. • Accession. • Europe. 3 4 5 6 7 dr Ales Rotar, KRKA Slovenia

  14. CEE Europe is influenced by the global trends in pharmaceutical market Scientific development of historic importance. Global development of trade. Cost containment measures. High expectations of customers. High expectations of investors and owners. + - dr Ales Rotar, KRKA Slovenia

  15. CEE Europe is changing rapidly • Pharmaceutical market in the Central EasternEurope is the most dynamic part of the European pharmaceutical market due to: • Accession of several countries to the EU and subsequent economic, political and social changes of the society; • Adoption of EUacquis communautare; • Restructuring of the market for health products and services; • Restructuring of local pharmaceutical industry. 3 dr Ales Rotar, KRKA Slovenia

  16. CEE pharmaceutical markets • Typical emerging markets; • Rapidly developing medical doctrine; • Limited funds to support high expectations regarding healthcare spendings; • Drug expenditure from 140 USD to 7 USD; • Dual extreme pricing issue. 3 dr Ales Rotar, KRKA Slovenia

  17. Presentation outline 2 • Krka, CEE companies. • Role of generics in Europe. • CEE en route to European Union. • Negotiations and harmonisation. • Accession. 3 4 5 6 dr Ales Rotar, KRKA Slovenia

  18. European Accession Agreement - Article 1 • “… to promote the expansion of trade and harmonious economic relations between the Parties and so foster dynamic economic development and prosperity in Slovenia;” • “… to support Slovenia's efforts to develop its economy and to complete the transition into a market economy;” 4 dr Ales Rotar, KRKA Slovenia

  19. Regulatory and legal environment relevant for pharmaceutical industry • Marketing authorisation: procedures, documentation and subjects. • Quality requirements and standards: criteria, procedures, enforcement. • Industrial property: harmonisation with international treaties. 4 dr Ales Rotar, KRKA Slovenia

  20. Expectations of CEE industry • Smooth, step-by-step transition with EU agreements providing stable legal basis. • We intend to become a responsible player of enlarged EU pharmaceutical market - therefore we need resources not only principles. • Not to be punished for the past - pipeline protection and retroactive data exclusivity • Accession should not cause further decline of turnover and drastic employment problems. 4 dr Ales Rotar, KRKA Slovenia

  21. Prague 1998: Suggestions for Productive Development in CEE • Dialogue with all the subjects in the market. • Predictable legal and regulatory environment is a must for the industry to plan and invest. • Careful weighing of risks and benefits, particularly with regards to the existing products’ registration renewals and pricing. Stable goals: how to make them predictable and achievable? • Harmonisation with EU: how to avoid the moving target syndrome? • Two way road vs. one way highway . 4 dr Ales Rotar, KRKA Slovenia

  22. Regulatory procedures in CEE • National procedures; available for all the applicants; • MRP: special procedure available for innovators and EU based companies; • CP: special CADREAC procedure available for innovators; • the issue one way highway instead of two way roadhas not been resolved. 4 dr Ales Rotar, KRKA Slovenia

  23. Existing products harmonization • Revision of the market (and not upgrade of documentation) is an ongoing concern of the national authorities since the early 90’s; • Criteria: • Q, S, E; • Legal basis (gen’x, WEU, …). • Two approaches: stepwise revision and/or transitional periods. 4 dr Ales Rotar, KRKA Slovenia

  24. Q standards • Some accession countries have been founders of PIC, the others are becomming the members during the last decade. • GMP, GCLP, GLP, GCP are legally binding. • Several countries are members of PhEur convention. • The companies operating on int’l markets like US and EU are applying the lates standards since 1970’s. 4 dr Ales Rotar, KRKA Slovenia

  25. Training and education • … there is still more room for exchange of views, experiences and solutions with all the segements of the industry… • … output of CADREAC, PERF etc is determined by quality of communication, which we support very much… • … but doubtfull effect of (semi) commercial seminars with wide range of motives behind the agendas of various parties involved (i.e.: frequent misinterpretation of facts …) 4 dr Ales Rotar, KRKA Slovenia

  26. Presentation outline 2 • Krka, CEE companies. • Role of generics in Europe. • CEE en route to European Union. • Negotiations and harmonisation. • Accession. 3 4 5 6 dr Ales Rotar, KRKA Slovenia

  27. Phasing in • Phasing in of national proceedures into MRP only from the day 1 of accession will severely impact the CEE industry. • CP expected to play role only when appropriate for designated product groups as well as individual cases. • New technologies are still an unanswered question (i.e.: biologicals,…) thorughout EU. 5 dr Ales Rotar, KRKA Slovenia

  28. Expected development in CE EU • National authorities are expected to develop core competencies as well as critical mass of experts to take active role in MRP’s. • Involvement of CEE national authorities in regulatory processes is one of the keys of further developement of the regional pharmaceutical industry. • Industry expects provisions and mechanisms for smooth transition from national into MRP procedures. 5 dr Ales Rotar, KRKA Slovenia

  29. Future role of CE EU pharmaceutical industry • The vertically integrated regional companies are continously developing into major suppliers of quality generics for EU as well as overseas. • Due to absence of any external resources, mechanisms or organised help from institutions this strategic shift has forced the companies to develop high level of scientific, regulatory and operational excellence, however at a very high cost… 5 dr Ales Rotar, KRKA Slovenia

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