International agreements, laws and regulations

The regulation and resolution of disputes can be resolved through UN agencies and by international courts.
With regard to global health, key international WTO agreements cover the following areas:

the protection of intellectual property (Agreement on Trade-Related Aspects of Intellectual Property Rights – TRIPS Agreement)
trade in services (General Agreement on Trade in Services – GATS
the reduction of barriers to trade (Technical Barriers to Trade Agreement – TBT)
measures to protect trade health (Sanitary and Phytosanitary Measures – SPS)

International treaties and laws include the Framework Convention on Tobacco Control (FCTC), the International Health Regulations and orphan drug laws.

Tobacco regulation is one example of where the European Commission has played an influential role, on a global scale and in many regards, beyond the activities of the member states and the traditional interpretation of the EU’s legal competencies in public health. In the last 20 years, the EU has undertaken an extensive range of measures that has had an enormous influence, both within and outside the EU.

The EU also gave the European Commission dispensation to negotiate, at WHO, the International Health Regulations of 2005. In the event, the European Commission played a central role in these negotiations. The regulations require the 193 WHO member states to monitor and control threats to international health, including infectious diseases and potential bioterrorism. It did not specify what should be monitored and controlled but left it to states to identify and monitor key threats. Within the EU, the European Centre for Disease Control, along with partners in EU member states, will play a central role in coordinating international public health measures. Other states may also require support and advice to help define threats to international health and to strengthen their health protection services.

Orphan drug laws were copied from the US – where they originally applied to rare diseases – and applied by the EU to drugs for low-income countries where drug development would not otherwise be financially viable.

These developments demonstrate the advantages of regionally coordinated action on international agreements, laws and regulations for health and the growing role of the EU and EC in this arena.

More on International Agreements, Laws and Regulations

Further Definitions

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS):

The TRIPS Agreement affects public health to the extent that it may limit access to affordable medicines in some countries. The areas of intellectual property covered by the TRIPS Agreement relevant to health include: patents, trademarks, copyrights, and undisclosed information, including trade secrets and test data. In respect of each of these areas, the Agreement defines the minimum standards of protection that must be adopted by each member. Yet, while it introduced a multilateral framework for intellectual property rights, and obliges World Trade Organization (WTO) members to adhere to minimum standards of intellectual property protection and enforcement, it does not prescribe a universal or harmonised intellectual property regime.

In each area of intellectual property rights, it should allow governments to provide for exceptions, exclusions and limitations to these rights, for example in relation to patent rights whereby the TRIPS Agreement permits compulsory licensing, parallel imports and other exceptions to exclusive patent rights. In this manner, the provisions in the TRIPS Agreement may be used to strike an appropriate balance between creating incentives for innovations, and the need for access to technology and information, for example to counter threats to health.

Although it was generally acknowledged that the TRIPS Agreement contained sufficient flexibility to permit implementation consistent with public health, developing countries faced difficulties in their attempts to implement safeguards such as parallel imports and compulsory licensing in their domestic legislation. The legal challenge by the pharmaceutical industry of a provision that enabled parallel imports in South Africa’s Medicines and Related Substances Amendment Act (Act No. 90 of 1997) and the US initiated complaint against Brazil in the WTO dispute settlement system over a provision in the Brazilian domestic legislation on compulsory licensing, were two of the better-known cases that prompted developing countries to demand a clarification in the WTO.

The interpretation and scope of the flexibilities in the Agreement and the use of these flexibilities to improve access to essential medicines were the main source of debate, which culminated in the adoption of the Doha Declaration on the TRIPS Agreement and Public Health. This declaration clarified that countries were within their rights to make use of measures, such as compulsory licensing and parallel imports, for public health purposes and to ensure access to medicines. Compulsory licensing, for instance, would allow countries to enable generic production of new products, and thus create the necessary pressures for price competition. Equally important, WTO Members, in singling out pharmaceutical products for special treatment, have also recognised that health products need to be treated differently in certain circumstances. The Doha Declaration thus represents an agreement between WTO Members that public health considerations should condition the extent to which patent protection is implemented.

