All European sources

 
Title Link
Pediatric Trials and Intellectual Property Incentives in the EU - A Report by Europe Economics for Merck Sharp and Dohme (Europe) Inc. - May 2001 - (73 pages) http://www.eer.co.uk/download/eepaedia.pdf 
Commission Regulation (EC) No 240/96 of 31 January 1996 on the application of Article 85 (3) of the Treaty to certain categories of technology transfer agreements http://europa.eu.int/eur-lex/en/lif/dat/1996/en_396R0240.html 
Commission evaluation report on the transfer of technology block exemption regulation n° 240/96 (44 pages)
Technology transfer agreements under article 81
http://www.europa.eu.int/comm/competition/antitrust/technology_transfer/en.pdf 
J.C. Dumon, M. Sneyers et W. Moens - Report: First Gene Therapy Related Death - Belgian Biosafety Council - 2000 - (20 pages) http://biosafety.ihe.be/GT/regulatory/RapportEN27_06_2001.pdf 
Gene Therapy Advisory Committee - Health Departments of the United Kingdom - 1999 - (58 pages) http://www.doh.gov.uk/genetics/gtac6.pdf 
Alexander Kotok - The history of homeopathy in the Russian Empire until World War I, as compared with other European countries and the USA: similarities and discrepancies http://www.homeoint.org/books4/kotok/index.htm 
The Danish Council of Ehtics - Genetic investigation of Healthy Subjects - Report on Presymptomatic Gene Diagnosis http://www.etiskraad.dk/publikationer/genetic/ren.htm 
HGC and the Human Fertilisation Embryology Authority (HFEA) - Outcome of the Public Consultation on Preimplantation Genetic Diagnosis - (33 pages) http://www.hgc.gov.uk/business_publications_pgdoutcome.pdf 
Human Genetics Commission - First Annual Report- (58 pages) http://www.hgc.gov.uk/business_publications_annualreport_first.pdf 
ICSU - International Council for Science - home page - "a non-governmental organization, founded in 1931 to bring together natural scientists in international scientific endeavour http://www.icsu.org/ 
EFGCP - International Guidelines on Bioethics Informal Listing of Selected International Codes, Declarations, Guidelines, etc. on Medical Ethics/Bioethics/Health Care Ethics/Human Rights Aspects of Health - 3rd Edition - (18 pages) http://www.efgcp.org/webdocs/international.pdf 
EFGCP - Optional Guideline for Good Clinical Practice Compliance and Quality Systems Auditing In conformity with the Note for Guidance on GCP CPMP/ICH/135/95 (ICH GCP) http://www.efgcp.org/webdocs/engage.pdf 
EFGCP - Guidelines and Recommendations for European Ethics Committees - (18 pages) http://www.efgcp.org/webdocs/efgcprecommendation.pdf   
EFGCP - Audit Working Party The handling of Case Report Form (CRF) at an investigational site http://www.efgcp.org/webdocs/handling_of_CRF.pdf 
EFGCP - Audit Working Party Protocol Compliance - (6 pages) http://www.efgcp.org/webdocs/protocol_compliance.pdf 
EFGCP - Records Management and Archiving Working Party Guidelines for Retention of Clinical Trial Records at Investigator Study Sites - / pages) http://www.efgcp.org/webdocs/guidelines_for_retention.pdf 
EU - Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use http://www.efgcp.org/webdocs/guidelines_for_retention.pdf 
SIDCDER - home page - "an independent international cooperative project designed to facilitate the development of the ethical review of biomedical research" http://www.sidcer.net/ 
The British Medical Journal - home page - access to full-text papers http://bmj.com/ 
The Lancet - home page - http://www.thelancet.com/journal 
Anna Merino-Castelló - The impact of the reference price system on the pharmaceutical market: a theoretical approach- February, 2000 - (32 pages) http://www.econ.upf.es/deehome/what/wpapers/postscripts/524.pdf  
Andreas Pyka and Paolo Saviotti - Innovation Networks in the Biotechnology-Based Sectors - July 2001 - (35 pages) http://www.wiwi.uni-augsburg.de/vwl/institut/paper/205.pdf 
Thomas Aronsson Mats A. Bergman and Niklas Rudholm - The Impact of Generic Competition on Brand Name Market Shares: Evidence from Micro Data- December 1997 - (22 pages) http://swopec.hhs.se/hastef/papers/hastef0274.pdf 
Guillem López-Casasnovas Jaume Puig-Junoy - Review of the Literature on Reference Pricing - April 14th, 2000 - (47 pages) http://www.econ.upf.es/deehome/what/wpapers/postscripts/362.pdf 
United Kingdom - Advice to Research Ethics Committees - Points to consider in ethical review of medical research involving genetic testing - October 1998 - (13 pages) http://www.doh.gov.uk/pub/docs/doh/recrev3.pdf 
EMEA - Fees payable to the EMEA - Human Medicinal Products http://www.emea.eu.int/htms/general/admin/fees/feesh.htm  http://www.emea.eu.int/pdfs/general/direct/fees/711499en.pdf 
EMEA - EMEA/17424/01 Position Statement on the Use of Placebo in Clinical Trials with regard to the Revised Declaration of Helsinki - June 2001 http://www.emea.eu.int/pdfs/human/press/pos/1742401en.pdf 
EMEA - Market Authorisation Withdrawals (Also includes Suspensions of MA) http://www.emea.eu.int/htms/human/withdraw/withdraw.htm 
EMEA - EMEA/H/30313/98 Revision 1 Procedure for Notifications of Parallel Distribution of Centrally Authorised Medicinal Products - (page 4) http://www.emea.eu.int/pdfs/human/parallel/3031398en.pdf 
EMEA - CPMP Opinions on approval or refusal of marketing authorizations http://www.emea.eu.int/htms/human/opinion/opinion.htm 
