In this follow-up to the best-selling Parallel Importing Strategies, 1998 Edition, John Barker, leading authority on parallel pharmaceutical distribution, provides expert insight into significant regulatory developments on parallel imports in the past 2�3 years, as well as future industry trends.
This new report summarises landmark developments and identifies further areas of possible opportunity for both the pharmaceutical industry and parallel distributors, providing indispensable information for readers on both sides of the trading divide.
The report answers key questions, including:
PUBLISHED: August 2000
REF: BS1069E
PAGES: 109
PRICE: £395/$830/¥119,000
CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ABBREVIATIONS
CHAPTER 1 AN INTRODUCTION TO PARALLEL TRADE IN
PHARMACEUTICALS
1.1 Why does parallel trade exist?
1.2 How does the trade work?
1.2.1 Regulatory issues for parallel trade
1.3 Interested parties
1.3.1 Background to parallel pharmaceutical trade
1.3.2 Players in the parallel pharmaceutical distribution
industry
1.4 Drivers of parallel pharmaceutical trade
1.4.1 Prescribers
1.4.2 Pharmacists
1.4.3 Supply chain
1.5 Market share
1.5.1 The prescription market
1.5.2 The parallel market
CHAPTER 2 EUROPEAN COMMISSION: PROGRESS TOWARDS
A SINGLE MARKET
2.1 European Commission's position on parallel trade
2.1.1 Overview
2.2 Background: free movement of goods
2.3 Single market in pharmaceuticals
2.3.1 Recent developments and implications
2.3.2 Bangemann III outcomes
2.4 Forcing EU pricing convergence: a practical scenario?
2.4.1 Principles
2.5 Enlargement of the EU: opportunities and threats for the
parallel pharmaceutical distribution industry
2.5.1 Background
2.5.2 Key issues
CHAPTER 3 REGULATORY ISSUES IN EUROPE
3.1 Overview of the European regulatory framework
3.2 European Medicines Evaluation Agency
3.3 Marketing authorisations
3.3.1 Centralised procedure
3.3.2 Decentralised procedure (mutual recognition)
3.3.3 National procedure
3.4 Good distribution practice
3.5 Pharmaceutical packaging
3.5.1 Abridged applications
3.5.2 Marketing authorisations and parallel distributors
3.6 Advertising
3.7 Pharmacovigilance
3.8 Pricing
3.9 Pharmaceutical Price Regulation Scheme
3.9.1 Modulation
3.10: An overview of pricing systems within the Common Market
CHAPTER 4 RECENT LEGAL CASES
4.1 Repackaging of pharmaceuticals (Paranova)
4.2 Supply restriction (Bayer AG)
4.3 Dual pricing policy (Glaxo Wellcome, Organon)
4.4 New versions of drugs (Rh�ne-Poulenc Rorer, AstraZeneca)
4.4.1 Zimovane
4.4.2 Losec
4.5 Exhaustion of trade names (Silhouette International et al)
4.6 Summary
CHAPTER 5 INTELLECTUAL PROPERTY and FREE TRADE
5.1 Principle of exhaustion of rights
5.1.1 Intellectual Property Rights: Introduction
5.2 Regional exhaustion of intellectual property rights: Europe
5.3 International exhaustion of Intellectual Property Rights
5.4 Opportunities and threats of international exhaustion
5.5 World Trade Organisation and World Intellectual Property
Organisation
5.6 Conclusions: next steps
CHAPTER 6 COMMERCIAL OPPORTUNITIES AND THREATS
6.1 Successful strategies in reducing the impact of parallel
distribution of pharmaceuticals
6.2 Unsuccessful strategies
6.2.1 Legal confrontational policies
6.3 Impediments to intra-EU trade
6.3.1 Product specifications
6.3.2 Price convergence
6.3.3 Supply limitations
6.4 Counter-strategies employed by - and for - the development of
the Parallel Products Distribution Industry
6.5 Impact of the Euro on the Parallel Products Distribution
Industry
6.5.1 Introduction
6.5.2 Possible effects arising from the introduction of the Euro
6.5.3 Conclusions
CHAPTER 7 FUTURE DEVELOPMENTS
7.1 The Parallel Product Distribution Industry: the next steps
7.2 Legal issues
7.2.1 Pharmaceutical repackaging
7.2.2 International exhaustion of Intellectual Property Rights
7.2.3 Supply availability
7.2.4 Discriminatory pricing
7.3 Position of the European Commission
