Intellectual Property and Pharmaceuticals
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| − | + | '''Global Medicines Crisis''' | |
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| + | This page provides an overview of the barriers that the prevailing intellectual property regime presents to access to quality affordable medicines in developing countries, with links to further resources and to the PHM_Oz [[PHM Oz IP Project |Global Medicines Crisis]] campaign page. | ||
| + | This is a major public health problem but one which many people find difficult to understand. This web page aims to provide some introductory commentary about these issues with links to more detailed information. It is a work in progress and we hope that interested people will contribute their ideas as it develops. (If you are happy to join us in developing this resource please contact Sally[at]phmoz.org for login details.) | ||
| + | '''Barriers to delivering quality affordable medicines''' | ||
The barriers to delivering quality affordable medicines in developing countries when and where they are needed constitute a global public health crisis. | The barriers to delivering quality affordable medicines in developing countries when and where they are needed constitute a global public health crisis. | ||
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* barriers to accessing life saving drugs because of price | * barriers to accessing life saving drugs because of price | ||
* failure to develop [[Drug Development for Neglected Diseases|drugs for neglected diseases]] because the markets are judged to be insufficiently profitable | * failure to develop [[Drug Development for Neglected Diseases|drugs for neglected diseases]] because the markets are judged to be insufficiently profitable | ||
| − | * widespread peddling of counterfeit and substandard medicines because of lack of regulation of production and distribution | + | * widespread peddling of [http://www.who.int/mediacentre/factsheets/fs275/en/index.html counterfeit] and substandard medicines because of lack of regulation of production and distribution |
* [[Quality Use of Medicines|inappropriate use of valuable drugs]] because of lack of quality assurance, lack of academic detailing, high pressure marketing (without compensatory academic detailing) and consumer pressure on prescribers associated with ‘direct to consumer’ advertising. | * [[Quality Use of Medicines|inappropriate use of valuable drugs]] because of lack of quality assurance, lack of academic detailing, high pressure marketing (without compensatory academic detailing) and consumer pressure on prescribers associated with ‘direct to consumer’ advertising. | ||
These problems can be traced, in part, to: | These problems can be traced, in part, to: | ||
| − | * price barriers associated with restrictive intellectual property laws and the fierce efforts of big pharma to maintain tight IP controls (see the [[South Africa, Pharmaceuticals and Intellectual Property|South African case]]; see also [[Thailand, Pharmaceuticals and Intellectual Property|Thailand]] and [[Novartis case in India|Novartis]]) | + | * price barriers associated with restrictive intellectual property laws and the fierce efforts of big pharma to maintain tight IP controls (see the [[South Africa, Pharmaceuticals and Intellectual Property|South African case]]; see also [[Thailand, Pharmaceuticals and Intellectual Property|Thailand and Abbott]] and [[Novartis case in India|Novartis in India]] and current moves in [[Brazil]].) |
| − | * under investment in the development of [[Drug Development for Neglected Diseases|drugs for neglected diseases]], because of the degree to which drug development is tied to rich world markets | + | * under-investment in the development of [[Drug Development for Neglected Diseases|drugs for neglected diseases]], because of the degree to which drug development is tied to rich world markets |
* dubious marketing practices in order to maintain drug company profits often through inappropriate use | * dubious marketing practices in order to maintain drug company profits often through inappropriate use | ||
* poor regulation of drug quality, which reflects failure of national regulation (see [[Manufacture, Distribution, Sale and Marketing of Pharmaceuticals]]); | * poor regulation of drug quality, which reflects failure of national regulation (see [[Manufacture, Distribution, Sale and Marketing of Pharmaceuticals]]); | ||
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These features reflect a failure of governance; a [[Global Regime of Pharmaceutical Governance|failure in the governance, regulation and accountability of the pharmaceuticals industry]] and of the total system from pharmaceuticals development and delivery to medication access and usage. The market is failing and there has been no corrective regulation. It is a governance failure both within countries and globally. | These features reflect a failure of governance; a [[Global Regime of Pharmaceutical Governance|failure in the governance, regulation and accountability of the pharmaceuticals industry]] and of the total system from pharmaceuticals development and delivery to medication access and usage. The market is failing and there has been no corrective regulation. It is a governance failure both within countries and globally. | ||
| − | Recent high profile cases illustrate different aspects of the way the present governance regime is dominated by big pharma and the national governments which act on its behalf. See the [[South Africa, Pharmaceuticals and Intellectual Property|South African case]], [[Thailand, Pharmaceuticals and Intellectual Property|Thailand case]] and [[Novartis case in India]]). | + | '''Country case studies: big pharma vs national governments''' |
