IP Disputes in Medicine

Thursday, December 07, 2006

Netherlands Issues Non-paper

by Ben Krohmal

Day four of the IGWG meeting is now underway. A revised version of the document "Elements of a Global Strategy and Plan of Action" was released at 7:30am Geneva time. The new version is divided into two separate papers: "Elements of the global strategy and plan of action: Elements of a Global Strategy" and "Elements of a global strategy and plan of action: Elements of a plan of action" (new version not available online, old version is here). Now in the afternoon session, The Netherlands has obtained approval from the EU to submit a non-paper on the "Elements" document(s) that is now being distributed by the Secretariat as the meeting adjourns. The non-paper addresses recommendations from the CIPIH report that are absent in the "Elements" documents. The text appears below:

Non Paper of The Netherlands

A/PHI/IGWG/1/Conf.Paper No 1

7 December 2006

Elements of a global strategy and plan of action

Elements of a plan of action

2) Prioritizing research and development needs

Extract from text


bullet 4: conduct research on affordable [to be defined]

definition should refer to the definition of ‘affordable’ in Essential medicines (affordable to people in their communities)

Elaboration of the above areas of action should consider recommendations …

include CIPIH recommendations 2.7, 2.8

Absence of reference to medicines as global public good

Include reference.

Absence of reference to gaps in translational research

Include reference

3) Promoting R&D

Elaboration of the above areas of action should consider recommendations …

include CIPIH recommendations 3.7 (open source), 4.5, 5.7 (International Conf on Harmonisation)

Elaboration of the above areas of action should consider recommendations should consider… and 3.6

Request specific action: WHO should actively undertake work on the issues in 3.6 (R&D treaty)

4) Building innovative capacity

preamble para: In further elaborating this element of the plan, activities proposed should take into consideration the work and mandates of other agencies such as WIPO and WTO

Request specific action: WHO should not shy away from making recommendations to these two agencies

bullet 5: Promote patent pools of upstream technologies

include reference to downstream patent pools

5) Transfer of technology to improve innovative capacity

bullet 4: Article 66.2 of TRIPS

include a reference to paragraph 7 of the Doha Declaration

In elaborating the plan for this area of work consideration should be given to taking advantage of work underway in universities, research institutions and PPPs

include a reference to the Philadelphia Consensus Statement, the recent call by prominent scientists and student groups which outlines how universities can improve access to medicines and transfer of knowledge to the developing world by changing their licensing policies and intellectual property rights. It may be useful for the IGWG to consider the development of best practices models for such licensing.

Absence of references

As with other sections include at end references to specific CIPIH recommendations, including 5.4, 5.8 (clinical trials)

6) Management of intellectual property

preamble para: The plan of action should address the development of capacities for the management of intellectual property and technologies in developing countries

Include the caveat expressed in CIPIH recommendation 5.3 “fully taking into account the needs of recipient countries and their public health policies”

bullet 1: enact legislation in developed and developing countries for application for the flexibilities provided for in TRIPS

Strengthen text with reference to CIPIH recommendation 4.13 including “the right of governments to use compulsory licensing”

bullet 2: establish or work within national and/or regional institutional frameworks to promote and manage intellectual property

Remove “to promote”

bullet 5: Strengthen education and training in management of IP

Include the caveat expressed in CIPIH recommendation 5.3 “fully taking into account the needs of recipient countries and their public health policies”

bullet 6: assure that bilateral trade agreements do not seek to incorporate “TRIPS +” protection

Strengthen text with reference to CIPIH recommendation 4.21 including “that ministries of health be properly represented in the negotiation”

Absence of references

As with other sections include at end references to specific CIPIH recommendations

7) Improving delivery and access

bullet 7: Devise ways to curb counterfeiting of medicines and technology

Remove. Not a CIPIH recommendation. Counterfeiting is most effectively combated by ensuring that high quality medicines are made affordable

bullet 11: continue to consider price of treatment for communicable diseases particularly of secondline drugs for HIV/AIDS

Refer to original wording of CIPIH recommendation 4.8 “Continuing consideration needs to be given…”

Elaboration of the above areas of action should consider recommendations …

Include references to CIPIH recommendations 4.1, 4.2, 4.3, 4.7, 4.8, 4.9, 4.15, 4.16, 4.19 (parallel importing), 4.20, 4.23 and 4.27

8) Ensuring sustainable financing mechanisms

bullet 4: establish a funding mechanism for research and development for neglected diseases, while avoiding duplication with existing programs

Remove “while avoiding duplication with existing programs”. This gives the misleading impression that there are extensive existing programmes.