EMEA - CPMP/EWP/462/95 Note for Guidance on Clinical Investigation of Medicinal Products in Children (CPMP adopted March 97) - (12 pages) http://www.emea.eu.int/pdfs/human/ewp/046295en.pdf 
EMEA - CPMP/EWP/240/95 Note for Guidance on Fixed Combination Medicinal Products (CPMP adopted April. 96) - (5 pages) http://www.emea.eu.int/pdfs/human/ewp/024095en.pdf 
Centre for Evidence-Based Medicine - home page http://cebm.jr2.ox.ac.uk/ 
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices http://europa.eu.int/eur-lex/en/lif/dat/1993/en_393L0042.html 
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices http://europa.eu.int/eur-lex/en/lif/dat/1990/en_390L0385.html 
Mark P. Mobach & Jos J. van der Werf & T.(Dick) F.J. Tromp - APOM-project: an investigation of pharmacy organization and management - (22 pages) http://www.ub.rug.nl/eldoc/som/97A07/97a07.pdf 
Health Care Inspectorate of the Netherlands - Marketing plans for medicinal products available on prescription only: the current situation - The Hague, July 2001, second revised edition http://www.healthyskepticism.org/editions/2002/IN04.htm 
HAI (Health Action International) Europe - Providing prescription medicine information to consumers: Is there a role for direct-to-consumer promotion? Symposium Report- 2002 - (60 pages) http://www.haiweb.org/campaign/DTCA/2002_symposium_report.pdf 
Mark Thomas - Drug Donations:
corporate charity or taxpayer subsidy? - (18 pages)
http://www.waronwant.org/dd-report.pdf 
C-318/90 Case decision of June 3, 1992 Hauptzollamt Mannheim / Boehringer Rec.1992,p.I-3495) http://www.curia.eu.int/common/recdoc/indexaz/en/c2.htm 
C-285/91 - Judgment of 18/02/1993, Merck / Hauptzollamt Hamburg-Jonas (Rec.1993,p.I-729 http://www.curia.eu.int/common/recdoc/indexaz/en/c2.htm#C-427/93 
High Level Group Set to Improve Equality of Access to New Medicines Across EU NEWS RELEASE Innovative Medicines and the EU Citizen – Swedish Session - (3 pages) http://dg3.eudra.org/F3/g10/docs/g10w_250102_2.pdf 
C-427/93, C-429/93 and C-436/93 - Judgment of the Court of 11 July 1996. Bristol-Myers Squibb v Paranova A/S and C. H. Boehringer - Repackaging of trade-marked products. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
European industrial relations observatory on-line - Le stress lié au travail et les relations industrielles http://www.eiro.eurofound.ie/print/2001/11/study/TN0111150S.html 
Nuffield Council on Bioethics - Discussion Paper: The ethics of clinical research in developing countries - November 2001 - (36 pages) http://www.nuffieldbioethics.org/filelibrary/pdf/clinicaldiscuss1.pdf 
Nuffield Council on Bioethics - Genetic Screening Ethical Issues - December 1993 - (130 pages) http://www.nuffieldbioethics.org/filelibrary/pdf/genetic_screening.pdf 
Nuffield Council on Bioethics - Mental disorders and genetics : the ethical context - September 1998 - (127 pages) http://www.nuffieldbioethics.org/filelibrary/pdf/mentaldisorders2.pdf 
Nuffield Council on Bioethics - Stem Cell Therapy: the ethical issues a discussion paper - November 2001 - (20 pages) http://www.nuffieldbioethics.org/filelibrary/doc/stem_cell_therapy2.doc 
Nuffield Council on Bioethics - Animal-to-Human Transplants the ethics of xenotransplantation - March 1996 - (168 pages) http://www.nuffieldbioethics.org/filelibrary/pdf/xenotransplantation.pdf 
Nuffield Council on Bioethics - Report: Human Tissue: Ethical and Legal Issues.Published: April 1995 - (182 pages) http://www.nuffieldbioethics.org/filelibrary/pdf/human_tissue.pdf 
Nuffield Council on Bioethics - Annual Report: Annual Report 2000 - (21 pages) http://www.nuffieldbioethics.org/filelibrary/pdf/ncob_annual_report_2000.pdf 
Richard Cookson - The Role of Industry in Evaluation of Health Interventions - (20 pages) http://www.lse.ac.uk/Depts/lsehsc/pdf_files/industry.pdf  
Julian Le Grand. - The Provision of Health Care: Is The Public Sector Ethically Superior To The Private Sector? (21 pages) http://www.lse.ac.uk/Depts/lsehsc/pdf_files/DP1.pdf 
Adam Oliver - The End of The Beginning: Eliciting Cardinal Values For Health States - (26 pages) http://www.lse.ac.uk/Depts/lsehsc/pdf_files/dp2oliver.pdf 
Chrisanthi Avgerou, Tony Cornford and Elias Mossialos - Drug Use Information Systems: A European Perspective, August 1995.- (26 pages) http://www.lse.ac.uk/Depts/lsehsc/papers/Discussion_Papers/dp2.pdf 
List of LSE publications on healthcare http://www.lse.ac.uk/Depts/lsehsc/discussionpapers.htm 
Database of Abstracts of Reviews of Effectiveness (DARE) - at the University of York http://agatha.york.ac.uk/darehp.htm 
NHS Economic Evaluation Database (NHS EED) - at the University of York http://agatha.york.ac.uk/nhsdhp.htm 
Pharmaceutical Industry Competitiveness Task Force - Final Report – March 2001 - (95 pages) http://www.doh.gov.uk/pictf/pictf.pdf 
Jean Lang and Susan C. Wood - Development of Orphan Vaccines: An Industry Perspective - (8 pages) http://www.cdc.gov/ncidod/eid/vol5no6/pdf/lang.pdf 
Judgment of 23/04/2002, Merck, Sharp & Dohme - Case C-443/99.- Exhaustion of the rights conferred by the trade mark http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of 23/04/2002, Boehringer Ingelheim and others - C-143/00 - Exhaustion of the rights conferred by the trade mark http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Pharmaceuticals in the European Union - booklet - (31 pages) http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/brochurenov99.pdf 
