The TRIPs Agreement and Pharmaceuticals
(2000; 91 pages) View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentLIST OF ABBREVIATIONS AND ACRONYMS
View the documentEXECUTIVE SUMMARY
View the documentI. INTRODUCTION
Open this folder and view contentsII. GENERAL ISSUES
Open this folder and view contentsIII. TECHNICAL ISSUES
Open this folder and view contentsIV. SPECIAL ISSUES
View the documentV. ISSUES DISCUSSED IN WORKING GROUPS
View the documentVI. RECOMMENDATIONS
Close this folderANNEXES
View the documentANNEX A - Workshop Agenda
View the documentANNEX B - Opening Remarks
View the documentANNEX C - Selected Articles of the TRIPS Agreement
View the documentANNEX D - List of Participants
 

ANNEX B - Opening Remarks

Opening Address by Dr. Achmad Sujudi,
Minister of Health, Republic of Indonesia

Distinguished Experts or Facilitators from WHO/HQ, WTO, WIPO, Consumers International and other International Experts
Distinguished WHO Representative to Indonesia and ASEAN Secretariat
Distinguished Delegates of ASEAN member countries,
Distinguished guests, ladies and gentlemen

It is my pleasure to welcome you all today to this ASEAN workshop on the TRIPS Agreement and its impact on pharmaceuticals. I believe that all participants from all ASEAN countries involving various sectors namely health, trade, commerce, industry, legislation and consumers will share information and raise the awareness on these challenges posed by international trade on human health.

I extend sincere thanks to the World Health Organization and the Rockefeller Foundation, for collaborating with us in financially supporting and organizing this workshop. I would also like to thank the delegates from ASEAN member countries, UN Agencies, international NGOs and other institutions for joining and facilitating the workshop.

Ladies and gentlemen,

Globalization and trade liberalization is an inevitable condition that will enter every country in this world. The liberalization of trade in health is not extremely recognized by the people in the health sector, although many people have discussed the matter, not much action has been taken. To prepare for globalization one country cannot work alone but has to work together with other countries. For this reason, the 5th ASEAN Health Ministerial Meeting which was held last week in Yogyakarta has agreed upon the importance of strengthening the collaboration among ASEAN countries with regards to the health implication of trade liberalization and international trade agreement. I, therefore convince this ASEAN workshop will be very useful on such matter for all parties concerned, at both inter and intra ASEAN countries.

The TRIPS agreement requires patent protection to be available for any invention in any field of technology in all WTO member countries. This becomes very important, particularly it is also aimed at pharmaceuticals, which in many countries it had previously - totally or partly - been excluded from patent protection. Due to the TRIPS Agreement, however, pharmaceuticals are now subject to the globally harmonized system in all member countries.

Distinguished guests, ladies and gentlemen,

Although social benefits may arise from patent protection through the discovery of new drugs, the TRIPS standards may be a challenge to many developing and least developed countries. Studies on the TRIPS agreement indicate that the globally harmonized high standards of TRIPS patent system may have great impact on the health sector and may affect negatively in the access of drugs in the developing and the least developed countries.

The availability and accessibility of drugs at the basic health service level is an essential component of the national health policy in many countries and will remain one of the priorities in their national health policy in the future. Concerns and apprehensions on the implications of the TRIPS agreement on health sector have already been expressed at the World Health Assembly and in other international forum on health. We agree with the message from the World Health Assembly that public health interest is of paramount consideration. Although most of essential drugs have already been off-patent, the access to essential drugs, particularly for those new drugs potentially to be essential must be safe guarded in the implementation of the trade agreements. We consider that in the negotiations of multilateral trade agreements and their implementation, public health concerns must be heard and weighed appropriately.

Ladies and gentlemen,

In order to comply with the TRIPS agreement and other agreements under the WTO convention, most ASEAN countries will have to revise their national legislation related to intellectual property rights. Depending on their level of development, countries have until 2000 or 2005 to amend their legislation. In this regard, understanding on its implication on the health sector is urgently needed and the options to safeguard public health interests must be secured.

