Posts Tagged: "WHO"

A bipartisan group of 28 members of congress, including Senate IP Subcommittee Chair Chris Coons (D-DE), Ranking Member Thom Tillis (R-NC) and House IP Subcommittee Chair Darrell Issa (R-CA), sent a letter yesterday to President Biden urging the administration to reconsider its December proposal to allow agencies to consider pricing in deciding whether and when to “march in” on patent rights. Also yesterday, four bipartisan senators wrote to National Security Advisor Jake Sullivan in opposition to the negotiating text of the World Health Organization (WHO) Pandemic Agreement, warning that it “would undercut—if not destroy—the very aspects of our innovation ecosystem that just recently produced such positive results.”

On December 22, the U.S. Department of Health and Human Services (HHS) issued a notice and request for comments (RFC) regarding the United States’ negotiating position on a draft convention on pandemic preparedness being developed at the World Health Organization (WHO). The HHS’ RFC specifically targets certain portions of the draft convention that would impact intellectual property (IP) ownership, research & development, and technology transfer for pandemic-related technologies.

The process of bringing a new pharmaceutical drug to market is time-consuming and expensive. The process of naming the new drug, while not as scientifically complex, is often no less work. Drugs have several names, including their chemical (or scientific), generic (or non-proprietary) and brand (or proprietary) names. The chemical name specifies the molecular structure of the drug. The generic name specifies the underlying compound of the drug and includes a “stem” that informs health care professionals about how the drug will work in the body. In the United States, generic names must be approved by the United States Adopted Names (USAN) Council and the World Health Organization (WHO) INN Programme. While the chemical and generic names may be available for use by others in the industry, the brand name—under which the new drug is typically marketed—is unique and exclusive to the brand owner and is the focus of this article.

The United States National Institutes of Health (NIH) signed a deal today with the World Health Organization’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) that allows manufacturers greater access to key COVID-19 technologies owned by NIH. The licensing agreement offers 11 technologies under transparent, global and non-exclusive licenses. They include “the stabilized spike protein used in currently available COVID-19 vaccines, research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics.”

The horrific second wave of COVID-19 in India has compelled the government to introduce an expedited vaccination drive from May 1, 2021, where all citizens above the age of 18 (and not just priority groups) will be eligible to register. The program also came with the promise of an introduction to several new vaccines in the market. A majority of the states also decided to roll out the vaccine for free. Unfortunately, reports that stock had run out followed shortly in several states. States like Maharashtra and Delhi had to keep the drive on hold. Bengaluru also faced supply problems ahead of the drive. A popular proposition is that patent restrictions and exclusivity of “know-how” are a barrier to adequate production of vaccines.

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.

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.

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.

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.

We understand governments have a responsibility to protect the health of their citizens and therefore, should regulate harmful products. However, there is no compelling evidence that restricting the use of brands will improve public health… The standardized packaging of tobacco products also sets a dangerous precedent for other goods and services, including alcoholic beverages, soft drinks, snack foods, fast foods and even baby formula, a number of which are already being targeted with severe packaging restrictions, including tobacco style plain packaging.

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss healthcare developer Roche (VTX:ROG) received FDA approval this March for a new quantitative RNA test which can help physicians see exactly what level of HCV exists in a patient’s blood instead of simply confirming an active infection. Earlier this year, in late January, the FDA granted approval to Merck & Co. (NYSE:MRK) for a once-daily single tablet treatment branded as Zepatier. Zepatier is another combination drug therapy which incorporates elbasvir and grazoprevir, both HCV RNA inhibitors, and is designed to treat patients having one of two strains of HCV, including the most common strain. A 12-week regimen of the treatment costs $54,600.