This presentation by the Turkish Competition Authority was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by Duncan Matthews was made during the Workshop on Recent Challenges in Competition and IP in Pharmaceutical Markets on 26 February 2019. More material on the workshop can be found at www.oecd.org/daf/competition/workshop-on-recent-challenges-in-competition-and-ip-in-pharmaceutical-markets.htm
This presentation by Italy was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by Paul Lugard (BIAC) was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by the French Competition Authority was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by the Competition Bureau of Canada was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by Margherita COLANGELO, Associate Professor of Comparative Law, University of Roma Tre, was made during the discussion “Excessive Pricing in Pharmaceuticals” held at the 130th meeting of the OECD Competition Committee on 28 November 2018. More papers and presentations on the topic can be found out at oe.cd/exph.
This presentation by Farasat Bokhari was made at the 2014 Global Forum on Competition (27-28 February) at the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Duncan Matthews was made during the Workshop on Recent Challenges in Competition and IP in Pharmaceutical Markets on 26 February 2019. More material on the workshop can be found at www.oecd.org/daf/competition/workshop-on-recent-challenges-in-competition-and-ip-in-pharmaceutical-markets.htm
This presentation by Italy was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by Paul Lugard (BIAC) was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by the French Competition Authority was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by the Competition Bureau of Canada was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
This presentation by Margherita COLANGELO, Associate Professor of Comparative Law, University of Roma Tre, was made during the discussion “Excessive Pricing in Pharmaceuticals” held at the 130th meeting of the OECD Competition Committee on 28 November 2018. More papers and presentations on the topic can be found out at oe.cd/exph.
This presentation by Farasat Bokhari was made at the 2014 Global Forum on Competition (27-28 February) at the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Panos Kanavos was made at the 2014 Global Forum on Competition (27-28 February) at the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Sabine Vogler was made at the 2014 Global Forum on Competition (27-28 February) during the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Adrian Majumdar was made at the 2014 Global Forum on Competition (27-28 February) at the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Pradeep Mehta was made at the 2014 Global Forum on Competition (27-28 February) during the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Aidan Hollis was made at the 2014 Global Forum on Competition (27-28 February) during the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union.
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
Kiriasis Savvas, EIPG Greek Delegate
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
Pharma Maket Access - Southeast Europe & TurkeyZdravko Mauko
Key figures about pharmaceutical market access in southeast Europe and Turkey. Summary about market authorisations, pricing and reimbursement for Croatia, Serbia, Bosnia and Herzegovina, Macedonia, Kosovo, Albania, Bulgaria, Romania and Turkey
This presentation by Panos Kanavos was made at the 2014 Global Forum on Competition (27-28 February) at the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Sabine Vogler was made at the 2014 Global Forum on Competition (27-28 February) during the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Adrian Majumdar was made at the 2014 Global Forum on Competition (27-28 February) at the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Pradeep Mehta was made at the 2014 Global Forum on Competition (27-28 February) during the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This presentation by Aidan Hollis was made at the 2014 Global Forum on Competition (27-28 February) during the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union.
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
Kiriasis Savvas, EIPG Greek Delegate
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
Pharma Maket Access - Southeast Europe & TurkeyZdravko Mauko
Key figures about pharmaceutical market access in southeast Europe and Turkey. Summary about market authorisations, pricing and reimbursement for Croatia, Serbia, Bosnia and Herzegovina, Macedonia, Kosovo, Albania, Bulgaria, Romania and Turkey
Intellectual Property Rights with Special Reference to HealthSHUBHAM SINGH
A presentation on "Intellectual Property Rights with Special Reference to Health" by Jasvir Kaur after having a research paper on 'Intellectual Property Rights with Special Reference to Health' from Sardar Patel University of Police, Security & Criminal Justice, Jodhpur.
Achieving efficient pricing of pharmaceuticals between and within countries is a complex conceptually and critical a policy challenge. The optimal price that maximises social welfare must achieve two objectives: static efficiency, i.e. optimal use of existing products, and dynamic efficiency, i.e. optimal investment in R&D. This presentation reviews recent thinking on the core challenges.
This presentation gives an overview over the EFPIA transparency / disclosure code that requires pharmaceutical companies to disclose payments to doctors and healthcare institutions as of 2015. It supports a critical view on the initiative compared to similar sunshine requirements in other countries.
FG2A France (Fédération des Garanties et Assurances Affinitaires): Response of the consultation paper CP-16-2016 on Technical Advice on possible delegated acts concerning the Insurance Distribution Directive.
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
This presentation comprises highlights from the publication OECD Competition Trends 2024 published in Paris on 6 March 2024 during the OECD Competition Open Day. The full publication can be accessed at oe.cd/comp-trends.
This presentation by Cristina Camacho, Head of Cabinet and Head of International Relations, Portuguese Competition Authority, was made during the discussion “Use of Economic Evidence in Cartel Cases” held at the 22nd meeting of the OECD Global Forum on Competition on 8 December 2023. More papers and presentations on the topic can be found out at oe.cd/egci.