Anthony Leonard - The European Approach to Inventive Step in Pharmaceutical Patents http://www2.ari.net./foley/leonard.html 
Legal protection of biotechnical inventions: Frequently Asked questions on scope and objectives of the EU Directive (98/44) http://europa.eu.int/comm/internal_market/en/indprop/invent/2k-39.htm 
Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products http://pharmacos.eudra.org/F2/eudralex/vol-5/pdfs-en/921768en.pdf 
Draft Guidance on the acceptability of trade names for medicinal products processed through the centralized procedure - 2002 - (5 pages) http://www.emea.eu.int/pdfs/human/regaffair/032898en.pdf 
Procedure on the granting of marketing authorisations by central and Eastern European Countries for medicinal products for human use - December 1999 - (18 pages) http://www.il.waw.pl/centralised_procedure.pdf 
Note for Guidance on Specifications: test procedures and acceptance criteria for biotechnological/biological products - (17 pages) http://www.emea.eu.int/pdfs/human/ich/036596en.pdf 
Note for Guidance on Specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products - (19 pages) http://www.emea.eu.int/pdfs/human/qwp/282000en.pdf 
EMA - Annual Report 2001 - (72 pages) http://www.emea.eu.int/pdfs/general/direct/emeaar/005201en.pdf 
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf 
Peter Drahos - The Universality of Intellectual Property Rights - Origins and Development - (36 pages) http://www.wipo.org/globalissues/events/1998/humanrights/papers/pdf/drahos.pdf 
Proposal for a Regulation and Directive - laying down Community procedures for the authorisation and supervision of medicinal products for human use - November 2001 - (200 pages) http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf 
Panos Kanavos - Overview of Pharmaceutical Pricing and Reimbursement Regulation in Europe - LSE Health and Social Care - (31 pages) http://pharmacos.eudra.org/F3/g10/docs/synthesis.pdf 
EurActiv - Health and Pharma - list of useful hyperlink references http://www.euractiv.com/cgi-bin/cgint.exe/886449-533?targ=5&11&1011=fochh 
National Consultative Ethics Committee for Health and Life Sciences (CCNE) France - Technical progress, health and societal models : the ethical dimension of collective choices N°57 - March 20, 1998 - (47 pages) http://www.ccne-ethique.org/english/pdf/avis057.pdf 
National Consultative Ethics Committee for Health and Life Sciences (CCNE) - Opinion on the preliminary draft revision of the laws on bioethics N°67 - January 18, 2001 - (19 pages) http://www.ccne-ethique.org/english/pdf/avis067.pdf 
CCNE N°064 Opinion on a preliminary draft law incorporating transposition into the Code of intellectual property, of a European Parliament and Council Directive 98/44/CE, dated July 6, 1998, on the legal protection of biotechnological inventions http://www.ccne-ethique.org/english/pdf/avis064.pdf 
Communication from the European Communities and their member states to the trips council concept paper relating to paragraph 6 of the Doha declaration on the trips agreement and public health - (8 pages) http://trade-info.cec.eu.int/europa/2001newround/050-02-rev.pdf 
Working document tiered pricing for medicines exported to developing countries, measures to prevent their re-importation into the EC market and tariffs in developing countries 22 April, 2002 http://europa.eu.int/comm/trade/pdf/med_wd.pdf 
European Generic medicines Association List of publications http://www.egagenerics.com/facts_figures/intellectual_property/intellectual_property.htm 
Council Directive - of 24 November 1986 - 86/609/EEC - on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes http://europa.eu.int/comm/food/fs/aw/aw_legislation/scientific/86-609-eec_en.pdf 
Council Directive of 7June 1988 on the inspection and verification of Good Laboratory Practice (GLP) (88/320/EEC) http://europa.eu.int/eur-lex/en/consleg/pdf/1988/en_1988L0320_do_001.pdf 
Governance arrangements for NHS Research Ethics Committees - July 2001 - (35 pages) http://www.doh.gov.uk/research/documents/gafrec.pdf 
South West Local Research Ethics Committees Common Application Form Guidance Notes - August 2001 - (19 pages) http://www.doh.gov.uk/research/swro/rd/ethics/ethforms/ethguid.pdf 
Iain Chalmers - Current Controlled Trials: an opportunity to help improve the quality of clinical research - (6 pages) http://cvm.controlled-trials.com/content/pdf/cvm-1-1-003.pdf 
Proceedings of the 5th European Conference of National Ethics Committees (COMETH) 4-5 September 2000, - Strasbourg - (81 pages) http://www.legal.coe.int/bioethics/gb/pdf/5e_conference.pdf 
Generics - home page - "consultancy, IP exploitation, and technology investment" http://www.generics.co.uk 
Ashish Arora, Alfonso Gambardella,Fabio Pammolli, Massimo Riccaboni, The Nature and the Extent of the Market for Technology in Biopharmaceuticals, EPRIS, - December 2000 - (42 pages) http://www.unisi.it/epris/abstract/biotec.doc 
Web site of the European Agency for the Evaluation of Medicinal Products (EMEA) http://www.emea.eu.int/# 