However, the Doha Declaration had left one issue unresolved. In Paragraph 6, the Doha Declaration had recognised that developing countries without manufacturing capacity would face difficulties in making effective use of compulsory licensing. Since the TRIPS provision restricts exports of products manufactured under compulsory licence, countries without manufacturing capacity dependent on foreign generic producers would have a problem sourcing adequate supplies of generic medicines produced under compulsory licence. To resolve this problem, the WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on TRIPS and Public Health established a system to permit the production and export of generic versions of patented medicines by waiving the restriction on exports under compulsory licence. The system permits countries wishing to import generic medicines, to do so from a foreign producer under certain conditions of eligibility and notification of the TRIPS Council. Members recently agreed to convert the WTO Decision on Paragraph 6 into an amendment of the TRIPS Agreement.

The TRIPS Agreement, the Doha Declaration and the WTO Decision on Paragraph 6 now collectively comprise the international framework governing the rights of countries to take measures to protect public health. Since intellectual property rights are territorial and governed by domestic laws, it will be necessary for specific provisions, where none exists, to be effectively enacted in domestic law to enable their use within each country. For this reason, it is important for countries to implement the TRIPS flexibilities appropriately within their domestic legislation.

The General Agreement on Trade in Services (GATS):

The GATS may be applied to the international trade in health services, including health insurance and health care provision. The definition of trade in services in the Agreement hinges on four types of transactions or “modes of supply”, namely: the cross-border supply of services (e.g., telemedicine, e-Health), consumption of services abroad (patients who travel abroad for medical treatment), commercial presence (establishment of health facilities in the country concerned), and presence of natural persons (foreign doctors or nurses who seek to practice in other countries). Informed and evidence-based approaches are needed to manage any future efforts to liberalise health-related services so as to ensure greater access to affordable, better-quality, and effective services, leading to increased choice for consumers and greater equity in health outcomes.

In the past, most services were not considered to be tradable across borders. Much has occurred to alter the tradability of services, including health services. Advances in communications technology, including the development of e-commerce, as well as regulatory changes in many parts of the world have made it easier to deliver services across borders. In many countries, changes in government policy have left greater room for the private sector-domestic as well as foreign-to provide services. Partly as a result, services have become the fastest-growing segment of the world economy, providing more than 60 % of global output and employment.

Such changes led governments to include services in trade negotiations, resulting in the GATS at the end of the Uruguay Round. GATS takes a gradual approach to trade liberalisation allowing member states to include or exclude services such as health insurance and care. So far, the liberalising effects have remained limited as most WTO Members have made relatively few commitments that go beyond existing levels of access. However, many fear that opening up health markets in developing countries could lead to foreign companies “cherry picking” the most profitable sectors, to the disadvantage of local health services.

It goes unnoticed that GATS also provides for the control of the international movement of staff for the provision of services. As the 2006 World Health Report on human resources for health points out, the migration of health workers to rich countries is a fundamental cause of poor health and health care in resource-poor countries. Yet at present this provision has not yet been applied to the recruitment of health staff from developing countries to rich regions such as Western Europe. Instead, a weaker form of control is applied through conventions and bilateral agreements that have been very ineffective in stemming the flow of health professional migration.

Technical Barriers to Trade Agreement (TBT):

The TBT Agreement on technical barriers to trade can also be relevant to health. WTO rules which govern technical barriers to trade applied for reasons of protecting human health are covered by either the TBT Agreement or the SPS Agreement. Countries face challenges in ensuring compliance with the disciplines of SPS and TBT. This is particularly the case in the areas of food safety, diagnostic devices and medicines’ quality, safety and efficacy, respectively, in which the trade agreement creates obligations to draw up regulations based on science, conduct required risk assessments, and implement international standards through independent and effective national regulatory authorities.

All members have the right to restrict trade for “legitimate objectives” under the TBT Agreement. These legitimate objectives include the protection of human health or safety, the protection of animal or plant life or health, the protection of the environment, national security interests, and the prevention of deceptive practices. The TBT Agreement aims to ensure that product requirements, and procedures that are used to assess compliance with those requirements, do not create unnecessary obstacles to trade. The Agreement applies to product requirements that are mandatory (“technical regulations”) as well as voluntary (“standards”). It covers such requirements developed by governments or private entities, whether at the national or the regional level.

The TBT Agreement strongly encourages the use of international standards, such as WHO standards, and where appropriate for these to be adopted as national standards or technical regulations. Members may depart from such international standards if they consider that their application would be ineffective or inappropriate for the fulfilment of certain legitimate objectives. In such cases, Members are free to set standards at a level they consider appropriate, but have to be able to justify their decisions if requested by another Member to do so.