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| + | Recent high profile cases illustrate different aspects of the way the present governance regime is dominated by big pharma and the national governments which act on its behalf. See the [[South Africa, Pharmaceuticals and Intellectual Property|South African case]], [[Thailand, Pharmaceuticals and Intellectual Property|Thailand case]] and [[Novartis case in India]]). See also [[Brazil | Brazil]]. | ||
See also [[Economics of the Pharmaceutical Industry]]. | See also [[Economics of the Pharmaceutical Industry]]. | ||
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| + | '''Towards strategies for reform''' | ||
Reform of national and global governance, towards a regime that will develop and deliver medications where, when and how they can do most good will face strong opposition from vested interests and may involve, among other things, quite radical changes to intellectual property regulation globally. To achieve such changes will require the mobilisation of civil society, national governments and international organisations. Australia will be a significant player in such a process due to the strength of its biomedical industry and its role in drug trials. | Reform of national and global governance, towards a regime that will develop and deliver medications where, when and how they can do most good will face strong opposition from vested interests and may involve, among other things, quite radical changes to intellectual property regulation globally. To achieve such changes will require the mobilisation of civil society, national governments and international organisations. Australia will be a significant player in such a process due to the strength of its biomedical industry and its role in drug trials. | ||
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Building a constituency for change involves working with different stakeholders and different constituencies on issues of particular concern to them on; finding how much change they can achieve and canvassing their support for larger scale change. This can have a kind of snowballing effect; building the understanding, concern and commitment of a widening circle, in the course of working through particular aspects. | Building a constituency for change involves working with different stakeholders and different constituencies on issues of particular concern to them on; finding how much change they can achieve and canvassing their support for larger scale change. This can have a kind of snowballing effect; building the understanding, concern and commitment of a widening circle, in the course of working through particular aspects. | ||
| − | PHM Oz believes that the patenting and licensing practices of independent researchers might be just such an issue; important in its own right but also a potential bridging issue; bridging more networks into the movement for change. PHM Oz is keen to work with Australian researchers and research funders to implement more widely the kinds of patenting and licensing practices recommended by the [[WHO Commission on Intellectual Property Rights, Innovation and Public Health]]. These are broadly directed to keeping intellectual property generated through public funds in the public domain. | + | PHM Oz believes that the patenting and licensing practices of independent researchers might be just such an issue; important in its own right but also a potential bridging issue; bridging more networks into the movement for change. PHM Oz is keen to work with Australian researchers and research funders to implement more widely the kinds of patenting and licensing practices recommended by the [[WHO Commission on Intellectual Property Rights, Innovation and Public Health]]. These are broadly directed to keeping intellectual property generated through public funds in the public domain. See [[Alternative approaches to IP regulation | Alternative approaches to IP regulation]] |
As a preliminary step we are keen to find out exactly what kinds of patenting and licensing policies and practices are current among research institutes, universities and research funders in Australia. | As a preliminary step we are keen to find out exactly what kinds of patenting and licensing policies and practices are current among research institutes, universities and research funders in Australia. | ||
| − | + | [mailto:info@phmoz.org Write to PHM Oz] if you are interested in finding out more. | |
This could be an excellent opportunity for honors or postgraduate students in public health and other relevant disciplines. | This could be an excellent opportunity for honors or postgraduate students in public health and other relevant disciplines. | ||
| − | Linked pages | + | '''Linked pages''' <br> |
: [[Novartis case in India]] | : [[Novartis case in India]] | ||
: [[South Africa, Pharmaceuticals and Intellectual Property]] | : [[South Africa, Pharmaceuticals and Intellectual Property]] | ||
: [[Thailand, Pharmaceuticals and Intellectual Property]] | : [[Thailand, Pharmaceuticals and Intellectual Property]] | ||
| + | : [[Brazil]] | ||
: [[WHO Commission on Intellectual Property Rights, Innovation and Public Health]] | : [[WHO Commission on Intellectual Property Rights, Innovation and Public Health]] | ||
: [[TRIPS to Doha to Bilateral FTAs]] | : [[TRIPS to Doha to Bilateral FTAs]] | ||
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: [[Drug Development for Neglected Diseases]] | : [[Drug Development for Neglected Diseases]] | ||
: [[Economics of the Pharmaceutical Industry]] | : [[Economics of the Pharmaceutical Industry]] | ||
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: [[Global Regime of Pharmaceutical Governance]] | : [[Global Regime of Pharmaceutical Governance]] | ||
| + | : [[Compulsory Licensing]] | ||
| + | : [[Alternative approaches to IP regulation]] | ||
| + | : [[The Gates Foundation and Essential Medicines]] | ||
Latest revision as of 06:19, 16 December 2007
Global Medicines Crisis
This page provides an overview of the barriers that the prevailing intellectual property regime presents to access to quality affordable medicines in developing countries, with links to further resources and to the PHM_Oz Global Medicines Crisis campaign page.
