對於醫藥品並行貿易的對策

Parallel trade is the process by which goods protected by an intellectual property right, such as a patent or trademark, placed in circulation in one market, are imported into a second market without the authorisation of the IP right' s holder. It provides a local supplier with a unique problem - competition from his own brand.

Parallel trade with prescription medicines occurs between the 30 countries that make up the European Economic Area (EEA) as a consequence of the principles of free movement of goods and intra-EEA exhaustion of IP rights. Ongoing for more than 40 years, its level may have peaked overall but it still accounts for the following retail market shares by value: 16% in Denmark, 14% in both the UK and Sweden, 11% in the Netherlands, 8% in Norway, and 6% in Germany. At pharmacy buying prices, parallel trade in the top four destination markets of the UK, Germany, Netherlands and Sweden totals more than € 2700 million.

Incoming parallel trade at much lower levels is also found in many other EEA countries. Spain, Greece, France, Italy and Portugal are the main source nations. Increasingly, several countries act simultaneously as both source and destination markets (with different products). Concentration on blockbusters is lessening, largely as a result of traders looking to second-tier products as they encounter supply difficulties with the major brands. To market a parallel-traded product, the importer requires either an abbreviated marketing authorisation for the product from the national regulatory authority in the country of destination, or, in the case of centrally-approved medicines, a parallel distribution notice from the European Medicines Agency (EMEA).

In the case of products sourced from any of the 10 CEE member states that joined the EU in 2004 or the two that joined in 2007, the importer is also required to give one month' s notice to the patent holder prior to filing for marketing approval to enable a check for compliance with the specific mechanism to be made. This mechanism is designed to block east-west parallel trade with individual products while there are disparities in patent/SPC status.

Before a parallel-traded product can be marketed, either re-labelling in the local language or replacing the outer carton is required. In order for an importer to do this without infringing trademark law, all five criteria set out by the European Court of Justice (ECJ) in the Bristol-Myers Squibb cases have to be met:

• Any refixing or replacing of the original trademark must be necessary in order for the imported product to be marketed.
• The original condition of the product inside the packaging is not affected.
• The new packaging states who manufactured the product and who repackaged it.
• The presentation of the repackaged product does not damage the reputation of the trademark and its owner.
• The trademark owner is given adequate prior notice before the repackaged product is put on sale and, on demand, is supplied with a specimen of the repackaged product.

The only justification for parallel trade is to bring savings to payers, but evidence of the level of savings and the main beneficiaries is mixed. Because of the number of intermediaries involved in parallel trade and their costs, the actual net saving compared with the inter-state product price differentials is small.

Actual evidence linking parallel trade with ease of access of counterfeit medicines has only recently surfaced.

Table of Contents

• 1.1 Basics
• 1.2 How it works
• 1.3 How it began
• 1.4 How it developed
• 1.5 The scale of the issue
• 1.6 Arguments for and against

• 2.1 National regulatory approval
  • 2.1.1 Criteria employed
  • 2.1.2 Application procedure
  • 2.1.3 Assessment
  • 2.1.4 Conditions
• 2.2 Parallel distribution of centrally-approved medicines
• 2.3 Specific mechanism
• 2.4 Repackaging/re-labelling
  • 2.4.1 Trademarks
    • 2.4.1.1 The BMS case
    • 2.4.1.2 The Boehringer case
  • 2.4.2 Copyright
  • 2.4.3 Quality concerns

• 3.1 Impact on investment in R&D
• 3.2 Impact on launch decisions
• 3.3 Shortages created by parallel exporting
• 3.4 Savings from parallel trade
• 3.5 Counterfeits and parallel trade
  • 3.5.1 Industry view
  • 3.5.2 Other contributors
  • 3.5.3 Traders' response
    • 3.5.3.1 UK
    • 3.5.3.2 Germany
    • 3.5.3.3 Denmark
  • 3.5.4 Evidence
• 3.6 Diversion of compassionate relief supplies

• 4.1 Major countries of destination
  • 4.1.1 Denmark
  • 4.1.2 Finland
  • 4.1.3 Germany
  • 4.1.4 Netherlands
  • 4.1.5 Norway
  • 4.1.6 Sweden
  • 4.1.7 United Kingdom
    • 4.1.7.1 PL(PI) scheme
    • 4.1.7.2 Savings
    • 4.1.7.3 PPRS
• 4.2 Major source countries
  • 4.2.1 Greece
  • 4.2.2 Spain
  • 4.2.3 Other countries
    • 4.2.3.1 Austria
    • 4.2.3.2 Belgium
    • 4.2.3.3 France
    • 4.2.3.4 Portugal
    • 4.2.3.5 Poland

• 5.1 Main manufacturer counter-strategies to PT
• 5.2 Risks
  • 5.2.1 Commercial risks
  • 5.2.2 Legal risks
    • 5.2.2.1 Treaty of Rome
    • 5.2.2.2 Directive 2004/27/EC
  • 5.2.3 Summary of legal processes

