Posts Tagged: "World Health Organization"

When it comes to how to best increase access to medicines in l0w and middle-income countries (LMICs), compulsory licensing gets most of the attention. Academic articles, non-governmental organization (NGO) campaigns, conferences and United Nations (UN)-endorsed technical symposia assert it is the best approach. Certain World Trade Organization (WTO) members are pushing for COVID-19 treatments and diagnostics to be included in the waiver of intellectual property rights under the Agreement on Trade-Related Aspects of IP Rights (TRIPs waiver), which revolves around compulsory licensing. Brazil has recently amended its IP laws to make compulsory licensing easier. Despite its high political profile, compulsory licensing has rarely been used (mainly by a handful African countries in the mid 2000s to address the HIV pandemic). Even then, IP-respecting treatments available from global procurement bodies have proven cheaper. No country has yet seen the need for a compulsory license for a COVID vaccine.

A terrible idea – wayward and ill-conceived, criticized by all economic, political and geopolitical fronts – has come to fruition. The World Trade Organization’s (WTO) TRIPs waiver on patents related to COVID-19 vaccines will disincentivize the entire industry from investing in vaccine production. To understand what happens next, let’s understand history first.

One-hundred-twenty-four professors and academics from around the world have penned an open letter supporting India and South Africa’s proposed waiver of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which they claim will help to combat the COVID-19 pandemic. According to a press release about the letter, the United Kingdom, Ireland, Australia, Brazil, Japan, Norway, Switzerland and the EU continue to oppose the waiver proposal. The United States expressed its support for waiver in May. Over the last several weeks, Europe has doubled down on its opposition to the proposal in ongoing talks.

President Biden recently announced his support for easing patent rules surrounding COVID-19 vaccines and other COVID-related intellectual property in the wake of growing crises in India and South Africa. Despite President Biden’s public support, easing the international patent rules requires a unanimous decision on the part of the World Trade Organization (WTO), which is still uncertain. However, with the United States’ announcement, the European Union (EU) will also reportedly consider the issue. Predictably, major pharmaceutical companies, including the three pharmaceutical manufacturers with vaccines approved for use in the United States — Pfizer, Moderna, and Johnson & Johnson —have lobbied against easing patent rules. But, given the uniquely global reach of the pandemic and the practical barriers to the production and distribution of vaccines on a global scale, it would be a mistake not to provide patent infringement waivers. What is the need? What is the legal issue? And will it make a difference?

On Friday, May 29, the World Health Organization (WHO) officially launched the COVID-19 Technology Access Pool (C-TAP), an initiative which is intended to improve access to treatments, vaccines and other medical technologies which are developed in response to the global COVID-19 pandemic. The program, initially proposed by Costa Rica, has highlighted the tension between pharmaceutical developers and advocates for access to medicine, which has been magnified by the economic concerns created during the global shutdown.

Since China announced the first fatality caused by a virus about which little was known at the time, coronavirus and the disease it causes, COVID-19, has grown to pandemic proportions. In the less than three months since that first death, this new strain of the severe acute respiratory syndrome-related (SARS) coronavirus has shuttered social gatherings, precipitated a mandatory work-from-home revolution and decimated large parts of the world’s economy. As of the afternoon of March 27, the Coronavirus Resource Center at Johns Hopkins University reports that more than 585,000 cases of COVID-19 infection have been confirmed worldwide, resulting in a total of 26,819 deaths. Those figures have been increasing exponentially each day.

The cost of medicines is on the agenda this week at the World Health Organization’s annual executive board meeting in Geneva. Nongovernmental organizations and certain middle-income countries argue that market-based drug development—reliant on intellectual property rights (IPRs) as its primary incentive—makes medicines too expensive. It fails, they say, to provide cures for those most in need but least able to pay. On the fringes of meetings such as the one happening this week, nongovernmental organizations talk excitedly about a new model for drug development, in which research and development (R&D) costs are “delinked” from the final prices of drugs. They join notables such as U.S. Senator Bernie Sanders and Nobel prize-winning economist Joseph Stiglitz. One of the main “delinkage” proposals is to replace the patent system with government-managed prizes.