The TRIPS agreement contains complex and controversial issues. Therefore, the highest promotion of the understanding of the Agreement and of its health implications among participants is essential. Experts from around the world, who have the extensive experience on patent issues, will facilitate on the various issues of intellectual property rights, particularly related to pharmaceutical sector. The interaction among participants and experts is expected to improve the understanding on the Agreement and the capacity and knowledge to effective deal with a number of health related issues included in the Agreement. This will assist participants to identify some options to safeguard health interests in the implementation of the Agreement and in future negotiations.

Ladies and gentlemen,

Based on guiding principle, vision and mission, policies, directions and strategies of the new framework for ASEAN cooperation in health development as well as ASEAN spirit, your valuable inputs would be able to address these challenging issues and to establish an appropriate mechanism for minimizing the negative impact and maximizing the potential gains. I wish you all success in the process, output and follow-up of this workshop. I also wish you fruitful deliberations and a pleasant stay in Jakarta.

In full hopes and with the blessing of God Almighty on us all, I hereby declare the ASEAN workshop on the TRIPS agreement and its impact on pharmaceuticals officially opened.

Thank you.

Remarks from Dr. Suthad Setboonsarng,
Deputy Secretary General of the Association of South-East Asian Nations
(ASEAN)
Read by Mr Yong Chanthalangsy, ASEAN Secretariat

H.E. Dr. Achmad Sujudi, the Minster of Health of Indonesia
Dr. Georg Petersen, WHO Representative to Indonesia
Distinguished guests,
Ladies and Gentlemen,

It is indeed a great pleasure for me to address the opening of the ASEAN Workshop on TRIPS Agreement and its impact on Pharmaceuticals. Allow me to congratulate Directorate General of Drug and Food Control of Indonesia for convening this meeting at this very important juncture.

Excellencies,

Ladies and Gentlemen,

The Sixth ASEAN Summit, held in December 1998 in Ha Noi, emphasized the theme: “Unity and Cooperation for an ASEAN of Peace, Stability and Equitable Development”. The ASEAN Leaders declared among others: we shall, together, make sure that our people are assured of adequate medical care and access to essential medicines; and we shall endeavor to narrow the gap in the levels of development among the Member Countries and reduce poverty and socio-economic disparities through greater sub-regional cooperation.

The Ha Noi Plan of Action (HPA) adopted by the Sixth ASEAN Summit stated among others that ASEAN has to ensure adequate and effective protection, including legislation, administration and enforcement, of intellectual property rights in the region based on the principles of the Most Favored Nation (MFN) treatment, national treatment and transparency as set out in the TRIPS Agreement.

In recognizing that economic progress does not translate into gains for the poor, vulnerable and infirm nor can guarantee access to basis needs such as health care, the ASEAN heads of government, earlier at their Second Informal Summit held in December 1997, spelled out their vision a dynamic, economically integrated by 2020 which is also a socially cohesive and caring ASEAN where hunger, malnutrition, deprivation and poverty are no longer basic problems.

When the TRIPS Agreement is looked at from this perspective, one should not forget that the availability of, and accessibility to drugs at affordable prices for people is essential in ASEAN and will remain one of the priorities in ASEAN’s health policy in the future. Therefore, in bringing the legislation in line with TRIPS Agreement, sufficient attention must be given to ensure the health of the people because the TRIPS Agreement may also have impact on accessibility to medicines.

ASEAN member countries are in the process of implementing the activities of the Ha Noi Plan of Action (HPA) related to intellectual property rights. One of the activities of the HPA is to ensure that intellectual property legislation of ASEAN member countries conform to the TRIPS Agreement of the WTO through the review and introduction of TRIPS-consistent intellectual property laws.

As things stand now, ASEAN member countries which are WTO members have amended their existing and introduced new intellectual property legislation to comply with the TRIPS Agreement and those that are not members of the WTO, have prepared their intellectual property laws and regulations based on the WIPO model law. Thus, intellectual property laws, especially the patents law of most of the ASEAN member countries are and will be TRIPS compliant.

The availability of new technology in the health and pharmaceutical industries present both challenges and opportunities for the region. ASEAN has to quickly work together address these challenges and take advantage of the opportunity.

The rapid integration of the international market also requires ASEAN to work closer in international for a to safeguard its interests. Joint positions should be forged, where possible. This is important not only in the WTO but also in other for a where international standards or regulations are being established.

