The European system – Why? Complete single eu market for pharmaceuticals

European Medicine Strategy and Liver Diseases/Hepatitis International Symposium Liver & Drugs 2008 – Viral Hepatitis – The Health Priority in EU, September 5, 2008, Bratislava, Slovak Republic Jan Mazag, CHMP Member, EMEA (London)‏

The European system – Why?

• Complete single EU market for pharmaceuticals

• Protect and promote public and animal health

• Facilitate availability to patients of new medicines

• Same product information for professionals and for patients

• Benefit European R&D pharmaceutical industry

• Platform for discussion of public health issues at European level

The European system – How?

• “One European system: two procedures”

• Centralised procedure
• Mutual recognition and decentralised procedures

• EMEA is focal point of the centralised procedure

• Rapid and EU-wide authorisation after single evaluation

• No price or reimbursement issues

40 years of harmonisation

• 1965 - First Directive set out basic principles

• 1975 - First pharmaceutical testing Directive

• 1981 - Specific veterinary legislation adopted

• 1985 – ‘1992 Single Market’ project launched

• 1993 - Council Regulation No 2309/93 adopted

• 1995 - EMEA officially opens and new European system comes into operation

• 2001 - Commission proposes ‘Review’ package

• 2004 – Part of new legislation comes into force

• 2005 - New legislation came fully into force

A networking decentralised agency

EMEA and its Europartners

• Some 45 national competent authorities (dealing with human and veterinary medicines)‏

• Network of over 4,500 European experts

EMEA and national authorities

• European experts’ network underpins the work of the scientific committees and working parties

• European experts work for EMEA independently of their nominating authority

• Scientific competence is guaranteed by their nominating authority, independence and integrity assured by public declaration of interests

• Services provided to EMEA on basis of a contract (conditions, quality and payment) €60m in 2008

EMEA and EU institutions

• EMEA is a decentralised agency of the EU, not part of the European Commission

• EMEA adopts opinions on basis of scientific criteria, Commission takes decisions based on that opinion

• Commission must fully justify decision when it is not in accordance with EMEA opinion

EMEA – a dynamic agency

• 2001: Orphan medicines

• 2005 & 2008: Extended mandatory scope

• 2005: ‘Biosimilar’ and generic medicines

• 2005: Herbal medicines

• 2007: Paediatric medicines

• 2008/2009: Advanced therapies

EMEA priorities in 2008

• Our core business

• Safety monitoring of medicines for human and veterinary use

• Earlier and improved availability of medicines

• Stimulation of innovation

• The European medicines network

• Transparency, communication and provision of information

• International regulatory activities

Vaccines for preventive use

• Problem of immunogenicity of vaccines

• Effectivity of vaccines

• content of organomercuric preservative mainly used in vaccines (from 1999)‏

HBV actual guidelines

• Guideline on the core SPC for human plasma derived hepatitis –B immunoglobulin for intramuscular use (CHMP/BPWG/4222/02)‏

• Actual from November 2006

• Guideline on the core SPC for human plasma derived hepatitis-B immunoglobulin for intravenous use (CHMP/BPWG/4207/02

• Actual from November 2006

• Coordination role in harmonisation of SPC for products used in

• immunopropfylaxis of HBV in non- immunised patients

HCV Infection – European perspective

• HCV infection is the most common infection causing chronic liver disease.

• Prevalence varies by geographic region (about 0.5% in Northern countries, 2% and higher in Mediterranean countries / Eastern Europe).

• HCV of genotype 1(GT 1) is the predominant genotype.

• 30% (-50%) of HIV-infected patients are co-infected with HCV.

• After about 20 years, around 20–30% of chronic carriers progress to cirrhosis, 5–10% have end stage liver disease and 4–8% die of liver-related causes. In patients with cirrhosis, the 5-year risk of hepatic decompensation is around 15-20% and that of hepatocellular carcinoma around 10%.

• The current standard-of-care (SOC) is pegylated interferon-alpha 2a or 2b and ribavirin.

• With SOC, around 70-85% of patients infected with HCV genotype 2 and 3 achieve SVR after a 6-month treatment course. In contrast, only half of patients infected with HCV genotype 1 and 4 reach SVR despite treatment for one year.

Medicinal products for treatment of Hepatitis (1/2)‏

Medicinal products for treatment of Hepatitis (2/2)‏

EMEA/CHMP Guidelines

• Clinical Evaluation of Medicinal Products intended for Treatment of Hepatitis B (CPMP/EWP/6172/03)‏

• In effect since Sep 2006

• Clinical Evaluation of Direct Acting Antiviral Agents intended for Treatment of Chronic Hepatitis C (CHMP/EWP/30039/08)‏

• Release for consultation Apr 2008

Draft HCV Guideline (1/2)‏

• Scope

• Guidance on the design of exploratory and confirmatory clinical studies for the evaluation of direct-acting anti-HCV compounds as add-on to SOC in different target populations.

• Specifically addressing the constraints caused by the high mutation rate of HCV.

• Focused on direct-acting anti-HCV compounds.

Draft HCV Guideline (2/2)‏

Published Draft

• http://www.emea.europa.eu/pdfs/human/ewp/3003908en.pdf