Protecting innovation through patents is the lifeblood of the global pharmaceutical industry. Without patents the world and its expanding population would be deprived of new and, ultimately, affordable life-saving medicines. Nevertheless, the high profitability of pharma companies has prompted an increasingly widespread (and often ill-informed) political debate on patents. This is not just because of mounting health costs but also the lack of access to life-saving medicines in developing countries. But this argument on the alleged high costs caused by patents falls short because most patents for essential medicines on the World Health Organization (WHO) list are expired and are available at generic medicine prices. Even so, patients in countries where they are most needed do not have access to generics. And the reasons for this are multiple, not least inadequate, poorly-funded healthcare systems.

The dangers of killer germs and superbugs are not limited to bird flu in China, Ebola in West Africa, Zika in South America and MERS in the Middle East… If we are to have a fighting chance against superbugs and pandemics, we must invest in innovation and safeguard the property rights that incentivize these discoveries. Short-sighted efforts to enervate existing intellectual property rights laws and policies will not only damage incentives to innovate, they may hand a victory to the superbugs.

The WHO is gathering governments, academics and activists in Amsterdam next month to discuss price setting options for medicines. But the so-called Fair Pricing Forum ignores the main driver of higher healthcare spending and will do more harm than good. While there is a pressing need to balance access to affordable medicines and the incentives to innovate, a reactionary focus on prices is misdirected and could have dire consequences for pharmaceutical innovation… The WHO’s exclusive focus on price setting also misses the mark on another issue – medicines are working to extend lives and even to lower overall healthcare spending by eliminating the need for more expensive interventions, such as surgery and hospitalization.

Because the production costs of these medical devices and pharmaceuticals are so high, millions of people around the world are unable to obtain necessary healthcare. For example, as of 2014, close to seventy percent of all cardiac pacemaker sales occurred in the United States and Europe, while several countries in Africa and Asia have absolutely no access to pacemakers. In order to respond to this problem, research scientists have begun developing low-cost medical technologies and using intellectual property rights to give people in developing countries access to adequate healthcare.

Legislating for tobacco-style plain packages for confectionery is a disproportionate response to the obesity crisis and strips companies of valuable trademarks, writes the Institute of Economic Affairs’ head of lifestyle economics.

‘Plain packaging’ is a policy which eliminates all branding and visual design elements on products and forces manufacturers to use state-mandated colors and typefaces to create homogenized packaging with no differentiating features. Plain packaging is currently only applied to tobacco products in a handful of countries worldwide, but if health activists have their way that will change.

Delayed for months beyond its expected issue date the Secretary General’s High Level Panel on Access to Medicine’s report emerged yesterday. Apparently the panelists scrambled to better disguise their predetermined agenda behind reams of soothing rhetoric. While lip service is given to the unimagined advances in medicine under the current industry led drug development system, that’s quickly discarded under the pretext of providing better access to health care for the world’s poorest citizens through a system run by international bureaucracy. These recommendations are largely directed at the US life science industry. Luckily, one panel member provides an effective rebuttal to this approach but unless his message is repeated many public officials, media outlets and the general public could come to accept that a government run system would be “more fair.”

The vast majority of medicines found on WHO’s model list of essential medicines are off-patent according to information published by the World International Property Organization (WIPO). As of 2013, 95 percent of the 375 pharmaceutical compounds on that year’s MLEM were off-patent, indicating a high likelihood that generic equivalents of treatments are available. Going back to the early 2000s, the percentage of essential medicine on WHO’s MLEM which are off-patent has consistently been between 90 to 95 percent. Thus, it seems clear that the patent system has served its intended purpose: To incentivize the creation of important, innovative, even live saving products that society can reap the benefits from long after the exclusivity of the patent has expired.