User:ChiaO/sandbox

Article Critique on "Prescription drug prices in the United States"

In general, the article is relevant to the article topic. However the writer, often mentions Canada and their prescription drug prices and healthcare model. The writer wording can indicate some bias. Statements such as “Prescription drug prices in the United States have been among the highest in the world,” sound more of an opinion. The statement is not followed by a citation. The page is flagged by Wikipedia for not adequately summarize its key points in the leading section. A section, “FDA backlog in generic drug application review,” was flagged for not being neutral. The leading section is relatively short and not detailed.  The authors sections vary greatly in length. Sections such as “Drug Rebates” are only three short sentences, while other sections are relatively longer. Some links lead to error pages or the article is no longer available. There is a random link to an image in the text. A few sources are not from necessarily scholarly sources, but opinion articles. Some of the writer’s statements can be backed my a citation. Her sources are all published within the last 6 years. Most conversations in the Talk page of the article call for the writer to expand on its posts and include other points of view. Various comments believe the article is more of an opinion article, and not necessarily neutral. The article is part of WikiProject Pharmacology. It is rated as Start-Class on the project’s quality scale and Low-Importance on the project’s importance scale. We discussed a class how a Wikipedia article post should be neutral and unbiased but this article does a poor job at that.

Potential Articles

1. TRIPS Agreement
   1. TRIPS Agreement
   2. can add a section about the DOHA DECLARATION
2. Doha Declaration
   1. Doha Declaration
   2. connection to global access to medicine
   3. add more content to 'Reception'
3. Access to medicines
   1. Access to medicines
   2. Section about legislation
      1. TRIPS
      2. DOHA
      3. POTENTIAL SOLUTIONS

Outline of Wiki Article - Access to medicines

1. Factors That Block Access
   1. