This article turns the spotlight on national policies needed to counterbalance the ominous prospects for health bound up with international trade agreements
by Daniele Dionisio*
Policies for Equitable Access to Health (PEAH)
Domestic Policies for Trade to Uphold the Right to Health
At a time when governments in the most affluent countries are turning their agendas into monopolistic interest-friendly policies, international trade agreements such as TTIP, TPP, CETA and TISA, among others, are incurring criticism for the effects these agreements will have on access to health services for the public health.
These cases represent just the tip of the iceberg of the tactics employed to ensure that developing countries adopt measures which go beyond the full extensions they had a right to under the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS).
These measures, collectively termed TRIPS-plus, would include making it easier to patent new forms of old medicines that offer no added therapeutic benefit for patients (the so-called ‘ever-greening’); restricting ‘pre-grant opposition’, which allows a patent to be challenged before it is being granted; enforcing intellectual property (IP) beyond what TRIPS requires; allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including ‘in transit’ products that are legal in origin and destination countries; expanding data exclusivity beyond WTO’s request for data protection against unfair commercial use only; extending patent lengths beyond 20-year TRIPS requirements; and preventing drug regulatory authorities from approving new drugs if they might infringe existing patents.
TRIPS-plus measures add to the impending threat of investor state dispute settlement (ISDS) provisions with regards to access to medicines. Indeed, most currently-being negotiated or finalized trade agreements are feared to introduce ISDS clauses whereby many forms of government regulations, including price cuts of medicines that do not conflict with the TRIPS agreement, could be sued by the patent owners for alleged discriminatory practices.
ISDS risk sectors encompass tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidize home manufacturing of the same medicine. A complaint against this country under an ISDS system would be allowed to re-establish the conditions of competition in the original transaction. Additionally, the sectors relevant to packaging and labelling requirements, and to IP protection enforcement measures, may also result as ISDS target areas, since they might affect the patent holders’ access to the market of medicines. Under these circumstances, a claim could easily be lodged against a government for nullifying or eroding benefits by applying IP protection rules or packaging and labelling models that, despite full alignment with TRIPS requirements, are deemed to be insufficiently stringent or fraudulent.
Against the backdrop mentioned above, which policies should be pursued at a national level to curb the negative public health impact of international trade and investments agreements? A timely answer entails referring to the recommendations laid down on the 14th of September by the United Nations High Level Panel on Access to Medicines in their final report. The Panel was established in November 2015 and tasked with reviewing and weighing proposals and making recommendations for ending the misalignment among the right to health, and trade rules and the patent system, as the main barrier to the equitable access to health priorities.
The Panel’s recommendations take place under the UN 2030 Agenda perspective consisting of 17 Sustainable Development Goals (SDGs) and 169 targets. In this scheme, the health goal ranks high as an overarching aim amidst the other 16 SDGs. It includes nine targets: three related to the Millennium Development Goals (MDGs), three to non-communicable diseases and injuries, and three cross-cutting or focusing on systems encompassing universal health coverage, universal access to sexual and reproductive health care services, and also to reduced hazards from air, water and soil pollution. Furthermore, the health goal strictly entwines with a number of the other 16 goals. For example, health is a contributor to (and a beneficiary from) poverty reduction, hunger relief and improved nutrition, safer cities, lower inequality, sustainable consumption, affordable and clean energy, toxic chemicals management, clean water and sanitation, and to the efforts to combat climate change and safeguard aquatic and terrestrial ecosystems as well.
Overall, at a time when the SDGs focus on universal access to medicines and services for different health targets, trade agreements are undermining access to these very medicines. Now, what can be done about it, particularly at the level of national or state governance?
- Rejecting pressures towards adopting heightened IP rights and strengthened enforcement mechanisms as the keys to foreign investments and innovation. Reportedly, inclusive evidence typically shows that most low- and middle-income countries do not benefit economically from IP maximization since they are net importers of IP goods and since the path to technological development is ordinarily through copying and incremental innovation-development tools that are severely undermined by IP monopoly rights and their related restrictive licensing agreements.
- Rejecting the World Bank income classification to measure a country’s capacity to afford high-priced medicines. As argued, the World Bank classification dates back to the 1980s and only measures a country’s per-capita average of total income. However, the map of poverty has changed since the 1980s. Today, the majority of the world’s poor no longer live in poor countries, but rather in places where there is greater wealth along with higher inequality.
- Banning TRIPS-plus clauses, including ISDS provisions, since they jeopardize the right to health and make inequalities in access to care and treatments even worse.
- Pushing for open knowledge and new approaches to pharmaceutical innovation that do not rely on the patent system and de-link the costs of R&D from the end price of medicines.
- Promoting technology transfer with least-developed countries without exporting excessive IP standards through assistance programs.
- Backing generic competition as the most effective way to lower medicine prices in a sustainable way. This would include asking for organizations with potential conflicts of interests and IP perspectives to issue statements eschewing the use of IP law to counter generic medicines.
- Linking together patent offices and legislators to develop evidence-based reforms of the patent regime of medicines.As contended, If countries set higher standards for incremental innovation patenting, and permit citizen or third-party review of patents before and after examination, then we will likely see increased generic competition in the….market, new combination therapies, and lower… prices. In the longer term, higher inventiveness standards will help clear the patent thicket to allow new products to develop, and push industry towards genuine innovations.
- Ensuring that governments and leading institutions boost transparency and needs-driven rather than market-driven rules. This would mean giving up closed doors negotiations, while working with health ministries and multi-sector counterparts for decisions affecting national health, growth, employment and budgets.
- Pushing for country-governments’ leadership to implement a coordinated response to fight corruption, while refraining from being caught with corporate holdings in a circle of mutually reinforcing political and commercial interests over public health concerns.
- Asking for anti-counterfeit laws and law enforcement policies not to substitute for effective national regulatory provisions.
- Ensuring that international agreements include clauses whereby donors must strengthen WHO-aligned quality clauses in tender transactions with non-governmental organizations, while purchasers must insist that manufacturers and distributors supply medicines that meet WHO requirements, and governments must authorize export only of products meeting WHO quality, efficacy and safety standards.
As argued, Achieving health equity is not just a matter of coming up with technical solutions and providing the means to finance them. We have to consider the political landscape and rectify the dysfunctions in global governance that undermine health
*article originally published in IHP – International Health Policies
Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Dionisio is Head of the research project PEAH – Policies for Equitable Access to Health.