• 6.1 Price corridors
• 6.2 Euro-based pricing
• 6.3 Price reductions
• 6.4 Brand equalisation deals
• 6.5 Dual pricing
  • 6.5.1 GW' s scheme
  • 6.5.2 Pfizer' s scheme
    • 6.5.2.1 Article 100
    • 6.5.2.2 Pfizer makes changes
    • 6.5.2.3 Royal decree
• 6.6 Free pricing with rebates
  • 6.6.1 Pan-European opportunity
  • 6.6.2 National opportunities

• 7.1 Export prohibition
• 7.2 Stock allocation
  • 7.2.1 Article 81: The Adalat case
  • 7.2.2 Article 82
    • 7.2.2.1 Relevant product market
    • 7.2.2.2 The Syfait case
    • 7.2.2.3 France' s Competition Council
  • 7.2.3 Where are we now?
• 7.3 Direct distribution
  • 7.3.1 Involvement of wholesalers in PT
  • 7.3.2 Examples of direct distribution

• 8.1 Don' t rush to ‘do something'
• 8.2 Don' t forget to use your full rights
• 8.3 Don' t let lawyers drive the agenda (but do take early legal advice)
• 8.4 Supply management schemes can work (and stay within the law)
• 8.5 Responding to incoming PT with price cuts is generally not advisable
• 8.6 Dual pricing opportunities exist (but mainly in Spain)
• 8.7 Emphasise to payers that savings from PT are very limited
• 8.8 Emphasise that savings to patients are almost non existent

• 9.1 United States
  • 9.1.1 Personal importation
  • 9.1.2 Legislative attempts
    • 9.1.2.1 Bipartisan bill
    • 9.1.2.2 Impact limited?
• 9.2 Switzerland
• 9.3 Israel
• 9.4 Philippines

• 10.1 No single European price
• 10.2 Waning EU support
  • 10.2.1 European Commission
  • 10.2.2 ECJ
  • 10.2.3 European Parliament
  • 10.2.4 EMEA
• 10.3 National drivers and restraints remain important
• 10.4 EU enlargement less of a threat
• 10.5 No product now immune
• 10.6 No country now immune
• 10.7 Manufacturers regaining control of distribution
• 10.8 Changes among parallel traders
  • 10.8.1 Diversification
  • 10.8.2 Exits
• 10.9 Prospects for US

REFERENCES

APPENDIX 1: ECJ JUDGMENTS ON PHARMACEUTICAL PARALLEL TRADE

APPENDIX 2: EUROPEAN ASSOCIATION OF EURO-PHARMACEUTICAL COMPANIES (EAEPC)

APPENDIX 3: EAEPC GOOD PARALLEL DISTRIBUTION PRACTICE GUIDELINES FOR MEDICINAL PRODUCTS

APPENDIX 4: PL(PI) LICENCE HOLDERS IN UK

• Table 1.1 EU member states
• Table 1.2 Commercial versus personal importation
• Table 1.3 Principal outcome of pharmaceutical parallel trade cases at ECJ
• Table 1.4 Evolution of parallel trade (% of pharmacy market sales)
• Table 1.5 Value of PT in medicines (€ million) at pharmacy purchase prices, 2002
• Table 2.1 Parallel distribution notifications to EMEA, 2004-2006
• Table 2.2 Introductory dates for patents and SPCs in CEE countries
• Table 3.1 Direct savings from parallel trade (€ million)
• Table 4.1 Evolution of PT penetration in Germany
• Table 4.2 Numbers of applications and regulatory approvals for PIs in the Netherlands
• Table 4.3 Evolution of PT penetration in the Netherlands
• Table 4.4 Evolution of PT penetration in Norway
• Table 4.5 Evolution of national PT regulatory approvals in Sweden
• Table 4.6 Evolution of PT penetration in Sweden
• Table 4.7 Evolution of PT penetration in the UK
• Table 4.8 Number of PL(PI)s issued in UK
• Table 4.9 Top-10 UK importers by numbers of PL(PI)s issued January 2005-June 2007
• Table 4.10 Country of origin of PL(PI)s approved to November 2002
• Table 4.11 Impact of price modulation with 2005 PPRS on PI penetration of selected brands
• Table 4.12 Evolution of parallel exports from Greece
• Table 4.13 Decline in the Spanish wholesaler margin
• Table 5.1 Main PT counter-strategies
• Table 5.2 National competition authorities in the EU
• Table 6.1 Hitting PT, or the bottom line?
• Table 6.2 Glaxo Countdown to an EU stalemate
• Table 6.3 Specimen annex 1/annex 2 price differences offered by Pfizer Spain, June 2005
• Table 6.4 ‘Dual pricing' schemes in Spain
• Table 7.1 Syfait - Countdown to a non-decision
• Table 7.2 Turnover of French ‘export-only' wholesalers (€ million), 2002
• Table 7.3 Export sales of leading French wholesalers, € million
• Table 8.1 Time delays before parallel trade judgments have been decided by the ECJ
• Table 9.1 Top 10 drug classes sold to Canada-US cross border pharmacies, 2004