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		<title>Lessons from Europe: competition law in India's pharmaceutical sector</title>
		<description>Discuss Lessons from Europe: competition law in India's pharmaceutical sector</description>
		<link>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector</link>
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			<title>SASLaw says:</title>
			<link>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector#comment-906</link>
			<description><![CDATA[The challenges ahead for the new competition regime are not few and far between. Among those is the existence of potentially overlapping sectoral regulators for each of the industries like petroleum, electricity, insurance, telecom and securities. The need to sensitize members of the Competition Commission and the Tribunal to the techniques of modern competition analysis is immense. Putting the Competition Advocacy provision to extensive practice is therefore a must. Past experience with sectoral regulators has shown how lacunae in the Act allow for amateurish ideas and un-evolved interpretations of provisions and a narrow reading of the larger objective. For instance, this could bring down the role of the commission as a negotiator on "fair" pricing, by intervention in contractual disputes. Taking the case of co-operation between the two sectoral regulators – Telecom & Competition Commission: Interplay between the regulatory mechanism of Telecom and Competition - Telecom and competition policy would require close compatibility. The regulatory and competition issues are intertwined and would work well if the two bodies function like a conjugal family. What would hold them together and enable them to deal with domestic issues in tandem? The Telecom Regulator has to play the role of a conservative man who is less liberal ( more regulatory ) – till there is scope for more competition in the market and the industry is still evolving – market dominance / power remains in few hands; The Competition authority is like a vigilant woman of the family – intervening for frequent checks and balances – to work towards opening the market and discouraging concentration of power. The growing telecom sector is a good example of the co-operative work required - the two enforcement agencies need intense co-operation – keeping in mind the aims / objects of the policy. The regulator must respect competition principles - when the regulator allows the competition to open up with the help of the competition authority’s role as and when intervened – it will help the market get the right balance – benefiting consumers There is always an element / risk of abuse by industry – violating regulatory provisions –requiring competition authority to enforce its law. This is the time when utmost co-operation – smooth and constant dialogue between regulators and competition enforcers would get the balance right ! Working together is the key to their success !!]]></description>
			<dc:creator>SASLaw</dc:creator>
			<pubDate>Wed, 30 Sep 2009 13:52:06 +0000</pubDate>
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			<title>SASLaw says:</title>
			<link>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector#comment-905</link>
			<description><![CDATA[Some of the recent cases that raised competition issues with Drug Makers are – Anti-Competitive terms of Licenses - In the pharmaceutical industry, “Gilead” signed voluntary non-exclusive licenses with companies in South Africa and notably eleven generic manufacturers in India for the production and sale of an HIV-AIDS drug, ‘Tenofovir disoproxil fumarate’ ( referred here as TENOFOVIR) as well as product patents on Emtricitabine, and combinations of the two. The terms in these licenses are generally standard- with a payment of a royalty rate of 5%, meeting quality standards of the WHO and/or US FDA, and the grant-back licenses on improvements, modifications and derivatives. In a blatant attempt to get market power, Gilead’s Licensing terms had certain anti-competitive features of the license including the requirement of royalty payment where Gilead does not hold a patent, prohibition of supply of active pharmaceutical ingredients (APIs) to firms/markets not approved by Gilead and lastly, that licensed sellers were required to purchase the APIs from Gilead affiliated licensed suppliers. These terms imposing restrictions / prohibition of supply etc. are an attempt to (hypothetically speaking) eliminate competition in the market and hence anti-competitive as per law. Evergreening of patents - Can the recent practices of pharma companies of over-hyping the merits of the newer versions of the drug be considered anti-competitive and stopped? As of now, the fear of elimination of older drugs from the market maybe non-existent in India where there isn’t much of a health insurance trend; there will always be a very large percentage of the population that just cannot afford the newer drug and doctors will be compelled to prescribe the cheaper (older) versions, thereby keeping these in the market. But will this always be the case? If not, we are back once again to the wisdom of having provisions like 3(d) of the Indian Patent Act, that prevent evergreening by denying patents to incremental innovations that do not otherwise demonstrate enhanced efficacy. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean they can abuse these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This would be considered as anti-competitive. Unfortunately however, this goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible. Marketing Exclusivity Recently, the Indian drugmaker, Glenmark pharmaceuticals has received first-to-file status for three of its abbreviated new drug applications ( ANDA ), namely, Zeita ( generic name ezetimibe ), Tarka ( trandolapril + verapamil ) and cutivate ( fluticasone lotion ). First to file and first to invent are legal concepts that define who has the right to the grant of a patent for an invention. The first to file system is used in the majority of countries, with the notable exception of the United States, which operates a first to invent system. In a first to file system, the right to the grant of a patent for a given invention lies with the first person to file a patent application for protection of that invention, regardless of the date of actual invention. With this first-to-file status comes the advantage of a 180-days marketing exclusivity ( from the date of approval of the ANDA ). During this period the US food & drug Administration may not approve another ANDA, for such a generic product after the approval. During this period, the company can garner huge profits since they will not face any competition for half a year and the generic version will be sold at 70-80% of the branded product price. Although litigations are at various stages for all the three products but if Glenmark wins, the company will gain an edge over the market in the six months exclusivity time, which is much sought out for. Although the marketing exclusivity granted is legally enforceable, any anti-competitive terms involving restriction on price, vendor etc. to exploit consumers / competitors will come into the trappings of competition law curbing such restrictive terms and punishing the entity for their anti-competitive conduct.]]></description>
			<dc:creator>SASLaw</dc:creator>
			<pubDate>Wed, 30 Sep 2009 13:50:10 +0000</pubDate>
			<guid>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector#comment-905</guid>
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			<title>Ravi Prakash says:</title>
			<link>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector#comment-739</link>
			<description><![CDATA[it would also be interesting to note that how CCI will react to the market behaviour of some core infrastructure sector such as CEMENT & Steel...]]></description>
			<dc:creator>Ravi Prakash</dc:creator>
			<pubDate>Tue, 08 Sep 2009 07:35:32 +0000</pubDate>
			<guid>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector#comment-739</guid>
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		<item>
			<title>Ravi Prakash says:</title>
			<link>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector#comment-738</link>
			<description><![CDATA[I think, Indian competition commission will hit & in process to hit aviation sector. Even pharmaceutical sector is also at very critical stage.. but CCI has already issued a notice to KINGFISHER & JETAIRLINES for their practice ...]]></description>
			<dc:creator>Ravi Prakash</dc:creator>
			<pubDate>Tue, 08 Sep 2009 07:32:47 +0000</pubDate>
			<guid>http://www.legallyindia.com/20090807126/Legal-opinions/lessons-from-europe-competition-law-in-indias-pharmaceutical-sector#comment-738</guid>
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