Distinguished guests,
Ladies and Gentlemen,

Another important issue is the need for assistance from developed countries and relevant international organizations in relation to the implementation of the TRIPS Agreement, and human resource development so that ASEAN can implement the TRIPS Agreement efficiently and have the necessary skills to negotiate with their counterparts.

Within ASEAN, the ASEAN Working Group on Intellectual Property Cooperation (WGIPC) was established in 1996 under the purview of the ASEAN Senior Economic Officials (SEOM) to implement the activities of the Program of Action and the HPA and to serve as a forum for regular consultations and to monitor regional and international developments in intellectual property.

One of the activities of the Working Group is to explore the possibility of setting up ASEAN common trademark and patent systems. As an initial step towards the eventual establishment of such systems, ASEAN member countries agreed to set up ASEAN Regional Trademark and Patent Filing Systems. The Experts Groups on Trademarks and Patents established by the WGIPC are currently working towards the finalization of the filing systems.

A Pharmaceutical Product Working Group (PWG) was also set up to address harmonization of pharmaceutical regulations among ASEAN Member Countries. The objective of the PWG is to develop harmonization scheme of pharmaceutical elimination of technical barriers to trade posed by the regulations, without compromising on drug quality, efficacy and safety.

In its work, the PWG has taken into account the current regulations in ASEAN Member Countries, activities of the WHO and the International Conference on Harmonization (ICH). The following areas were initially identified by the PWG for harmonization under respective Ad Hoc Committees: Pharmaceutics (Quality); Pharmacological and Toxicological Data (Safety); Clinical Data; and Administrative Data and Product Information.

Ladies and Gentlemen,

The 5th ASEAN Health Ministers’ Meeting, held from 28 to 29 April 2000 in Yogyakarta, agreed upon, among other the missions: to ensure availability and accessibility of safe, affordable, efficacious and quality health related products and services to meet the needs of ASEAN; to strengthen the national and collective ASEAN capacity on the issues of health implications from globalization and trade liberalization; and to enhance the competitiveness of ASEAN health related industries taking into account the strength and diversity among ASEAN Member Countries.

Among other actions in the adopted plan of action to address the impact of globalization/trade liberalization on the health sector, the Ministries agreed to: harmonize product registration requirements and standards for health products; develop strategies to strengthen ASEAN’s capacity and competitiveness on health related products (pharmaceuticals, including traditional medicine and biomedical products, including vaccines) and health services; develop a system to monitor the health of vulnerable groups in ASEAN countries; to strengthen collaboration on health research and development with a focus on pharmaceuticals, including traditional medicines and biomedical products, including vaccines; and intensify development of human resources for health in the area of globalization and trade liberalization.

May, I, finally, express my sincere thanks to the World Health Organization (WHO) for its technical assistance given to the ASEAN. The relationship between the WHO and ASEAN has been a very fruitful one thanks to the implementation of the Memorandum of Understanding between the two organizations.

Good health is the most virtuous fortune. It will not happen by itself. ASEAN has to work harder and closer to accomplish a Healthy ASEAN by 2020 where economic progress has a human face, as called for the ASEAN Vision 2020.

I wish this meeting all the success.

Thank you

Remarks by Dr. Georg Petersen,
WHO Representative to Indonesia

His Excellency Dr Achmad Sujudi,
His Excellency Mr Yong Chanthalangsy,
Distinguished Participants, Ladies and Gentlemen,

I am pleased to be with you here today at the start of this important workshop.

At the beginning of the 21st century, we are faced with persistent inequalities in health status, between as well as within countries. This is a problem affecting disadvantaged populations in developed and developing countries alike. It highlights a worldwide need for health policies that focus on disadvantaged populations.

As you know, availability and accessibility of drugs in health facilities is crucial to the successful implementation of the national health policies, and will remain so in future.

A country’s health service cannot respond to people’s needs unless it guarantees that people have access to essential drugs of assured quality. Access to drugs represents a very important measure of the quality of health services, and is one of the key indicators of equity and social justice.

Access to essential drugs is a key priority for the World Health Organization. Our longstanding aim is to help ensure equity of access to essential drugs of good quality, and to promote their rational use. This is simply part of the fundamental right to health care, and our work in WHO is built on this premise.

During the last two decades, much has been achieved in expanding access to drugs and vaccines; the number of people having access to essential drugs has nearly doubled, from 2 billion in 1977 to nearly 4 billion in 1997.

