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TURKISH COMPETITION AUTHORITY
How Do We Approach
Pay-for-Delay
Agreements?
OECD, Paris
Feb 2019
Cigdem Gizem OKKAOGLU
Merve BIROGLU
2
1. General View of the Pharmaceuticals Sector
2. Frequent Case Topics
3. Approach to Pay-for- Delay Agreements
4. Relevant Cases
Outline
3
- Prices are regulated by the government based on a
reference system
- France, Spain, Italy, Portugal, Greece
- Minimum sale price given to warehouses
- Euro is converted to Turkish Liras, by taking the 70%
of previous year’s average Euro/TL exchange rate
- Government is the biggest buyer of pharmaceuticals
and receives large discounts
- Therefore prices are lower than in most EU countries
- Market is ripe for parallel trade
- Maximum profit rates of pharmacy warehouses and
pharmacy shops are pre-determined
1. General View of the Pharmaceuticals Sector
4
- Act No 4054 Article 4 corresponding to TFEU Article 101(1)
- Discrimination based on price, terms of payment
- Warehouses file a complaint about producers
- Act No 4054 Article 5 corresponding to TFEU Article 101(3)
- Block/Individual Exemptions
- Horizontal or vertical agreements
- Act No 4054 Article 6 corresponding to TFEU Article 102
- Refusal to Supply
- Exclusionary Conduct
2. Frequent Case Topics
5
3. Approach to Pay-for-Delay Agreements
- More than 300 types of agreements between originators
and generic manufacturers (license, supply, distribution,
joint marketing, production etc.)
- The objective of pay-for-delay agreement can be achieved
by other types of agreements such that:
- Originator might give a licence to the generics
manufacturer in one market so that it does not enter
another market
- Marketing/distribution agreement prevents generics
manufacturer from entering the market
- It is important to evaluate the contract terms carefully to
understand the intention kept in the background
6
GlaxoSmithKline(GSK)/Bilim Ilac Decision (2017)
- Individual exemption for the marketing agreement bw parties
- Bilim Ilac supports marketing activities for GSK’s Seretide
- Bilim Ilac is a generics manufacturer of Seretide (Ventofor
Kombi in the same market based on ATC-3 classification)
- Is pay-for-delay agreement hidden behind the cooperation?
- Bilim Ilac was questioned and the agreement was granted
individual exemption
Allergan/Abdi Ibrahim Decision (2010)
- Individual exemption for the distribution agreement bw parties
- 5 years long non-competition clause prevents Abdi Ibrahim from
entering the market with generics
- Abdi Ibrahim is the strongest potential competitor of Allergan
- Agreement is granted individual exemption with the condition
that Allergan removes the non-competition terms
4. Relevant Cases
7
Thank you!
Contact: cokkaoglu@rekabet.gov.tr
Q&A
8

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How Do We Approach Pay-for-Delay Agreements?

  • 1. TURKISH COMPETITION AUTHORITY How Do We Approach Pay-for-Delay Agreements? OECD, Paris Feb 2019 Cigdem Gizem OKKAOGLU Merve BIROGLU
  • 2. 2 1. General View of the Pharmaceuticals Sector 2. Frequent Case Topics 3. Approach to Pay-for- Delay Agreements 4. Relevant Cases Outline
  • 3. 3 - Prices are regulated by the government based on a reference system - France, Spain, Italy, Portugal, Greece - Minimum sale price given to warehouses - Euro is converted to Turkish Liras, by taking the 70% of previous year’s average Euro/TL exchange rate - Government is the biggest buyer of pharmaceuticals and receives large discounts - Therefore prices are lower than in most EU countries - Market is ripe for parallel trade - Maximum profit rates of pharmacy warehouses and pharmacy shops are pre-determined 1. General View of the Pharmaceuticals Sector
  • 4. 4 - Act No 4054 Article 4 corresponding to TFEU Article 101(1) - Discrimination based on price, terms of payment - Warehouses file a complaint about producers - Act No 4054 Article 5 corresponding to TFEU Article 101(3) - Block/Individual Exemptions - Horizontal or vertical agreements - Act No 4054 Article 6 corresponding to TFEU Article 102 - Refusal to Supply - Exclusionary Conduct 2. Frequent Case Topics
  • 5. 5 3. Approach to Pay-for-Delay Agreements - More than 300 types of agreements between originators and generic manufacturers (license, supply, distribution, joint marketing, production etc.) - The objective of pay-for-delay agreement can be achieved by other types of agreements such that: - Originator might give a licence to the generics manufacturer in one market so that it does not enter another market - Marketing/distribution agreement prevents generics manufacturer from entering the market - It is important to evaluate the contract terms carefully to understand the intention kept in the background
  • 6. 6 GlaxoSmithKline(GSK)/Bilim Ilac Decision (2017) - Individual exemption for the marketing agreement bw parties - Bilim Ilac supports marketing activities for GSK’s Seretide - Bilim Ilac is a generics manufacturer of Seretide (Ventofor Kombi in the same market based on ATC-3 classification) - Is pay-for-delay agreement hidden behind the cooperation? - Bilim Ilac was questioned and the agreement was granted individual exemption Allergan/Abdi Ibrahim Decision (2010) - Individual exemption for the distribution agreement bw parties - 5 years long non-competition clause prevents Abdi Ibrahim from entering the market with generics - Abdi Ibrahim is the strongest potential competitor of Allergan - Agreement is granted individual exemption with the condition that Allergan removes the non-competition terms 4. Relevant Cases