EMEA Web Site for Human Medicines http://www.emea.eu.int/index/indexh1.htm 
EMEA General Information for Sponsors of Orphan Medicinal Products (EMEA/4795/00) http://www.emea.eu.int/pdfs/human/comp/479500en.p 
European Commission Enterprise DG http://pharmacos.eudra.org 
European Commission, Enterprise Directorate-General, G10 Medicines High Level Group on Innovation and Provision of Medicines, Single market, implementation and legislation for consumer goods, Consultation Paper, p 20 http://pharmacos.eudra.org/F3/g10/docs/g10an1.pdf 
Information on the high level group on Innovation and the Provision of Medicines http://pharmacos.eudra.org/F3/g10/p2.htm 
Report from the Commission on the experience acquired as a result of the operation of the procedures for granting marketing
authorisations for medicinal products laid down in Regulation (EEC) N° 2309/93, 2001, (p 33)
http://pharmacos.eudra.org/F2/review/doc/reviewrapport/rap_fv_en.pdf 
European Commission, Enterprise Directorate-General, Pharmaceutical Legislation Review 2001, Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations, (p 77) http://pharmacos.eudra.org/F2/review/doc/2codehumain_fr_18-7-2001.pdf 
Reform of EU Pharmaceutical Legislation, Brussels, 18 July 2001, MEMO/01/267 http://pharmacos.eudra.org/F2/review/doc/brief_m01_267_en.pdf 
List of directives and regulations of the European Union regarding proprietary medicinal products http://europa.eu.int/eur-lex/en/lif/reg/en_register_1530.html 
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products http://europa.eu.int/eur-lex/en/lif/dat/1965/en_3 
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products http://europa.eu.int/eur-lex/en/lif/dat/1975/en_3 
Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products http://europa.eu.int/eur-lex/en/lif/dat/1975/en_3 
Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products http://europa.eu.int/eur-lex/en/lif/dat/1978/en_3 
Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens http://europa.eu.int/eur-lex/en/lif/dat/1989/en_3 
Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials http://europa.eu.int/eur-lex/en/lif/dat/2001/en_3 
Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 http://europa.eu.int/eur-lex/en/lif/dat/1996/en_3 
Maureen McKelvey* and Luigi Orsenigo - Pharmaceuticals as a Sectoral Innovation System - November 2001 - (74 pages) http://www.cespri.uni-bocconi.it/essy/mckelors.PDF 
Nicola Lacetera and Luigi Orsenigo - Political regimes, technological regimes and innovation in the evolution of the pharmaceutical industry in the USA and in Europe - CEPRIS - March 2001 - (rough draft) - (59 pages) http://www.unisi.it/ricerca/prog/epris/abstract/pdf/Lacetera-Orsenigo-Baltimore2.PDF 
CESPRI - Centre for Research on Innovation and Internationalisation - home page http://www.cespri.uni-bocconi.it/ 
ERPIS - home page - "The main objective of EPRIS is to develop a comprehensive analysis of the structure and evolution of the European Pharmaceutical Regulation and Innovation Systems" http://www.unisi.it/ricerca/prog/epris/index.htm 
OHE - The Office of Health Economics - home page http://www.ohe.org/ 
BioMedNet - home page - "BioMedNet is the website for biological medical researchers" http://www.bmn.com/ 
European Commission - XXIXth Report on Competition Policy 1999 - (pages 400) http://europa.eu.int/comm/competition/annual_reports/1999 /en.pdf   
The European Group on Ethics in Science and new Technologies - - Adoption of an Opinion on Ethical Aspects of Stem Cell Research and Use- January 2001 - (230 pages) http://www.europa.eu.int/comm/european_group_ethics/docs/dp15.pdf 
The European Group on Ethics in Science and New Technologies to the European Commission - General Report on its activities 1998-2000 - (163 pages) http://www.europa.eu.int/comm/european_group_ethics/docs/rap_en.pdf 
European Commission Directorate - General XII Science, Research and Development- Biotechnology R&D in Europe - 1996 - (37 pages) http://europa.eu.int/comm/research/biotech/national.pdf 
European Commission, Directorate - General XII Science, Research Development - Coordination of Structural Biology in Europe, National EC and Industry Joint Efforts - (156 pages) http://europa.eu.int/comm/research/biotech/structur.pdf 
COMMUNICATION FROM THE COMMISSION TOWARDS A STRATEGIC VISION OF LIFE SCIENCES AND BIOTECHNOLOGY:
CONSULTATION DOCUMENT - Brussels, September 4, 2001 - (32 pages)
http://europa.eu.int/comm/biotechnology/pdf/doc_en.pdf 
European Parliament: Temporary Committee on Human Genetics and Other New Technologies in Modern Medicine - Report on the ethical, legal, economic and social implications of human genetics - November 8, 2001 - http://www.europarl.eu.int/comparl/tempcom/genetics/rapfin/rapfin_en.doc 
European Committee for Standardization - CEN - home page http://www.cenorm.be/ 
PERF - Pan European Regulatory Forum - home page - "The ultimate aim of this programme is the transposition of all technical regulations and European technical acts into the national legislation of central and eastern European countries (CEECs)" http://perf.eudra.org/ 
Herbal medicinal products in the European Union - Study carried out on behalf of the European Commission - (149 pages) http://pharmacos.eudra.org/F2/pharmacos/docs/doc99/Herbal%20Medecines%20EN.pdf 
