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 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 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 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 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 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
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 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 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 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 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 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 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 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
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 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 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 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 Pedro CARO DE SOUSA from the OECD Competition Division 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 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 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 Martin WENZL from the OECD Health Division 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 from Italy 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 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
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This presentation by Margaret KYLE, Professor of Economics, MINES Paris Tech, 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 from the EU 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.
Counter Point - III: Anti-competitive Practices in Pharmaceutical Sector -Cas...KK SHARMA LAW OFFICES
As done in some of the previous issues of Competition Law Reporter (CLR), continuing with the series on dissenting and separate orders of different members of the Competition Commission of India (Commission) in some of the cases, in
this write up the focus is on an old case filed before erstwhile MRTPC and transferred to the Commission under the scheme, provided under the Competition Act, 2002 (the Act ), to deal with such cases on repeal ofMRTPC Act, 1969 and
commencement of enforcement of the Act w.e.f.May 20,2009. This was followed by similar informations filed before the Commission alleging anticompetitive practices in pharmaceutical distribution and retail sector. Various studies have documented the prevalence of a number of anticompetitive practices in the pharmaceutical sector which are so deeply entrenched that even pharmaceutical
giants have to succumb to them. The reason of successful perpetuation of these anticompetitive practices is that the players responsible for initiation of these practices and their continuation have not only have a wide reach across the
country but are extremely well organised. Interestingly,most of these informations landed before the Commission because of the infighting amongst members of the associations responsible for these practices orwhen one or some of the office bearers of these associations became too domineering with other ordinary members. The author, who as the first Director General of the Commission put the competition
law investigation framework in place and supervised the very first investigations, looks at the different orders passed by the Commission and its members and the way similar issues were handled in other jurisdictions worldwide.
This presentation by Valérie Paris, Senior Health Policy Analyst, OECD, was made during the discussion “Excessive prices in pharmaceutical markets" held at the OECD Competition Open Day on 27 February 2019. More documents and presentations on this topic can be found at oe.cd/comp-open-day-19.
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ERMS – RECOMMENDATIONS 2005 – KEY CHANGES
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NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
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PHARMACOVIGILANCE OF VETERINARY MPS
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ICH GUIDELINES
GPvP GUIDELINES
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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 Pedro CARO DE SOUSA from the OECD Competition Division 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 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 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 Martin WENZL from the OECD Health Division 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 from Italy 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 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 Andrea Pezzoli, Director General for Competition, Autorità garante della concorrenza e del mercato, was made during the discussion “Excessive prices in pharmaceutical markets" held at the OECD Competition Open Day on 27 February 2019. More documents and presentations on this topic can be found at oe.cd/comp-open-day-19.
This presentation by Margaret KYLE, Professor of Economics, MINES Paris Tech, 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 from the EU 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.
Counter Point - III: Anti-competitive Practices in Pharmaceutical Sector -Cas...KK SHARMA LAW OFFICES
As done in some of the previous issues of Competition Law Reporter (CLR), continuing with the series on dissenting and separate orders of different members of the Competition Commission of India (Commission) in some of the cases, in
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giants have to succumb to them. The reason of successful perpetuation of these anticompetitive practices is that the players responsible for initiation of these practices and their continuation have not only have a wide reach across the
country but are extremely well organised. Interestingly,most of these informations landed before the Commission because of the infighting amongst members of the associations responsible for these practices orwhen one or some of the office bearers of these associations became too domineering with other ordinary members. The author, who as the first Director General of the Commission put the competition
law investigation framework in place and supervised the very first investigations, looks at the different orders passed by the Commission and its members and the way similar issues were handled in other jurisdictions worldwide.
This presentation by Valérie Paris, Senior Health Policy Analyst, OECD, was made during the discussion “Excessive prices in pharmaceutical markets" held at the OECD Competition Open Day on 27 February 2019. More documents and presentations on this topic can be found at oe.cd/comp-open-day-19.
Medicines Verification Systems in Europe – a perspective from wholesale distr...László Árvai
The Falsified Medicines Directive and its Delegated Regulation on Safety Features
European Medicines Verification Organisation (EMVO) and the roll-out of National Medicines Verification Systems
GIRP and wholesale distributors perspectives on medicines verification systems
Impact on the actors in the supply chain
TIMELINE
PHARMACOVIGILANCE STAKEHOLDERS
ERMS – RECOMMENDATIONS 2005 – KEY CHANGES
2006 CONSULTATIONS – 2008 PROPOSALS
NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
PHARMACOVIGILANCE OF HUMAN MPs
PHARMACOVIGILANCE OF VETERINARY MPS
MILESTONES 2011-2012
REGULATION (EU) 520/2012
ICH GUIDELINES
GPvP GUIDELINES
MILESTONES – FURTHER DEVELOPMENT
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The Regulatory Policy Institute, based in Oxford, holds an annual conference on competition and regulation. At this year’s conference, OHE’s Jon Sussex described how the prescription medicines market in England is regulated for innovation.
