Poland, the largest market in central and eastern Europe, has weathered the global economic downturn better than many other countries across the continent. Its USD 6+ billion pharmaceutical sector (at ex-factory prices) in particular has been remarkably resilient, with value growth in each of the past three years exceeding 9%, the second highest increase in the EU. Traditionally a market dominated by generics, imported originator brands now account for 72% of sales Yet pricing and reimbursement processes are far from transparent, and if OTCs are included, patients are asked to pay 68% of the medicines’ bill out-of-pocket, a very high share for a country with a comprehensive social health insurance system.

Poland is full of surprises. Be better prepared and informed to tackle this dynamic emerging market. Pharmaceutical Pricing, Reimbursement & Distribution in Poland, 2010 and Beyond will provide you with clear, comprehensive, fully-researched and up-to-date information, including the following:

• How introductory prices are set.

• The complex forms of reimbursement explained with many illustrative examples.

• Alternatives to appearing on the positive list.

• How manufacturer discounts lessen the co-payment burden and drive market share.

• Therapeutic programmes for high-cost speciality drugs.

• Which products have maximum acquisition prices set for hospitals.

• First 12 months’ experience with AstraZeneca’s direct-to-pharmacy distribution model, the only form of exclusive DTP in Europe outside the UK.

• Two-way flow in one of Europe’s newest and fastest-growing parallel trade scenes.

• Reforms to P&R the government is now proposing and what these might mean for the pharmaceutical industry.

Executive Summary

1. Market Introduction

1.1 Healthcare System

1.2 Health Insurance

1.2.1 Public System

1.2.2 Private System

1.3 Pharmaceutical Market

1.4 Pharmaceutical Industry

1.5 Regulation

2. Introductory Pricing

2.1 Principles

2.2 Process

2.2.1 Medicines Management Team

2.2.2 Agency for Medical Technology Evaluations

2.2.3 External Reference Pricing

2.2.4 Internal Reference Pricing

2.3 Outcome

2.4 Price Revision

3.Key Role of Reimbursement

3.1. Classification

3.1.1 General Reimbursement

3.1.2 Chronic Disease Treatments

3.2 Reference Pricing

3.3 Illustrative Examples

3.4 Market Breakdown

3.5 Discounts to Patients

3.6 Revisions to Reimbursement List

3.6.1 Addition of New Products

3.6.2 December 2009 Listing

3.7 Controversies

4. Generics

4.1 Patents and Regulatory Issues

4.2 Generic Pricing

4.3 Generic Substitution

4.4 Generics ‘Wish List’

5. Hospital Market

5.1 Financing

5.2 Drug Selection

5.3 Procurement

5.4 Maximum Prices

5.5 Therapeutic Programmes

5.6 Non-standard Pharmacotherapy

5.7 Off-label Use

5.8 Patient Co-payment

5.9 Distribution

5.10 Antitrust Issues

6. Wholesaling

6.1 Leading Wholesalers

6.2 Wholesale Mark-up

7. Community Pharmacy

7.1 Pharmacy Growth

7.2 Multiples and Pharmacy Ownership

7.3 Pharmacy Mark-up

7.3.1 Reimbursed Products

7.3.2 Non-reimbursed Products

7.4 Rx-to-OTC Switching

8. Online Pharmacies

8.1 Regulatory Requirements

8.2 Leading Companies

9. Parallel Trade