Absence of references

As with other sections include at end references to specific CIPIH recommendations


1. Text of CIPIH Recommendations Excluded from “Elements of a global strategy and plan of action” (A/PHI/IGWG/1/4)

  • 3.5 Governments should continue to develop forms of advance

purchase schemes which may contribute to moving later stage vaccines,

medicines and diagnostics as quickly as possible through development

to delivery.

  • 3.7 Practical initiatives that would motivate more scientists to

contribute to this field through “open source” methods should be


  • 4.1 Governments need to invest appropriately in the health delivery

infrastructure, and in financing the purchase of medicines

and vaccines through insurance or other means, if existing and new

products are to be made available to those in need of them. Political

commitment is a prerequisite for bringing about a sustained improvement

in the delivery infrastructure and health outcomes. Health systems

research to inform policy-making and improve delivery is also

important. The integration of traditional medicine networks with

formal health services should be encouraged.

  • 4.2 Developing countries should create incentives designed to

train and retain health-care workers in employment.

  • 4.3 Developed countries should support developing countries’ efforts

to improve health delivery systems, inter alia, by increasing the

supply of their own trained health-care workers.

  • 4.6 All companies should adopt transparent and consistent pricing

policies, and should work towards reducing prices on a more

consistent basis for low and lower middle income developing countries.

Products, whether originator’s or generic, should be priced

equitably, not just in sub-Saharan Africa and least developed countries,

but also in low and lower middle income countries where there

are a vast number of poor patients.

  • 4.7 For noncommunicable diseases, governments and companies

should consider how treatments, which are widely available in developed

countries, can be made more accessible for patients in developing


  • 4.8 Continuing consideration needs to be given to the prices of

treatments for communicable diseases, particularly of second-line

drugs for HIV/AIDS treatment.

  • 4.9 Governments of low and middle income countries where

there are both rich and poor patients should formulate their funding

and price regulation with a view to providing access to poor people.

  • 4.10 Governments need to prioritize health care in their national

agendas and, given the leverage to determine prices that patents confer,

should adopt measures to promote competition and ensure that

pricing of medicines is consistent with their public health policies.

Access to drugs cannot depend on the decisions of private companies

but is also a government responsibility.

  • 4.11 Corporate donation programmes can be of great value in a

number of fields in collaboration with the actions of governments

and nongovernmental organizations. However, addressing health

needs in developing countries requires more structured and sustainable

actions by governments and other parties that stimulate accessibility

to products, while generating new treatments and products

adapted to the needs of developing countries.

  • 4.12 Governments should remove any tariffs and taxes on healthcare

products, where appropriate, in the context of policies to enhance

access to medicines. They should also monitor carefully the

supply and distribution chain to minimize costs that could adversely

influence the prices of medicines.

  • 4.14 Developed countries, and other countries, with manufacturing

and export capacity should take the necessary legislative steps to allow

compulsory licensing for export consistent with the TRIPS agreement.

  • 4.15 The WTO decision agreed on 30 August 2003, for countries

with inadequate manufacturing capacity, has not yet been used by

any importing country. Its effectiveness needs to be kept under

review and appropriate changes considered to achieve a workable

solution, if necessary.

  • 4.18 Developed countries and the WTO should take action to ensure

compliance with the provisions of Article 66.2 of the TRIPS

agreement, and to operationalize the transfer of technology for pharmaceutical

production in accordance with paragraph 7 of the Doha

Declaration on the TRIPS Agreement and Public Health.

  • 4.19 The restriction of parallel imports by developed countries is

likely to be beneficial for affordability in developing countries. Developing

countries should retain the possibilities to benefit from differential

pricing, and the ability to seek and parallel import lower

priced medicines.

  • 4.21 In bilateral trade negotiations, it is important that governments

ensure that ministries of health be properly represented in the

negotiation, and that the provisions in the texts respect the principles

of the Doha Declaration. Partners should consider carefully any

trade-offs they may make in negotiation.