NERA - Policy Relating to Generic Medicines in the OECD - Study carried out on behalf of the European Commission - (237 pages) http://pharmacos.eudra.org/F2/pharmacos/docs/nerareport.pdf 
Impact of electronic commerce on the European Pharmaceutical Sector - An overview by Ashurst Morris Crisp and Executive Perspective S.A.- November 1998 - (84 pages) http://pharmacos.eudra.org/F2/smarket/pdf/EU-Pharma-Final.pdf 
European Commission - Pharmaceuticals in the European Union - Information brochure - (42 pages) http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/pharmaeu.pdf 
European DG Enterprise - Inventory of Community and national incentive measures to aid the research, marketing, development and availability of orphan medicinal products - (17 pages) http://pharmacos.eudra.org/F2/orphanmp/doc/inventory/Inventory-en.pdf 
Draft Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another, revision December 2000 http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2000/dec/format-content-rev3.pdf 
COMMISSION REGULATION (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts http://pharmacos.eudra.org/F2/orphanmp/doc/rev1/en1.pdf 
REPORT on the communication from the Commission on the Single Market in Pharmaceuticals (COM(98)0588 - C4-0127/99) - April 21, 1999 - (18 pages) http://pharmacos.eudra.org/F2/smarket/pdf/cemaipen.pdf 
Third Round Table "Completing the Single Pharmaceutical Market" - December 7, 1998, (77 pages) http://pharmacos.eudra.org/F2/smarket/pdf/Roundt3.pdf 
Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use http://www.europa.eu.int/eur-lex/en/lif/dat/2001/en_301L0020.html  
European Commission, Provisions of a directive on traditional medicinal products http://www.mca.gov.uk/ourwork/licensingmeds/herbalmeds/echerb.pdf 
The rules governing medicinal products in the European Union - Pharmaceutical legislation- Medicinal products for human use- Volume I -1998 - (294 pages) http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol1/vol1en.pdf 
Notice to Applicants Volume 2A - Procedures for marketing autorisation http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2aen.pdf 
Notice to Applicants - Volume 2B - Medicinal products for human use - Presentation and content of the dossier - 1998 - (206 pages) http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2ben.pdf 
Guidelines - Volume 3A - Medicinal products for human use - Quality and biotechnology - 1998 - (417 pages) http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/vol3aen.pdf 
Guidelines - Volume 3B - Medicinal products for human use - Safety, environment and information - 1998 - (240 pages) http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3ben.pdf 
Guidelines - Volume 3C - Medicinal products for human use - Efficacy - 1998 - (402 pages) http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3cen.pdf 
Volume 4 - Good manufacturing practices - Medicinal products for human and veterinary use - (153 pages) http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol4/vol4en.pdf 
European Commission - Revision of Annex 14 to the EU Guide to Good Manufacturing Practice - Manufacture of medicinal products1 derived from human blood or human plasma - (7 pages) http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/gmpan14_en.pdf 
The European Observatory on Health Care Systems - home page - "supports and promotes evidence-based health policy-making through comprehensive and rigorous analysis of the dynamics of health care systems in Europe" http://www.euro.who.int/observatory/TopPage   
Virology Education - home page - "Our field of interest is the area of Virology, specifically HIV-AIDS care" http://www.virology-education.com 
Guilio Bottazzi, Giovanni Dosi, Marco Lippi, Fabio Pammolli, Massimo Riccaboni Innovation and Corporate Growth in the Evolution of the Drug Industry, EPRIS, July 2000 http://www.unisi.it/epris/abstract/pdf/geroski.pdf 
Leah Brannon, Regulating Drug Promotion on the Internet, 54 Food and Drug Law Journal 599-622 (1999), http://www.fdli.org/pubs/Journal%20Online/54_4/art8.pdf 
Stefano Breschi, Francesco Lissoni and Luigi Orsenigo, Success and failure in the development of biotechnology clusters: the case of Lombardy http://nt-notes.liuc.it/ricerca/IstitutoEconomia.nsf/c6d95ba0f57aa4cac12567b0005a08ba/a13ef9d5ce2843aec1256a14006878de/$FILE/Stuttbook.PDF 
S. Casper and H. Kettler, National Institutional Frameworks and the Hybridization of Entrepreneurial Business Models: The German and UK Biotechnology Sectors http://www.unisi.it/epris/abstract/Casper_Kettler.doc 
T.A.B. Corley, The British Pharmaceutical Industry Since 1851 - (33 pages) http://www.rdg.ac.uk/Econ/Econ/workingpapers/emdp404.pdf 
Manfred Fleischer, Sabine Kelm, Deborah Palm, Regulation and Innovation in the Chemical Industry, L. Delgado (editor), October 2000, Institute for Prospective Technological Studies, http://www.teesvalley-jsu.gov.uk/dicidauk/keyissues/chemstrat/eur19735en.pdf 
Alfonso Gambardella, Luigi Orsenigo, Fabio Pammolli, Global Competitiveness in Pharmaceuticals, A European Perspective, , November 2000, report prepared for the Directorate General Enterprise of the European Commission, http://www.unisi.it/epris/abstract/pdf/pharma.pdf 