7.4 European Union enlargement: opportunities and threats to the
Parallel Products Distribution Industry
7.5 E-commerce and parallel trade
7.6 Globalisation: probable trends
7.6.1 Trade Related Aspects of Intellectual Property Rights
clarification
7.6.2 Costs of pharmaceuticals
7.7 The Pharmaceutical Price Regulation Scheme and the UK
Government
7.8 Into the new millennium for the Parallel Products
Distribution Industry
APPENDIX I SCHEDULE OF PRINCIPAL ECJ DECISIONS
IMPACTING UPON THE DEVELOPMENT OF THE PARALLEL PHARMACEUTICAL
DISTRIBUTION INDUSTRY
APPENDIX II SCHEDULE OF PRINCIPAL COMMUNITY
DIRECTIVES IMPACTING UPON THE PHARMACEUTICAL PARALLEL
DISTRIBUTION INDUSTRY
APPENDIX III
APPENDIX IV RELEVANT ARTICLES OF THE TREATY OF
ROME
APPENDIX V SUGGESTED FURTHER READING
REFERENCES
LIST OF TABLES
Table 1.1 Global pharmaceutical sales rankings,
1998
Table 1.2 Estimated penetration of distributed
branded prescription pharmacueticals in the main user Member
States, 1999
Table 1.3 Growth patterns in PPDI in six Member
States
Table 1.4 Schedule showing the spread of
parallel distribution licence applications in Germany by source
country
Table 3.1 National controls on supply
Table 3.2 Prescribing, dispensing and
consumption
LIST OF FIGURES
Figure 1.1 Ranking of drug companies by R&D
expenditure
Figure 1.2 The number of parallel pharmaceutical
import licenses issued by the UK Medicines Control Agency, 1996-1999.
Figure 1.3 The number of parallel importing
licences approved in Germany, 1983-1998.
Figure 7.1 Sales of prescription products in
leading markets, 1999.
EXECUTIVE SUMMARY
The last few years have witnessed the maturing of the cross
border trade in prescription medicines between Member States of
the European Union (EU) and import/export trade into a mature,
professionally managed, pan-European distribution industry. In
the UK alone, those companies that qualified for membership in
The British Association of European Pharmaceutical Distributors (BAEPD;
formerly 'Association of Pharmaceutical Importers') account for
over �900 million at reimbursement prices of prescription
medicines into the national supply chain. The portfolio of
products offered includes generic medicines, UK-branded
preparations, as well as those procured from other EU Member
States through parallel trade.
The Pharmaceutical Parallel Distribution Industry (PPDI) is now a
major employer of skilled and semi-skilled labour with an
increasingly significant number of part-time employees within
facilities located in urban areas, some of which lie within
economically deprived regions.
Its continued growth is largely a testament to the continued confrontational strategies adopted by members of the research-based sector in their ongoing attempt to hinder or impede the free movement of goods, a pivotal objective of the community marketplace.
The creation of the Community has highlighted the conflict between competition on the one hand, and monopoly granted through the issuance of Intellectual Property Rights (IPRs) on the other. Nowhere, perhaps, has this conflict been more actively pursued through the courts (both national and European) than by the manufacturers of branded medicines. Despite having constantly and continually 'lost' almost every single action, the programme shows little sign of abatement by many of the multinational players: it was once suggested that the game being played out was as though there was a 'death wish' in some board rooms.
The last 2-3 years have seen an ever-increasing number of EU Member States adopting procedures that facilitate the parallel trade in pharmaceuticals. Those countries that were previously perceived as 'importers' now often enjoy a healthy parallel 'export' trade. Examples falling into such a category would include Germany, the Netherlands as well as the UK. Some countries that were classified solely as 'exporters', eg Italy, now have a limited number of products procured from other Member States.
