Pharmaceutical Ingredients - Trends & Enforcement Issues

Transcription

1 Pharmaceutical Ingredients - Trends & Enforcement Issues Dr. Arnulf Heubner Member of the Board Chairman Pharmaceutical Business Committee 27th-29th April, 2008 Dublin, Ireland 1

2 Agenda EC Regulatory Objectives - Pharmaceuticals APIs in the EU - Status Our focus Our activities Heparin business data and monographs Results of our efforts Our next steps 2

3 EC Regulatory Objectives Pharmaceuticals 1. To better protect the health of citizens 2. To strengthen the competitiveness of EU companies These are also EFCG s regulatory objectives for pharma ingredients, but the reality is. The lack of law enforcement to achieve Objective 1 for offpatent APIs undermines the achievement of Objective 2 3

4 APIs in EU Origin of APIs for Europe Until the 1990s more than 80% (volume) of APIs for the EU were manufactured in Europe Today the majority is manufactured in Asia, notably in China and India Does that make a big difference? 4

5 The Differences in API Manufacture Europe Asia Decades of US FDA GMP inspections No (long) US FDA tradition Most API producers by now have been Very few API producers have been FDA and/or EU inspected FDA- or EU inspected Industry: driving force behind ICH/Q7A Q7 = new & alien standard Most producers Q7 & RA compliant At most 1% of 10,000 producers are Q7 & RA compliant No special reputation for counterfeiting Well-known for domestic activities counterfeiting & exportation of counterfeits Few Rogue API manufacturers In China: Out of + 3,000 API manufacturers + 2,000 are Rogue API manufacturers. We don t know how many out of + 10,000 Indian pharmaceutical manufacturers are Rogue API manufacturers. Conclusion: It looks like it could make a VERY big difference *See e.g.: g: pdf and 5

6 Can Compliant APIs compete against Rogue APIs? Rogue APIs are not or little affected by EU Regulations, therefore they: Have lower manufacturing costs: (PricewaterhouseCoopers / IBM Studies: COC = 20-25% of site operating cost minus raw materials*) Have a cost advantage that increases with time (because EU Regulations block many API process improvements and other changes) Conclusion: cuso Compliant APIs cannot compete against Rogue APIs => Many compliant companies are exiting the API business, often step by step, product by product *See e.g.: 6

7 Our focus Re Pharma EFCG/PBC advocacy activities were limited to APIs (now also include excipients) EFCG has argued for more enforcement in API compliance because: Fast changes in the structure of the industry (fragmentation & geography) Combined pressure of globalization and hyper-competition in off-patent medicines EFCG proposed a certifiable standardand enforcement for excipients NB: EFCG feels that with reference to API compliance the enforcement and deterrence levels are inadequate for the 21st century, and as long as enforcement is not revamped the level of risk driven by the API to patients is no longer acceptable 7

8 Our activities since 2004 Advocacy in Brussels and London, later at Member State level, the US Congress and in China Press conferences, articles, position papers, conferences 2007 Q4 - Meetings / Contacts with European Commissioners Kyprianou / Verheugen / Kuneva Barroso Unfortunately not good enough to avoid recalls of non- compliant APIs 8

9 Heparin Monthly export prices from PRC US$/Kg Crude heparin Purified heparin 9

10 Pure Heparin PRC exporters 10 producers make 97% Wide price fluctuation Producers >< Exporters 10

11 PRC Exporters of Pure Heparin to Europe only exporters 17 producers; Producers >< exporters >< CEP holders Wide price fluctuation, and Average price to Europe $1668/kg Average price to North America $1942/kg 11

12 Heparin US, Germany, France, Italy, Denmark, Switzerland and Japan have all pulled heparin products from the market due to the presence of contamination or as a precautionary measure after API links to China were made. TGA website: contamination in samples of heparin distributed in Australia PRC Pure Heparin exports 39 countries 60 ton, US$105m, $1744/kg Correlation with EU traders and producer locations. 12

13 Heparin & monographs Issue highlights once again urgency of: monograph writing considers the new realities of the 21st century pharma business: Globalised and fragmented Majority of APIs / products are off-patent Hyper-competition prompter and better revision of monographs, more cooperation between USP and EDQM to share resources, as a role model for more global engagement, harmonize more efficiently monograph revisions, such that tools are provided to industry to better detect sub-standard APIs and medicinal products That said, the best monograph will not protect us from rogues, fraud and deliberate crime 13

14 Results of our Efforts Written Declaration at the European Parliament Congressional pressure on FDA foreign inspections PRC SFDA / USA FDA deal Commission pursuing urgently new legislation: API compliance enforcement to be rolled into the anti-counterfeit medicines legislation (per public consultation document) Collaborating with the HMA Working Group of Enforcement Officers (WGEO) Collaborating with IMPACT! Working closer with Patients Organisations 14

15 Leadership APIC EU - ICH Q7a becomes law Rogue trader issue identified: 2006 extensive e use of APIs that are USP Verified scheme starts regulatory non-compliant EU Parliament Written Declaration Installation of Task Force on 2007 counterfeit APIs (16 April) US Congress investigates FDA s 2004 foreign inspections capabilities EFCG - Start of advocacy on WHO Rules on APIs increased enforcement to address new reality (globalized WHO / Impact - Recommends fragmented & hyper-competitive elements of anti-counterfeit off-patent medicines) medicines law APIC - No Safe Medicines Without US FDA and PRC SFDA deal Safe Ingredients Position 2008 Paper 24Dec04 EU - Anti-counterfeit legislation process begins 15

16 Next Steps Continued advocacy activities at a global level 3 rd EFCG Pharma Business Conference, Lisbon May, Strategies for Compliant Pharma Sourcing + How to do guides: Criteria for risk assessment How to buy legitimate APIs Certification scheme for Excipients 16

17 Thank you For more information, please contact: Dr. Arnulf Heubner Tel: Mr Tony Scott Tel: This presentation will be found at 17