1 / 29

Dr. Pasqualino Rossi CHMP member

I farmaci generici nelle prospettive europee VI CONFERENZA NAZIONALE SULLA FARMACEUTICA CATANIA, 16/11/2206. Dr. Pasqualino Rossi CHMP member. - flash - Around Europe. SWEDEN

yitta
Télécharger la présentation

Dr. Pasqualino Rossi CHMP member

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. I farmaci generici nelle prospettive europeeVI CONFERENZA NAZIONALE SULLA FARMACEUTICA CATANIA, 16/11/2206 Dr. Pasqualino Rossi CHMP member

  2. P. Rossi

  3. - flash -Around Europe • SWEDEN • Pharmaceutical prices in Sweden have decreased 15% since introducing generic substitution in 2002 producing estimated accumulated savings of 7 billion Swedish kroner, some $760 million. According to the Swedish Pharmaceutical Benefits Board (LFN), this reform has increased competition between companies, which has lowered prices and released funds for use on other urgent needs in the healthcare system. • www.lakemedelsverket.se P. Rossi

  4. - flash -Around Europe • FRANCE • A French government study of the five major pharmaceutical markets in Europe has shown that promoting the use of generic medicines over high-priced originals is an important factor in reducing pharmaceutical spending. Of the countries surveyed, the United Kingdom boasted the highest penetration of generics and the lowest spending on medicines. • www.sante.gouv.fr P. Rossi

  5. - flash -Around Europe • GERMANY • Savings to the German healthcare system still has great potential if originator products were substituted more frequently by lower-priced generics. In its 2006 Pharmaceutical Report, the Gmünder Krankenkasse (GEK) estimates it could save some $42 million – 11% of its spending – if doctors would prescribe only generic medicines in a limited number of easily treated therapy groups. • www.gek.de P. Rossi

  6. - flash -Around Europe • SWITZERLAND • The Swiss health insurance fund, Santésuiss, calculates that the country could save over ¤ 114 million if originator products were substituted by even their highest priced generic equivalents. The savings would increase to $178 million if the least expensive generics were dispensed. • www.santesuisse.ch P. Rossi

  7. - flash -Around Europe • TURKEY • Generics accounted for 56% by volume of all medicines sold in Turkey and 38% by value according to the 2005 statistics released by the Pharmaceutical Manufacturers Association of Turkey (IEIS). Accordingly, $615 million – approximately 500 million – in savings were generated through the use of generic pharmaceuticals that year. In May 2006 the IEIS launched a campaign to further increase the use of lower priced generic medicines to create even more savings. • www.ieis.org P. Rossi

  8. Focus on genericmedicines Dramatic changes in pharmaceutical markets make it imperative for patients and generic medicines producers to seek out and work with governments to create the best conditions for developing, manufacturing and marketing generic medical products. Innovation and competition in the pharmaceutical sector bring important improvements to healthcare delivery to European patients. P. Rossi

  9. Focus on genericmedicines Generics companies principally develop, produce and market affordable, high quality off-patent medicines. These stimulate innovation by creating price competition and budget headroom for innovation. The saving from lower-priced generic equivalents help finance the reimbursement of new innovative products. P. Rossi

  10. Focus on genericmedicines To encourage breakthrough research, the EU should discourage products with expansive chemical change that offer little or no therapeutic advantage to patients. This can best be achieved by offering real rewards only to products that bring real therapeutic innovation. P. Rossi

  11. We have a problem:The EU’s Ageing Population • “By 2050 there will be only two working age citizens contributing to the support of each elderly person in the EU, instead of four as at present.” • “Citizens aged 65 and over account for 30% to 40% of healthcare spending.” • “... the budgetary impact of ageing is substantial, making it more difficult for Member States to comply with the budgetary requirements of EMU.” P. Rossi

  12. We have a problem:The EU’s Ageing Population • The report continues to warn EU policy-makers that public spending on healthcare will rise by 4% to 8% of GDP over the next few decades, and insists “...that the budgetary impact of ageing is substantial, making it more difficult for Member States to comply with the budgetary requirements of EMU P. Rossi

  13. Generics could offer a solution • One readily available solution to these problems is to be found, in part, in increasing the use of generic medicines. These competitively priced therapeutic equivalents to patent expired originator pharmaceuticals have demonstrated they possess the same quality, safety, and efficacy as their originator products, and they go through the same regulatory procedures. The only difference is their price, which is typically 20% to 80% below that of brand-name originator pharmaceuticals. P. Rossi

  14. Measure needed to improve It is time for the EU to shift its focus from increasing IP protection to making Europe once again the “hotbed” of pharmaceutical research • Creating a European research facility • Building better links between science and business • Increasing Private Public Partnerships • Providing faster access to market for new approved medicines • Reimbursing new medicines according to their added therapeutics value • Creating a Community Patent • Promoting strong generic competition in Europe P. Rossi