Yet, we still have a long way to go. Today, one-third of the world’s population still lacks access to the drugs it needs. In the poorest parts of Africa and Asia, over 50% of the population does not have access to the most vital medicines.

Many factors determine the complex question of access; these include adequate financing, reliable supply systems and affordable prices. While all these factors need to be in place, we should avoid the pitfall of simply shifting the blame, of making a shortfall in one factor the justification for the poor performance of another.

We are all aware of the formidable challenges faced by countries in the pursuit of their health development goals. Nowadays, the health sector is facing not only its own systemic problems, but also challenges imposed by the external environment. These challenges have assumed a new, complex and bigger dimension with globalization and international trade liberalization.

In the context of trade liberalization, health concerns and apprehensions have mainly focussed on the implications of the TRIPS Agreement on the pharmaceutical sector.

In a very divers world, the TRIPS Agreement sets uniform, high standards for the protection of Intellectual Property Rights, including for patenting of pharmaceuticals.

These high standards, some believe, will encourage research and the development of new medicines.

Others argue that these standards will increase prices, and thereby reduce access to drugs, especially of the poor.

Let me be clear: we need both.

New medicines are needed to combat old and re-emerging diseases, such as malaria and TB, and to deal with newer diseases such as AIDS.

But new medicines are of little help if those who need them most cannot afford them; if they widen the health gap, instead of bridging it.

We will need to find a balance between pressing public health needs, and legitimate private sector interests.

We will have to look for new solutions, and in doing so we will have to be honest and creative.

We will have to work together, as partners.

We will have to find new ways to link supply to demand and to need.

Together, we have to succeed where the market has failed.

For the market has failed.

In developing countries, an estimated 8 million children under 5 years old died last year. They died of diseases for which we have the cures - but their parents or their countries could not afford them. Eight million children per year - that means 21,900 children today.

Similarly, priority setting for research and development in the pharmaceutical market is imperfect. Research priorities may match (economic) demand, but often they do not match medical need.

We cannot stress it too much: essential drugs are not simple commodities like any other.

But medicines are traded. They are produced, marketed and sold across the globe - benefiting some, but failing to reach too many others. So the rules regulating this trade are crucial.

In our globalized world, the rules governing trade are laid down in a number of international agreements: the WTO Agreements. One of them is the TRIPS Agreement, which this workshop will examine in detail.

The TRIPS and other WTO Agreements provide for a number of safeguards, meant to protect the public interest and public health. We should make sure that these safeguards are fully understood and used properly.

We should study our options under those safeguards carefully, and make wise decisions, which protect health, while not hampering trade unnecessarily.

For the 191 member countries of the WHO have clearly stated, in the World Health Assembly, almost exactly one year ago, that, at the interface of health and trade, public health interests are paramount.

Ladies and gentlemen,

This is the 2nd time in 2 weeks that delegates from the ASEAN countries meet in Indonesia to discuss about globalization in relation to health. This, I think, is significant.

It shows - I hope - that health is becoming more important, or rather, that there is an increasing awareness of the link between health and development. We have known for years that poverty causes ill health, but nowadays it is becoming increasingly clear that ill health also keeps people in poverty.

Health is not a luxury, and health care is not a peripheral issue; health is part and parcel of the development process and of poverty eradication.

We in the health sector have known since a long time that diseases do not stop at borders. Recently, here in the ASEAN region we have learnt, much to our cost, that in our global village, financial and economic crises can behave like contagious diseases, spreading rapidly from one country to the next. This has taught us that, while globalization has the potential to bring many benefits, it also has potential dangers. And like in disease control, we will have to work together to minimize the risks and to maximize the benefits.

Therefore, if we want to integrate health and development, in order to improve both and to seriously reduce the problems of poverty, we will have to look beyond our borders.

Beyond our national borders, and beyond the borders of our - familiar - health sector. I am very pleased to see that this workshop brings together people from different countries and different sectors. People concerned about health and people concerned about justice, trade and development.

I think this can be a very powerful forum for launching ideas and identifying options that will help us to move forward in our common aim to ensure that the people in this region can obtain the medicines they need, as an important step to improve health and reduce poverty.

I am therefore looking forward to the outcome of this workshop, and I wish you success with your efforts to address this important topic.

Thank you.

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