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Publication Date: September 2008
Very little in the pricing environment in Europe is predictable to pharmaceutical companies and only rarely is much notice given of change. But before the end of 2009, if the European Court of Justice accepts the arguments put to it forcefully by the European Commission and by DocMorris, then revolutionary reform among industry’s main customer group, the community pharmacist, in several of the main countries, including 4 of the EU-5, will get the green light. The main issue to be resolved, whether national regulations on pharmacy ownership and establishment of new premises infringe EU law, is of wider importance than for the pharmacy profession alone. It amounts to a battle over control of healthcare provision between Brussels and the member states, with the outcome also of great significance to patients, wholesalers, manufacturers and payers.
Pharmacy Liberalisation in Europe: Prospects and Implications provides fully researched, up-to-date information and interpretation on what deregulation could mean to all participants in the medicines’ market. Whether your interest is in marketing prescription brands, generics or OTCs, in their distribution, or in paying the bill for them, this report is for you. To be forewarned of what might happen will allow adequate preparation for it.
The report addresses:
- Background and current status of infringement actions brought by the European Commission against seven EU member states, plus the key ECJ case involving the controversial DocMorris pharmacy in the Germany city of Saarbrücken.
- The arguments for and against reform.
- What might happen, who would be the winners and the losers.
- Details of the current ownership structure and ownership rules for pharmacies in countries all across Europe from Iceland to Cyprus.
- Interdependency of pharmacy and wholesaling, and how this could evolve.
- What lessons can be found from markets that have already deregulated.
- How vertical integration impacts the reimbursement of multisource products and the response by payers to this.
- The latest on plans to break up Apoteket’s pharmacy monopoly in Sweden.
- Liberalisation of OTC sales channels.
About the Author
With well over 50 major titles to his name, Donald Macarthur is one of the world’s most experienced and widely read commercial biopharmaceutical writers. Known for his clear, succinct and eminently readable style, where the emphasis is on imparting understanding. Every report deals with the subject comprehensively in a neutral, fact-based manner. Each is based on up-to-the-minute research by the author himself - largely primary research in the field - among government officials,industry and other experts on the topic concerned. Rather than a rehash of the published literature readers will find detail, insight and forecasts not found elsewhere.
For two years up to June 2007, Don Macarthur was senior consultant with the strategic international pharmaceutical pricing, reimbursement and market access consultancy PriceSpective. From 2001-2005, Mr Macarthur was Secretary General of the European Association of Euro-Pharmaceutical Companies, the grouping of national associations and individual firms involved in parallel trading of medicines with membership from 16 EEA countries.
His current role as independent consultant and analytical writer also occupied the bulk of the 16 years preceding 2001, with a focus on drug cost containment policy worldwide, pricing and reimbursement, hospital access, European integration and enlargement, wholesale and retail distribution, mail order, homecare, orphan drugs, generics, parallel trade, Rx-to-OTC switching, and several aspects of the Japanese market and industry.
He has written over 50 major reports. Published by Scrip, IMS Health, Financial Times/Informa, Taylor Nelson Sofres Healthcare, Decision Resources, Droit & Pharmacie, PPR Communications and himself, several have become industry standards. He also founded, edited and published for four years the world’s first periodical on drug pricing and reimbursement, Pharma Pricing Review.
Consultancy clients have included the European Federation of Pharmaceutical Industries and Associations - he was the very first consultant ever used by EFPIA - Pharmaceutical Research and Manufacturers of America (PhRMA), the European grouping of national full-line pharmaceutical wholesaling associations (GIRP), the UK’s Office of Fair Trading, other government agencies, and many major multinational biopharmaceutical manufacturers, legal and financial firms.
Numerous presentations have been given at international conferences, and he has testified both at a US Senate Committee hearing and at the HHS Secretary’s task force hearing on prescription drug importation. His articles have appeared in many English language pharmaceutical business journals, with some translated into Japanese, German and Turkish.
Qualifying as a pharmacist from the University of London, Mr Macarthur’s early career involved community and hospital pharmacy practice, 16 years in development, regulatory affairs and medical department functions in the pharmaceutical industry in the UK (Fisons, 1969-72; Parke-Davis, 1972-75; Roche, 1976-78; Serono, 1978-82; Lundbeck 1982-84), one year in Japan, and four years with PJB Publications (publishers of Scrip).
Table of Contents
1.1 Community Pharmacy
1.2 Pharmacy Regulations
1.3 Intervention by the European Commission
1.4 Limitations on Commission Action
2. The Arguments
2.1 National Developments
2.2 Other Contributions to the Debate
2.2.1 ÖBIG Report for PGEU
2.2.2 ECORYS Report for European Commission
2.3 ECJ Oral Hearing in Italian and DocMorris Cases
2.4 Other Commission Interventions Concerning Pharmacy
3. Deregulation to Date
3.1 National Situation
3.2 Liberalisation of OTC Sales Channels
4. What Could Happen
4.1 More Pharmacies?
4.2 Are More Pharmacies Needed?
4.3 Greater Price Competition?
4.4 Pharmacy Acquisition by Wholesalers?
4.4.1 Profiles of Leading Wholesalers with Pharmacy Chains
220.127.116.11 Alliance Boots
4.4.2 Wholesalers’ Future Vision
4.4.3 Other Wholesalers with Pharmacy Chains
4.4.4 Other Forms of Wholesaler Involvement in Pharmacies
4.4.5 Pharmacist Ownership of Wholesalers
4.5 Pharmacy Acquisition by Other Types of Companies?
4.6 Distribution Changes in Sweden?
5.1 For Patients
5.2 For Pharmacy
5.3 For Other Professions
5.4 For Wholesalers
5.5 For Manufacturers
5.5.1 Impact on Rebate Agreements in Germany
5.5.2 Higher Distribution Costs in Sweden
5.5.3 Expansion of Homecare
5.6 For Governments/Third Party Payers
5.6.1 Reimbursement Problems with Multisource Products
5.6.2 Clawback Ineffective
List of Tables
1.1 Pharmacy and pharmacist demography in Europe
1.2 Share of medicine sales from wholesalers by customer group
1.3 Is it possible for a non-pharmacist to own a pharmacy?
1.4 Pharmacy regulation indices
1.5 Timetable of EU proceedings against pharmacy regulations
3.1 Pharmacies in Iceland
3.2 Leading pharmacy chains in Ireland
3.3 Leading pharmacy chains in Lithuania
3.4 Leading pharmacy chains in the Netherlands
3.5 Ownership structure of community pharmacies in Norway
3.6 Evolution of pharmacy numbers and share of chains in England
3.7 Evolution of supermarket pharmacies in UK
3.8 Evolution of large pharmacy chains in UK
4.1 Evolution of pharmacy numbers across Europe, 1995-2006
4.2 Other access points for medicines in Europe
4.3 Ranking of Europe’s ‘big 3’ wholesalers by country
4.4 Pharmacy ownership by leading wholesalers
4.5 Other wholesaler-owned pharmacy chains
4.6 Share of community pharmacies in virtual chains
1. Pharmacy Ownership and Establishment Criteria, 2008
2. European and National Pharmacy Associations
Glossary of Acronyms and Abbreviations