Perhaps the two most important legal decisions over the past two years have been those of the European Court of Justice (ECJ) in R versus the Medicines Control Agency ex parte Rh�ne-Poulenc Rorer, and the judgement of the English High Court (Chancery Division) on Glaxo Group et al versus Dowelhurst et al, which was handed down as recently as 28 February 2000 by Mr Justice Laddie. The former case is examined in Chapter 4, Section 4, and the latter in Chapter 4, Section 1.
There remain a number of referred cases presented before the Court of First Instance (CFI) and before the ECJ. Therefore, the history of PPDI is still being written. Of the issues that have yet to be finally decided, probably the most potentially significant is that relating to the alleged restriction of product supply, ie the Commission versus Bayer case that was presented before the CFI. It is probable that, whenever the decision comes out of the Court, it will be appealed to the ECJ, which means that a final determination is unlikely to be found before 2002.
In the months ahead, the debate within a number of EU Member States will be increasingly focused upon the ever-growing cost of the provision of healthcare to an ageing population; within this debate, considerable vocal concerns will be perceived on the issue of the spiralling cost of medicines. There is an increasing number of improved formulations coming onto the market, but at significantly higher prices. The portfolio of products offered through the PPDI has never been more appealing in today's competitive environment.
There will also be an increasing awareness of the need to
debate the issue of rights within the context of international
exhaustion which clearly offers considerable benefits to the
consumer, the taxpayer and, in an increasing number of instances,
the patient. Heightened vocal concern at the potential abuse of
market power through IPR is inevitable. There has already been a
foretaste of the strength of feeling, as witnessed at the World
Trade meeting in Seattle and, more recently, at the Washington
gathering of the International Monetary Fund and World Bank.
To dismiss such protests as the ravings of minority groups would
be a dangerous underestimate of the depth of real concern that is
now being manifested through the ordinary person in the street.
The information technology revolution, as expressed in knowledge
creation and awareness, is having an unexpected but inevitable
impact upon areas which hitherto have been largely immune from
general public scrutiny and understanding.
On a more pedantic scale, the possibilities for the PPDI following the Laddie J decision on the repackaging of medicinal preparations will, subject to clarification from the ECJ on aspects of Community law, open a completely new spectrum of commercial opportunities which should generate additional competitive pressures within the controlled market of branded medicines.
Chapter 1 of the report reviews in outline the reasons for the existence of parallel trade in pharmaceuticals within the European Economic Community (EEC). It includes a brief overview of how the trade works in practice, including a discussion of the regulatory issues, the principal players and drivers of PPDI.
The attitude of the European Commission (EC) is presented in Chapter 2. This chapter examines the position that has been developed by the Commission over the years, as it continues to strive towards its stated goal of achieving a single market in pharmaceuticals. A review is provided to the background and achievements of the Bangemann Round Tables from 1996 through 1998: this is followed by a commentary upon the possibilities of price convergence within Member States as well as an examination of some of the possible consequences of the proposed enlargement of the Community.
Chapter 3 considers the regulatory regimen that governs PPDI within Europe, particularly the impact of the Centralised Authorisation procedure controlled by the European Medicines Evaluation Agency (EMEA) in London. This logically takes the author into a consideration of good distribution practice, as well as a discussion on some of the commercial implications of the repackaging of pharmaceutical preparations prior to placing such items into a domestic supply chain. Finally, and because the issue is before the English Courts, a cursory review of the unique pricing scheme that is applicable to the market in the UK is undertaken.
The continued development of jurisprudence governing the
development of PPDI is considered in some depth in Chapter 4,
through a review of the more recent decisions which have been
handed down both from selected national courts as well as from
the ECJ. The principal areas of legal opinion cover product
supply (the Bayer case), product pricing (Glaxo Wellcome dual
pricing in Spain), regulatory issues (Rh�ne-Poulenc Rorer and
Zimovane), and the repackaging of pharmaceuticals in order to
obtain full market access (Glaxo Group et al).
Chapter 5 hosts a debate on the conflicts that have arisen - and
will probably continue to do so in the future, between
competition and free trade versus monopolies created by IPRs. The
issues covered include both regional and international exhaustion
of IPRs, with the attendant benefits that would flow from the
adoption of such a regimen.
Commercial opportunities and threats to PPDI are covered in Chapter 6. Counter-strategies are examined, together with the impact of the Euro upon the industry.
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