This is a major public health problem but one which many people find difficult to understand. This web page aims to provide some introductory commentary about these issues with links to more detailed information. It is a work in progress and we hope that interested people will contribute their ideas as it develops. (If you are happy to join us in developing this resource please contact Sally[at]phmoz.org for login details.)
Barriers to delivering quality affordable medicines
The barriers to delivering quality affordable medicines in developing countries when and where they are needed constitute a global public health crisis.
The crisis is manifest in:
- barriers to accessing life saving drugs because of price
- failure to develop drugs for neglected diseases because the markets are judged to be insufficiently profitable
- widespread peddling of counterfeit and substandard medicines because of lack of regulation of production and distribution
- inappropriate use of valuable drugs because of lack of quality assurance, lack of academic detailing, high pressure marketing (without compensatory academic detailing) and consumer pressure on prescribers associated with ‘direct to consumer’ advertising.
These problems can be traced, in part, to:
- price barriers associated with restrictive intellectual property laws and the fierce efforts of big pharma to maintain tight IP controls (see the South African case; see also Thailand and Abbott and Novartis in India and current moves in Brazil.)
- under-investment in the development of drugs for neglected diseases, because of the degree to which drug development is tied to rich world markets
- dubious marketing practices in order to maintain drug company profits often through inappropriate use
- poor regulation of drug quality, which reflects failure of national regulation (see Manufacture, Distribution, Sale and Marketing of Pharmaceuticals);
- inappropriate prescribing partly linked to high pressure marketing including various forms of DTC marketing (including disease mongering) (see Quality Use of Medicines)
- less than effective utilisation patterns by consumers partly because of the lack of investment in consumer education for appropriate medication use
These features reflect a failure of governance; a failure in the governance, regulation and accountability of the pharmaceuticals industry and of the total system from pharmaceuticals development and delivery to medication access and usage. The market is failing and there has been no corrective regulation. It is a governance failure both within countries and globally.
Country case studies: big pharma vs national governments
Recent high profile cases illustrate different aspects of the way the present governance regime is dominated by big pharma and the national governments which act on its behalf. See the South African case, Thailand case and Novartis case in India). See also Brazil.
See also Economics of the Pharmaceutical Industry.
Towards strategies for reform
Reform of national and global governance, towards a regime that will develop and deliver medications where, when and how they can do most good will face strong opposition from vested interests and may involve, among other things, quite radical changes to intellectual property regulation globally. To achieve such changes will require the mobilisation of civil society, national governments and international organisations. Australia will be a significant player in such a process due to the strength of its biomedical industry and its role in drug trials.
This is a big challenge but every long journey begins with a single step.
Building a groundswell, a constituency for change, will involve improving access to and disseminating information about:
- the global medications crisis; see the Four Pillars of Pharmaceutical Policy, TRIPS to Doha to Bilateral FTAs, and Donations, Differential Prices and Charity
- the structures and dynamics of pharmaceuticals governance globally and nationally;
- the range of options which are available for regulatory reform and the kinds of campaigns which might be needed to implement them;
This is one of the purposes of this website.
Building a constituency for change involves working with different stakeholders and different constituencies on issues of particular concern to them on; finding how much change they can achieve and canvassing their support for larger scale change. This can have a kind of snowballing effect; building the understanding, concern and commitment of a widening circle, in the course of working through particular aspects.
PHM Oz believes that the patenting and licensing practices of independent researchers might be just such an issue; important in its own right but also a potential bridging issue; bridging more networks into the movement for change. PHM Oz is keen to work with Australian researchers and research funders to implement more widely the kinds of patenting and licensing practices recommended by the WHO Commission on Intellectual Property Rights, Innovation and Public Health. These are broadly directed to keeping intellectual property generated through public funds in the public domain. See Alternative approaches to IP regulation
As a preliminary step we are keen to find out exactly what kinds of patenting and licensing policies and practices are current among research institutes, universities and research funders in Australia.
Write to PHM Oz if you are interested in finding out more.
This could be an excellent opportunity for honors or postgraduate students in public health and other relevant disciplines.
Linked pages
- Novartis case in India
- South Africa, Pharmaceuticals and Intellectual Property
- Thailand, Pharmaceuticals and Intellectual Property
- Brazil
- WHO Commission on Intellectual Property Rights, Innovation and Public Health
- TRIPS to Doha to Bilateral FTAs
- Four Pillars of Pharmaceutical Policy
- Donations, Differential Prices and Charity
- Drug Development for Neglected Diseases
- Economics of the Pharmaceutical Industry
- Global Regime of Pharmaceutical Governance
- Compulsory Licensing
- Alternative approaches to IP regulation
- The Gates Foundation and Essential Medicines