Lucas Bergkamp - Allocating Unknown Risk : Liability for Environmental Damages Caused by Deliberately Released Genetically Modified Organisms - Brussels - 2000 - (32 pages) http://papers.ssrn.com/sol3/delivery.cfm/000411502.pdf?abstractid=223068 
Judgment of the Court (Fifth Chamber) of 30 November 1983 - against Leendert van Bennekom - Case 227/82 - Concept of "Medicinal products" http://curia.eu.int/common/recdoc/indexaz/en/c1.htm 
Judgment of the Court of 7 February 1984. Duphar BV - Case 238/82 - Health-care scheme - Compatibility with the Treaty of restrictions on access to certain medicinal preparations http://curia.eu.int/common/recdoc/indexaz/en/c1.htm 
Judgment of the Court (Fifth Chamber) of 21 March 1991 - against Jean-Marie Delattre -Case C-369/88. - Concepts of "disease" or "illness" and "medicinal product" http://curia.eu.int/common/recdoc/indexaz/en/c1.htm 
Judgment of the Court of 31 October 1974 - Centrafarm BV et Adriaan de Peijper v Sterling Drug Inc. - Case 15-74 - Reference for a preliminary ruling: Hoge Raad - Netherlands - Parallel patents. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm 
Judgment of the Court of 20 May 1976 - Adriaan de Peijper, Managing Director of Centrafarm BV - Case 104-75
Reference for a preliminary ruling: Kantongerecht Rotterdam - Netherlands.
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm 
Judgment of the Court of 10 October 1978 - Centrafarm BV v American Home Products Corporation - Case 3/78- Reference for a preliminary ruling: Arrondissementsrechtbank Rotterdam - Netherlands.
Serenid - Seresta.
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm 
Judgment of the Court of 14 July 1981 - Merck & Co. Inc. v Stephar BV and Petrus Stephanus Exler. - Case 187/80 - Reference for a preliminary ruling: Arrondissementsrechtbank Rotterdam - Netherlands. - Patents - Pharmaceutical products. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm 
Judgment of the Court of 18 May 1989 - The Queen v Royal Pharmaceutical Society of Great Britain, ex parte Association of Pharmaceutical Importers and others - Parallel imports - - Trade-mark law - Joined cases 266 and 267/87. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87  
Judgment of the Court of 23 May 1978 - Hoffmann-La Roche & Co. AG v Centrafarm - Case 102/77 - Re-packaging of trade-marked goods. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court of 9 July 1985 - Pharmon BV v Hoechst AG. - Case 19/84 - Patents - Extent of protection - Exhaustion of patent rights where a compulsory licence has been granted in respect of a parallel patent. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court of 3 March 1988 - Allen and Hanburys Ltd v Generics (UK) Ltd. - Case 434/85 - Patents endorsed 'Licences of right' - Scope of protection - Compulsory licence under a patent. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court of 29 November 1983 - Roussel Laboratoria BV - Case 181/82 - Regulation of prices for imported medicines. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court of 9 June 1988 - Commission of the European Communities v Italian Republic - Case 56/87 - National rules governing the prices of pharmaceutical products. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court of 19 March 1991 - Commission of the European Communities v Kingdom of Belgium - Case C-249/88 - National legislation on the price of pharmaceutical products - System of programme contracts. http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court of 28 February 1984 - Commission of the European Communities v Federal Republic of Germany - http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court (Fifth Chamber) of 27 May 1986. Société coopérative - Cophalux v Minister for Health - Rules governing the importation and marketing of medicinal products - Joined cases 87 and 88/85 http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of the Court (Third Chamber) of 7 March 1989 - Heinz Schumacher v Hauptzollamt Frankfurt am Main-Ost - Case 215/87
Importation of medicinal preparations
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 
Judgment of March 21, 1991 - against Monteil and Samanni - Case 60/89 http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of 16/04/1991, Upjohn / Farzoo - Case 112/89 http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of May 20, 1992 - Commission / Germany - Case 290/90 http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of December 12, 1993 - Pierrel and others / Ministero della Sanità - Case 83/92 http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of October 5, 1995 - The Queen / Licensing Authority of the Department of Health and Norgine, ex parte Scotia Pharmaceuticals - Case C-440/93 http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court (Fifth Chamber) of 3 December 1998 - The Queen v The Licensing Authority established by the Medicines Act 1968 - Case C-368/96 - Marketing authorisation - Abridged procedure - Essentially similar products. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 22 June 1994 - IHT Internationale Heiztechnik GmbH -Case C-9/93 - Splitting of a trade mark as a result of a voluntary assignment - - Free movement of goods. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court (Fifth Chamber) of 1 July 1993 - Eurim-Pharm GmbH v Bundesgesundheitsamt. - Case C-207/91.