Sanitary and Phytosanitary Measures (SPS):

The SPS Agreement contains specific rules for countries which want to restrict trade to ensure food safety and the protection of human life from plant or animal-carried diseases (zoonoses). Its objective is two-fold: it aims to (i) recognise the sovereign right of Members to determine the level of health protection they deem appropriate; and (ii) ensure that a sanitary or phytosanitary requirement does not represent an unnecessary, arbitrary, scientifically unjustifiable, or disguised restriction on international trade. In order to achieve its objective, the SPS Agreement encourages WTO Members to use international standards, guidelines and recommendations where they exist. Members may adopt SPS measures which result in higher levels of health protection-or measures aimed at health concerns for which international standards do not exist-provided that they are scientifically justified.

The SPS Agreement encourages the use of international standards. In the area of food safety, the SPS Agreement explicitly recognises the international standards developed by the joint FAO/WHO Codex Alimentarius Commission. This means that if a government has based its requirement, such as a maximum residue level for a pesticide in a food, on a Codex standard, it is presumed to be meeting its WTO obligations.

In the context of sanitary issues such as mad cow disease or avian influenza, the use of SPS has had an increasing impact on EU exports in recent years, prompting the Commission to create a database of SPS exports that provides information on export problems with third countries. EU countries themselves have resorted to using the SPS mechanism. It is expected that this use will increase as other trade barriers are reduced in the future.

Framework Convention on Tobacco Control (FCTC) and the European Community:

Between 1998 and 2003 the WHO proposed and negotiated the United Nation’s first ever health treaty and invited its 192 Member States to develop a Framework Convention on Tobacco Control (FCTC). The FCTC covered all aspects of tobacco control and “presented a complex negotiating scenario for the European Community and its Member States because some areas were subject to exclusive EC competence, some were shared between the Member States and others were exclusively the preserve of the Member States” (European Communities, 2004, p.126).

Article 13 of the FCTC requires that each party “in accordance with the constitution or constitutional principles, undertake a comprehensive ban on all forms of advertising, promotion and sponsorship.” This ban would occur within 5 years of the Convention entering into force. The final discussions on Article 13 occurred during the last round of FCTC negotiations in February 2003, just 2 months after the EC directive on tobacco advertising was agreed to by the EC in December 2002. The agreement in the EC’s health council facilitated the EC’s endorsement of the advertising provisions of the FCTC despite the objections of Germany who strongly opposed Article 13. Germany maintained that the EC directive on tobacco advertising should be annulled and took the European Parliament to the ECJ. Nonetheless, most of the 25 EU members did ratify the FCTC. This resulted in an obligation to ban tobacco advertising within 5 years for all countries, except for those able to prove constitutional impediments to doing so. In the end Germany’s request for judicial review was denied when the Solicitor General upheld the legality of the EC’s internal directive on advertising. Thus internal EU legislation served to strengthen the WHO Framework Convention, essentially establishing legal precedent and paving the way for Member State policy makers to accept the regulations of the international treaty as standard.

Another example of the EC’s impact on the FCTC can be seen in the negotiations regarding the Convention’s article 11. One of the strongest provisions in the FCTC, Article 11 recommends that health warnings should be 50% or more of the principal display areas on tobacco products, but requires that they be no less than 30%. The issue of warning labels threatened to be a topic that would make or break the Convention. According to the Analysis of the Science and Policy for European Control of Tobacco (ASPECT) Report, “without the endorsement of the EC for these labelling requirements, Article 11 of the FCTC would have been much weaker” (European Communities, 2004, p.126). The report claims that negotiations for this legally binding convention were not concluded until approximately 3 AM on the 1st of March 2003, and that there was strong opposition from the USA, Japan, and even Australia, to include a requirement that health warnings should occupy 30% of the principal display areas. During the first week of the last round of the negotiations in February 2003 attempts were made to weaken the provision by including the sentence “parties will endeavour to require that such warnings be…” However, because of the EC commitment, the final agreement maintained the initial strong obligations.

Furthermore, Article 11 (1) of the FCTC also states:

“Each Party shall, within a period of 3 years after entry into force of this Convention for that Party, adopt and implement, in accordance with its national law, effective measures to ensure that:

(a) tobacco product packaging and labelling do not promote a tobacco product by any means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions[…] These may include terms such as ‘low tar’, ‘light’, ‘ultra-light’, or ‘mild’.”