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Competition and Pharmaceuticals - Sabine Vogler - 2014 OECD Global Forum on Competition
1. Liberalization in the pharmacy sector
Sabine Vogler
WHO Collaborating Centre for
Pharmaceutical Pricing and Reimbursement Policies
Gesundheit Österreich / Austrian Health Institute
Head of Pharma Team
PPRI Project Manager
Head of WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies
OECD Global Forum on Competition:
Competition Issues in the Distribution of Pharmaceuticals
Paris, 28 February 2014
2. Disclaimer and acknowledgements
The information and data provided in this presentation was
collected and analyzed by the WHO Collaborating Centre for
Pharmaceutical Pricing and Reimbursement Policies. This is not a
publication of WHO. The presenter is responsible for the views
expressed in this presentation, and they do not necessarily
represent the decisions and policies of the World Health
Organization.
Credits go to the members of the team members in the WHO
Collaborating Centre for Pharmaceutical Pricing and
Reimbursement Policies, particularly to Danielle Arts, Katharina
Habimana and Claudia Habl who worked with the presenter on
the issue of distribution of medicines and liberalization in the
pharmacy sector.
Information used from this presentation has to be correctly
quoted. Commercial exploitation is forbidden.
2
3. Outline
» Components of liberalization in community
pharmacy in European countries
» Impact of liberalization in community
pharmacy on medicine prices
» Impact of liberalization in community
pharmacy on accessibility of medicines
» Conclusions
3
4. Methods
» Experiences of European countries which
liberalized the pharmacy sector
» Literature review as of December
2013, including grey literature
» Two previous studies on this topic
4
5. Components of liberalization in com. pharmacy
» Regulation related to the establishment of
new pharmacies
» Ownership regulation
» Sale of OTC medicines outside pharmacies
5
6. Expectations linked to liberalization in c. pharmacy
» Increased accessibility
(more pharmacies and OTC retailers, opening
hours, product range/services)
» Lower medicine prices
» Concerns about deterioration in quality of
pharmacy services
6
7. Impact of liberalization on medicine prices
European countries:
» Medicine prices are usually regulated at all price
levels, at least for reimbursable medicines –
independently from the extent of liberalization in
pharmacy
» Impact of liberalization could only be expected for
areas where there is free pricing non-reimbursable/
OTC (Over-the-Counter) medicines
» Few price studies on OTC medicines
» The identified price surveys could not confirm a
decrease in OTC medicine prices after a liberalization
in the community pharmacy
7
8. Impact of liberalization on accessibility/1
» Increase in the number of pharmacies (and OTC
retailers) immediately after liberalization
Sweden
1300
1200
1100
1000
900
800
700
1999
2007
2009
number of pharmacies
2011
2012
Norway
750
700
650
600
550
500
450
400
350
300
250
1990 1995 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
8
9. Impact of liberalization on accessibility/2
» Little or no improved accessibility in remote areas
»
Pharmacies: 6% of the new 330 pharmacies are located in areas of
medium accessibility and no new pharmacies in areas of low or very
low accessibility
»
OTC retailers: 4% of the new OTC retailers in areas of low or very
low accessibility
» Other incentives and regulation are required for rural
areas
» Indications for longer opening hours
» Vertical integration indications for an alignment of
the product range to owners
» Indications for limited product range
9
10. Conclusions
» Liberalization in the pharmacy sector does not always
fully meet the expectations
» No evidence for price competition of non-regulated
OTC medicines in the surveyed countries (all of them
with publicly funded HC)
» Accessibility in terms of the number of pharmacies
has improved, but adverse effects related to equitable
access might occur
» Some findings (e.g. distortion of competition due to
unbalanced market power, uneven accessibility of
medicines) are likely be relevant for countries with
less regulated or non-regulated pharmacy sector
10
11. Thank you for your attention!
Sabine Vogler
Stubenring 6
1010 Vienna
T: +43 1 515 61-147
F: +43 1 513 84 72
E-mail: sabine.vogler@goeg.at
www.goeg.at
http://whocc.goeg.at