- Parallel imports of pharmaceutical products
http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 12 November 1996 - The Queen v The Medicines Control Agency - Case C-201/94 - Parallel imports - Direct effect of Directive 65/65/EEC - Marketing authorization. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 11 July 1996 - Eurim-Pharm Arzneimittel GmbH v Beiersdorf AG - Case C-71/94 - Repackaging of trade-marked products http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 11 July 1996 - MPA Pharma GmbH v Rhône-Poulenc Pharma GmbH - Case C-232/94- Repackaging of trade-marked products http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 27 October 1992 - Generics (UK) Ltd and Harris Pharmaceuticals Ltd v Smith Kline & French Laboratories Ltd - Case C-191/90 - Compulsory patent licences http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 5 December 1996 - Merck & Co. Inc. -Joined cases C-267/95 and C-268/95 - Parallel imports of unpatentable pharmaceuticals - Spain and Portugal - http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 9 July 1997 - Generics BV v Smith Kline & French Laboratories Ltd. - Case C-316/95- Patent - Registration of medicinal products - Infringement. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 28 April 1998 - Raymond Kohll v Union des caisses de maladie - Case C-158/96- Reimbursement of medical expenses incurred in another Member State http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 28 April 1998 - Raymond Kohll v Union des caisses de maladie - Case C-158/96- Reimbursement of medical expenses incurred in another Member State http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 28 April 1998 - Nicolas Decker v Caisse de maladie des employés privés- Case C-120/95 - Reimbursement of medical expenses incurred in another Member State http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court (Fifth Chamber) of 10 November 1994 - Lucien Ortscheit GmbH v Eurim-Pharm Arzneimittel GmbH.-Case C-320/93.
- Importation of medicines not agreed by the importing State - Prohibition of advertising
http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 8 April 1992 - Commission of the European Communities v Federal Republic of Germany -Case C-62/90 - Importation of medicinal products y private individuals - Limits. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 8 June 1993 - Commission of the European Communities v Kingdom of Belgium - Case C-373/92 - Obligation to carry out examinations which have already been performed in the Member State of origin. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court (Sixth Chamber) of 23 January 1997 - Biogen Inc. v Smithkline Beecham Biologicals SA - Supplementary protection certificate for medicinal products - Refusal by the holder of the marketing authorization- Case C-181/95 http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court (First Chamber) of 15 May 1997 - Bioforce GmbH v Oberfinanzdirektion München - Case C-405/95 - Common customs tariff - Heading 3004 - Echinacea - Medicament. http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
Judgment of the Court of 20 November 2001 - Zino Davidoff SA v A & G Imports Ltd and Levi Strauss & Co - Exhaustion of the rights conferred by a trade mark - Joined cases C-414/99 to C-416/99 http://curia.eu.int/common/recdoc/indexaz/en/c2.htm 
EEC Council: Regulation No 17: First Regulation implementing Articles 85 and 86 of the Treaty http://europa.eu.int/eur-lex/en/lif/dat/1962/en_362R0017.html 
Regulation No 19/65/EEC of 2 March of the Council on application of Article 85 (3) of the Treaty to certain categories of agreements and concerted practices http://europa.eu.int/eur-lex/en/lif/dat/1965/en_365R0019.html 
Regulation (EEC) No 2821/71 of the Council of 20 December 1971 on application of Article 85 (3) of the Treaty to categories of agreements, decisions and concerted practices http://europa.eu.int/eur-lex/en/lif/dat/1971/en_371R2821.html 
Commission Regulation (EC) No 2790/1999 of 22 December 1999 on the application of Article 81(3) of the Treaty to categories of vertical agreements and concerted practices http://europa.eu.int/eur-lex/en/lif/dat/1999/en_399R2790.html 
Commission Regulation (EC) No 2659/2000 of 29 November 2000 on the application of Article 81(3) of the Treaty to categories of research and development agreements (Text with EEA relevance) http://europa.eu.int/eur-lex/en/lif/dat/2000/en_300R2659.html 
76/642/EEC: Commission Decision of 9 June 1976 relating to a proceeding under Article 86 of the Treaty establishing the European Economic Community (IV/29.020 - Vitamins) http://europa.eu.int/eur-lex/en/lif/dat/1976/en_376D0642.html 
Community legislation in force on Foodstuffs http://europa.eu.int/eur-lex/en/lif/reg/en_register_133014.html 
Community legislation in force on cosmetics http://europa.eu.int/eur-lex/en/lif/reg/en_register_133016.html 
Community legislation in force on health protection http://europa.eu.int/eur-lex/en/lif/reg/en_register_1530.html 
European initiatives for smoking prevention http://europa.eu.int/comm/health/ph/programmes/tobacco/index_en.htm 
Proposal for a Directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products - May 30, 2001 http://europa.eu.int/comm/health/ph/programmes/tobacco/comm283_en.pdf  
European Union information on the safety of blood http://europa.eu.int/comm/health/ph/others/safety_blood/index_en.htm 
The Joint Research Centre - home page - "the European Union’s scientific and technical research laboratory" http://www.jrc.cec.eu.int/index.asp 
A European Parliament vote against a ban on human cloning has cleared the way for EU investment in stem cell research over the next five years. http://europa.eu.int/comm/research/headlines.html#01 
Innovation in Europe: Research and Results - Medicine and health http://europa.eu.int/comm/research/success/en/med/succ-med.html 