  • 4.22 Governments and concerned international organizations

should promote new purchasing mechanisms to stimulate the supply

of affordable new products and to enhance the number of suppliers

in order to provide a more competitive environment.

  • 4.24 Countries should provide in national legislation for measures

to encourage generic entry on patent expiry, such as the “early working”

exception, and more generally policies that support greater

competition between generics, whether branded or not, as an effective

way to enhance access by improving affordability. Restrictions

should not be placed on the use of generic names.

  • 4.25 Developing countries should adopt or effectively implement

competition policies in order to prevent or remedy anti-competitive

practices related to the use of medicinal patents, including the use of

pro-competitive measures available under intellectual property law.

  • 4.26 Bilateral trade agreements should not seek to incorporate

TRIPS-plus protection in ways that may reduce access to medicines

in developing countries.

  • 4.27 Governments should take action to avoid barriers to legitimate

competition by considering developing guidelines for patent

examiners on how properly to implement patentability criteria and,

if appropriate, consider changes to national patent legislation.

  • 5.5 Developed countries should comply with their obligations

under article 66.2 of the TRIPS Agreement and paragraph 7 of the

Doha Declaration.

  • 5.7 The process of the International Conference on Harmonisation

currently lacks immediate relevance to the needs of many developing

countries, but those countries should maintain their participation in

the process. In the meantime, developing country governments and

regulatory institutions should give support to regional initiatives,

tailored to the current capacities of their member countries, which

offer more scope for lifting standards over time, exploiting comparative

advantages, avoiding duplication, sharing information and facilities,

and promoting appropriate standardization without erecting

barriers to competition.

  • 5.8 WHO has an important role to play, in collaboration with

interested parties, in helping to strengthen the clinical trials and

regulatory infrastructure in developing countries, in particular in

sub-Saharan Africa, including the improvement of ethical review


  • 5.9 Apart from the European & Developing Countries Clinical

Trial Partnership, donors together with medical research councils,

foundations and nongovernmental organizations, need to offer more

help to developing countries in strengthening clinical trials and regulatory


  • 5.11 All countries should consider how best to fulfil the objectives

of the Convention on Biological Diversity. This could be, for instance,

through the establishment of appropriate national regimes for prospecting

for genetic resources and for their subsequent utilization

and commercialization; contractual agreements; the disclosure of

information in the patent application of the geographical source

of genetic resources from which the invention is derived and other


2. Comparison of Incompletely Represented CIPIH Recommendations to the Indicated Corresponding Text in “Elements of a global strategy and plan of action” (A/PHI/IGWG/1/4)

CIPIH recommendation

Corresponding text in A/PHI/IGWG/1/4

3.6 Recognizing the need for an international mechanism to increase global coordination and funding of medical R&D, the sponsors of the medical R&D treaty proposal should undertake further work to develop these ideas so that governments and policy-makers may make an informed decision.

3. “Strengthen product regulatory capacity in developing countries, including improvement of ethical-review standards and clinical trials capacity.”


5. “Establish a funding mechanism for research and development for neglected diseases.”

4.16 Companies should adopt patent and enforcement policies that facilitate greater access to medicines needed in developing countries.

In low income developing countries, they should avoid filing patents, or enforcing them in ways that might inhibit access. Companies are also encouraged to grant voluntary licences in developing countries, where this will facilitate greater access to medicines, and to accompany this with technology transfer activities.

4. “Frame policies emphasizing affordable innovations adapted to realities of health-care delivery in developing countries.”

5.10 Digital libraries of traditional medical knowledge should be incorporated into the minimum search documentation lists of patent offices to ensure that the data contained within them will be considered during the processing of patent applications. Holders of the traditional knowledge should play a crucial role in deciding whether such knowledge is included in any databases and should also benefit from any commercial exploitation of the information.

2. “Promote discovery science in order to identify, validate and build up a sustainable portfolio of new products, whose development is facilitated through the screening of compound libraries for diseases relevant to the public health needs of developing countries.”

6.2 WHO should continue to monitor, from a public health perspective, the impact of intellectual property rights, and other factors, on the evelopment of new products as well as access to medicines and other health-care products in developing countries.

6. “Measure performance and progress towards objectives and targets of the global plan.”


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