  15. Regulation (EC) No 726/2004 • Regulation (EC) No 726/2004, creates a Centralised Community Procedure for the authorisation of medicinal products, for which there is a single application, a single evaluation and a single authorisation allowing direct access to the single Community market. • For generic and hybrid medicinal products eligibility can be granted to the Centralised procedure as follows: P. Rossi

  16. Generic/Hybrid medicinal product of aCentrally authorised product: • Generic/hybrid medicinal product applications of medicinal products authorised via the Centralised procedure have automatic access to the Centralised procedure under Article 3(3) of Regulation (EC) No 726/2004. P. Rossi

  17. Generic/Hybrid medicinal product of aNational/MRP/DCP product: • Generic/hybrid medicinal product applications of medicinal products authorised via the national/MRP/DCP procedure could, at the request of the applicant, be accepted for consideration under the centralised procedure, when the applicant shows that the medicinal product constitutes: • a significant therapeutic, scientific or technical innovation, or • the granting of a Community authorisation for the medicinal product is in the interest of patients at Community level. P. Rossi

  18. Generic medicinal product • According to Article 10 (1) of Directive 2001/83/EC, as amended, the applicant is not required to provide the results of pre-clinical tests and clinical trials if he can demonstrate that the medicinal product is a generic medicinal product of a reference medicinal product which is or has been authorised under Article 6 of Directive 2001/83/EC, as amended, for not less than 8 years in a Member State or in the Community. P. Rossi

  19. Generic medicinal product • A generic medicinal product is defined as a medicinal product that has: • the same qualitative and quantitative composition in active substances as the reference product, • the same pharmaceutical form as the reference medicinal product, • and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. P. Rossi

  20. Hybrid medicinal product • Hybrid applications under Article 10(3) of Directive 2001/83/EC as amended, differ from generic applications in that the results of appropriate pre-clinical tests and clinical trials will be necessary in the following three circumstances: • where the strict definition of a ‘generic medicinal product’ is not met; • where the bioavailability studies cannot be used to demonstrate bioequivalence; • where there are changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration of the generic product compared to the reference medicinal product P. Rossi

  21. Hybrid medicinal product • In such cases the results of tests and trials must be consistent with the data content standards required in the Annex to the Directive 2001/83/EC as mended by Directive 2003/63/EC. • These applications will thus rely in part on the esults of pre-clinical tests and clinical trials for a reference product and in part on new data. Some guidance on the appropriate additional studies required is indicated in Annex IV of the Chapter 1 of the Notice to Applicants. P. Rossi

  22. CTDcommon technical document • Module 1: • In certain cases an EU Risk Management Plan might be required • Module 2: • Quality Overall Summary, Non-clinical Overview and Clinical Overview. Non-clinical and Clinical Summaries can be provided, but they are only mandatory if new additional studies have been provided within the documentation. • Module 3: • A complete Module 3 should be submitted in accordance to the requirements set out in the Notice to applicants. P. Rossi

  23. Module 4 and Module 5 • Generic of a reference medicinal product (Art 10.1) • It is not required to provide the results of toxicological and pharmacological tests or the results of clinical trials. • The results of the bioequivalence studies performed where appropriate should be included. • Hybrid of a reference medicinal product (Art 10.3) • The results of appropriate preclinical and clinical tests should be provided in accordance to the requirements set out in the notice to applicants. P. Rossi

  24. CHMP Guidelines • CPMP/EWP/2158/99 Guideline on the Choise of the Non-Inferiority Margin (Adopted by Committee July 2005) • CPMP/EWP/QWP/1401/98 Note For Guidance on the Investigation of Bioavailability and Bioequivalence (Adopted July 2001) • CHMP/EWP/40326/06 Questions & Answers on the Bioavailability and Bioequivalence Guideline P. Rossi

  25. CHMP Guidelines P. Rossi

  26. TIMETABLE FOR GENERICS APPLICATIONS P. Rossi

  27. TIMETABLE FOR GENERICS APPLICATIONS P. Rossi

  28. EU Risk Management Plan • Generic medicinal product • RMP should be submitted with the application for a if there is a safety concern with the reference medicinal product, which has led to additional risk minimisation activities. • Routine risk minimisation activities are the use of the product information (SPC, Package leaflet and labelling) to reduce the risk to patients. This includes the use of warnings and contraindications in the SPC. • Additional risk minimisation activities are those, which go beyond this and include specific physician, pharmacist or patient educational material or patient alert cards etc. • Hybrid medicinal product • RMP may also be needed even where there is no particular safety concern with the reference medicinal product, if the changes compared with the reference medicinal product suggest that there may be different risks. P. Rossi

  29. What others are saying... •  “Pricing studies have shown unequivocally that generic competition is the most effective way to ensure lasting price reductions.” • WHO 55th AssemblyMay 2002 •  “Prescribing generics in the countries of the European Union is an indispensable alternative to ensuring the optimal allocation of economic resources to develop innovative pharmaceuticals.” • International Association of Medical Insurers (AIM)December 2001 • “Promoting generics can have an important impact in reducing costs and creates headroom to help pay for new innovative products.” • EU Council of MinistersJune 2000 P. Rossi

More Related