Green Paper on the Review of Council Regulation (EEC) No 4064/89
(presented by the Commission) - December 11, 2001 - (59 pages)
http://europa.eu.int/comm/research/success/en/med/succ-med.html 
Proposal for a Council Regulation amending Regulation No 19/65/EEC on the application of Article 85(3) of the Treaty to certain categories of agreements and concerted practices- September 30, 1998 http://www.europa.eu.int/comm/competition/antitrust/com1998546_en.pdf 
Case No COMP/M. 1806 - Astra Zeneca / Novartis - Regulation EEC No 4064/89 - merger procedure - (139 pages) http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1806_en.pdf 
Merger Procedure Abbott / BASF - Case No COMP/M.2312 -REGULATION (EEC) No 4064/89 http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m2312_en.pdf 
Merger Procedure Pfizer / Warner Lambert - Case No COMP/M.1878 - Regulation (EEC) No 4064/89 http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1878_en.pdf 
Merger Procedure - Hoechst / Rhône Poulenc - Case No IV//M. 1378 - Regulation EEC n° 4064/89 (55 pages) http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1378_en.pdf 
Merger Procedure - Bain / Hoechst-Date Behring - Case No IV/M.954 -Regulation (EEC) No 4064/89 http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m954_en.pdf 
Functional Foods Sweden - home page - "The Centre represents national coordination and acts as an initiator and catalyst for strategic activities aimed at enhancing development, and for the creation and implementation of functional food projects" http://www.functionalfoods.nu/dyndefaultframe.asp 
Sano-Synthelabo - home page - in English http://www.sanofi-synthelabo.fr/us/index.asp 
Intellectual Property Institute - home page - "to promote awareness and understanding of intellectual property law and its contribution to economic and social welfare" http://www.ip-institute.org.uk/ 
NERA - The Role of Supply-Side Substitution in the definition of the Relevant Market in Merger Control - A Report for DG Enterprise A/4,
European Commission - June, 2001 - (98 pages)
http://europa.eu.int/comm/enterprise/library/lib-competition/doc/supply-side_substitution.pdf  
Remed - Network for medicines and developpement - home page - "focusing its thinking and action on problems existing in the field of pharmaceuticals in the developing countries" http://www.remed.org/html/en_welcome.html 
NERA - Simon Bishop and Derek Ridyard - EC Vertical Restraints Guidelines: Effects-based or per se policy - (3 pages) http://www.nera.com/wwt/publications/4950.pdf 
Michal Cohen - Patent Protection of Biotechnological Inventions – Economic Perspectives and the EC Directive Analysis - August 2001 - (63 pages) http://www.frg.eur.nl/rile/emle/Theses/cohen.pdf 
Reversal of Fortune? An Assessment of the German Biotechnology Sector in Comparative Perspective - editor: Stephen H. Silvia - Economic Studies Program Series Volume 5 - (60 pages) http://www.aicgs.org/publications/PDF/biotech.pdf  
NERA - Derek Ridyard - Exclusionary Pricing and Price Discrimination Abuses Under Article 82: An Economic Analysis - (30 pages) http://www.nera.com/wwt/publications/4966.pdf 
Communication from the European Communities and their Member States to the TRIPS Council - The Relationship Between the Provisions of the TRIPS Agreement and Access to Medicines - Brussels, 13 June 2001 - (5 pages) http://europa.eu.int/comm/trade/pdf/med_trips.pdf 
The European Commission - DG Trade - Access to Medicines - Home page http://europa.eu.int/comm/trade/csc/med.htm 
Compulsory Licensing under TRIPs and Data Exclusivity - (24 pages) http://europa.eu.int/comm/trade/pdf/med_lic.pdf 
Attilio Stajano - Making Academia aware of Intellectual Property Rights (IPR) – comparing US and EU experiences - October 1999 - (22 pages) http://www.spbo.unibo.it/~stajano/ipr-eu-us.pdf  
Philippe Demenet - The high cost of living - Le Monde Diplomatique - February 2002 http://www.en.monde-diplomatique.fr/2002/02/04stavudine 
Sivaramjani Thambisetty - Human Genome Patents and Developing Countries - Study Paper 10 - Commission on Intellectual Property Rights -
- February 2002 - (70 pages)
http://www.iprcommission.org/documents%5Cthambisetty%20study.pdf 
Peter Drahos -Developing Countries and International Intellectual Property Standard-setting - Commission on Intellectual Property Rights
Study Paper 8 -February 2002 - (52 pages)
http://www.iprcommission.org/documents%5CDrahos%20study.pdf 
Michael Blakeney - Access to Genetic Resources, Gene-based Inventions and Agriculture - Commission on Intellectual Property Rights - Study Paper 3b - February 2002 - (39 pages) http://www.iprcommission.org/documents%5CBlakeney%20study.pdf 
Dwijen Rangnekar - Access to Genetic Resources, Gene-based Inventions and Agriculture - Commission on Intellectual Property Rights
Study Paper 3a - (73 pages)
http://www.iprcommission.org/documents%5CRangnekar%20study.pdf 
B. Zorina Khan - Intellectual Property and Economic Development: Lessons from American and European History - Commission on Intellectual Property Rights Study Paper 1a -February 2002 - (58 pages) http://www.iprcommission.org/documents%5CKhan%20study.pdf 
THE SOUTH AFRICAN DRUGS CASE - CIPR (British) Commission on Intellectual Property - June 2001 - (8 pages) http://www.iprcommission.org/documents%5CS%20Africa.pdf 
CIPR - Commission on Intellectual Property Rights - home page - "The Commission has been set up by the British government to look at how intellectual property rights can work better for poor people and developing countries" http://www.iprcommission.org/index.asp 
European Forum for Good Clinical Practice EFGCP http://www.efgcp.org/ 
NERA - Comment on the Interim Wanless Report - Securing Our Future Health: Taking a Long-Term View - January 2002 - (19 pages) http://www.nera.com/wwt/publications/4974.pdf 

 

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