As of early 2003, only the European Community and Brazil had introduced legislation banning the use of misleading descriptors. The inclusion of this important provision in the Convention would not have been possible without the pre-existing EU law in this area. (European Communities, 2004, p.126)

In the absence of an extensive legal competence public health, the EU’s legal competence to regulate the internal market has been used. The tobacco industry and member states such as Germany have tried to claim that this has been an abuse of power by the Community and has made extensive use of the judicial review provisions in the Treaty to attack these directives. The European Court of Justice (ECJ) and the Solicitor General have largely rejected these claims and upheld the EC directives. The complex interactions resulting in the EC tobacco-control legislation have “had both a positive and negative effect on tobacco control in Member States, countries waiting to join the EU, and organisations like the WHO and its Framework Convention” (European Communities, 2004, p.134).

The EC has traditionally lacked room to manoeuvre on the international stage, as foreign policy (outside of trade) is generally the sole competence of the Member States. However, the WHO created an opening for the EC in 1999 with its Resolution WHA52.18, which “provides a mechanism for regional economic integration organizations constituted by sovereign states, for instance the European Community, to participate actively in the work of the intergovernmental negotiating body and working group established [for the Framework Convention for Tobacco Control]” (Puska, Bettcher, and Yach, 2000, p.5). This opportunity has been fully utilized and “as the European delegate to the 52nd World Health Assembly noted, ‘On the matters covered by Community legislation and policies, member states had transferred their competency, including negotiation of treaties, to the European Community’” (Puska, Bettcher, and Yach, 2000, p.5).

International Health Regulations 2005 (IHR):

The International Health Regulations (IHR) is an international legal instrument that is binding on 194 countries across the globe, including all the Member States of WHO. Their aim is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide.

In the globalized world, diseases can spread far and wide via international travel and trade. A health crisis in one country can impact livelihoods and economies in many parts of the world. Such crises can result from emerging infections like Severe Acute Respiratory Syndrome (SARS), or a new human influenza pandemic. The IHR can also apply to other public health emergencies such as chemical spills, leaks and dumping, or nuclear melt-downs. The IHR aim to limit interference with international traffic and trade while ensuring public health through the prevention of disease spread.

The IHR, which entered into force on 15 June 2007, require countries to report certain disease outbreaks and public health events to WHO. Building on the unique experience of WHO in global disease surveillance, alert and response, the IHR define the rights and obligations of countries to report public health events, and establish a number of procedures that WHO must follow in its work to uphold global public health security.

The IHR also require countries to strengthen their existing capacities for public health surveillance and response. WHO is working closely with countries and partners to provide technical guidance and support to mobilize the resources needed to implement the new rules in an effective and timely manner. Timely and open reporting of public health events will help make the world more secure.

International and Regional Orphan Drug Laws:

The so-called “orphan drugs” are drugs for which there is a very small or economically limited market, due to either the low proportion of the population which demands the drug, or a low proportion of the population with the ability to pay for the drug. For these reason private firms have traditionally not invested in Research and Development (R&D) for orphan drugs. When this concept first gained popularity in the US in the early 1980s “orphan” status referred to diseases (in the US) with less than 200,000 patients. In recent times however, this status has been expanded to include diseases such as HIV which affect millions worldwide but for which there was a very weak market given average incomes around the world. Under The U.S. Orphan Drug Act of 1983 firms that develop drugs for rare or “orphan” diseases became eligible for a 50% tax credit on their clinical development expenses. This “push” type policy is further combined with other incentives including development grants, counselling and guidance from the Food and Drug Administration (FDA), and a guaranteed seven year market exclusivity period (“pull” type incentives). While these policies primarily focus on the neglected diseases on the industrial world, there has been an increasing focus on the neglected diseases of the developing world, and similar “pull” tools, such as the advanced market commitments are being piloted at the international level.

Following its success in the US, similar Orphan Drug legislation has also been enacted in Japan (1993) and the European Union (1999). In 2008 the European Medicines Agency (EMEA) and the US FDA began using the same application procedures to allow for simultaneous application for orphan drug status in the US and EU markets. The orphan drug acts demonstrate how policy tool proved effective at the national level can translate into effective cooperation for global health.