This presentation was uploaded with the author’s consent.
This presentation by William E. Kovacic, Global Competition Professor of Law and Policy and Director, Competition Law Center, The George Washington University, was made during the discussion “Ex-post Assessment of Merger Remedies” held at the 22nd meeting of the OECD Global Forum on Competition on 8 December 2023. More papers and presentations on the topic can be found out at oe.cd/eamr.
This presentation was uploaded with the author’s consent.
This presentation by John E. Kwoka, Neal F. Finnegan Distinguished Professor of Economics, Northeastern University, was made during the discussion “Ex-post Assessment of Merger Remedies” held at the 22nd meeting of the OECD Global Forum on Competition on 8 December 2023. More papers and presentations on the topic can be found out at oe.cd/eamr.
This presentation was uploaded with the author’s consent.
This presentation by Amelia Fletcher CBE, Professor of Competition Policy, University of East Anglia, was made during the discussion “Ex-post Assessment of Merger Remedies” held at the 22nd meeting of the OECD Global Forum on Competition on 8 December 2023. More papers and presentations on the topic can be found out at oe.cd/eamr.
This presentation was uploaded with the author’s consent.
This presentation by the OECD Secretariat was made during the discussion “Ex-post Assessment of Merger Remedies” held at the 22nd meeting of the OECD Global Forum on Competition on 8 December 2023. More papers and presentations on the topic can be found out at oe.cd/eamr.
This presentation was uploaded with the author’s consent.
This presentation by John Davies, Member, UK Competition Appeal Tribunal, was made during the discussion “Use of Economic Evidence in Cartel Cases” held at the 22nd meeting of the OECD Global Forum on Competition on 8 December 2023. More papers and presentations on the topic can be found out at oe.cd/egci.
This presentation was uploaded with the author’s consent.
This presentation by Simon Roberts, Professor, Centre for Competition, Regulation and Economic Development, University of Johannesburg, was made during the discussion “Use of Economic Evidence in Cartel Cases” held at the 22nd meeting of the OECD Global Forum on Competition on 8 December 2023. More papers and presentations on the topic can be found out at oe.cd/egci.
This presentation was uploaded with the author’s consent.
This presentation by Serbia was made during the discussion “Alternatives to Leniency Programmes” held at the 22nd meeting of the OECD Global Forum on Competition on 7 December 2023. More papers and presentations on the topic can be found out at oe.cd/atlp.
This presentation was uploaded with the author’s consent.
This presentation by Italy was made during the discussion “Alternatives to Leniency Programmes” held at the 22nd meeting of the OECD Global Forum on Competition on 7 December 2023. More papers and presentations on the topic can be found out at oe.cd/atlp.
This presentation was uploaded with the author’s consent.
This presentation by Daniel CRANE, Richard W. Pogue Professor of Law, University of Michigan, was made during the discussion “Out-of-Market Efficiencies in Competition Enforcement” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/omee.
This presentation was uploaded with the author’s consent.
This presentation by John DAVIES, Member, Competition Appeal Tribunal UK, was made during the discussion “Out-of-Market Efficiencies in Competition Enforcement” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/omee.
This presentation was uploaded with the author’s consent.
This presentation by Nancy ROSE, Head of the Department of Economics and Charles P. Kindleberger Professor of Applied Economics, Massachusetts Institute of Technology (MIT), was made during the discussion “Out-of-Market Efficiencies in Competition Enforcement” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/omee.
This presentation was uploaded with the author’s consent.
This presentation by Nicole ROSENBOOM, Principal, Oxera Consulting LLP, was made during the discussion “Out-of-Market Efficiencies in Competition Enforcement” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/omee.
This presentation was uploaded with the author’s consent.
This presentation by Anna TZANAKI, Lecturer in Law, University of Leeds, was made during the discussion “Serial Acquisitions and Industry Roll-ups” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/sair.
This presentation was uploaded with the author’s consent.
This presentation by Sha'ista GOGA, Director, Acacia Economics, was made during the discussion “Serial Acquisitions and Industry Roll-ups” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/sair.
This presentation was uploaded with the author’s consent.
This presentation by Ioannis KOKKORIS, Chair in Competition Law and Economics and Director, Centre for Commercial Law Studies, Queen Mary University of London, was made during the discussion “Serial Acquisitions and Industry Roll-ups” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/sair.
This presentation was uploaded with the author’s consent.
This presentation by the OECD Secretariat was made during the discussion “Serial Acquisitions and Industry Roll-ups” held at the 141st meeting of the OECD Competition Committee on 6 December 2023. More papers and presentations on the topic can be found out at oe.cd/sair.
This presentation was uploaded with the author’s consent.
This presentation by Simonetta VEZZOSO, Associate Professor, Economics Department, University of Trento, was made during the discussion “Competition and Innovation - The Role of Innovation in Enforcement Cases” held at the 141st meeting of the OECD Competition Committee on 5 December 2023. More papers and presentations on the topic can be found out at oe.cd/rbci.
This presentation was uploaded with the author’s consent.
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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