Proceedings of Delhi Convention on Pharmaceuticals and People
10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.
The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.
Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.
Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.
Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.
Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.
Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.
Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.
Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.
1.
Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.
Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.
Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.
D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.
Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.
The convention adopted a resolution after debate and suggestions emerged from the participants.
Draft Resolution
The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.
Formulation of a National Pharmaceutical Policy
1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.
Self Reliant Production and Distribution
Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.
Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:
Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.
Fake/Counterfeit Medicines:
The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.
Irrational Medicines:
The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:
As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.
Indian Patent Act
The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.
Unethical Promotion:
The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.
Programme of Action
Based on the above demands the convention decides to take up the following activities:
a) Campaign Committees be formed in all States.
b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.
c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.
d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.
e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.
f) Organise Public hearing on medicine prices and irrational medicines.
g) Discussion with the concerned Ministries to be sought for pursuing the above demands.
h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.
i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.
j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.
k) Campaign on unethical promotion among the medical community
l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.
Proceedings of Delhi Convention on Pharmaceuticals and People
10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.
The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.
Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.
Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.
Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.
Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.
Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.
Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.
Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.
1.
Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.
Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.
Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.
D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.
Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.
The convention adopted a resolution after debate and suggestions emerged from the participants.
Draft Resolution
The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.
Formulation of a National Pharmaceutical Policy
1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.
Self Reliant Production and Distribution
Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.
Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:
Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.
Fake/Counterfeit Medicines:
The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.
Irrational Medicines:
The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:
As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.
Indian Patent Act
The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.
Unethical Promotion:
The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.
Programme of Action
Based on the above demands the convention decides to take up the following activities:
a) Campaign Committees be formed in all States.
b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.
c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.
d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.
e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.
f) Organise Public hearing on medicine prices and irrational medicines.
g) Discussion with the concerned Ministries to be sought for pursuing the above demands.
h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.
i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.
j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.
k) Campaign on unethical promotion among the medical community
l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.
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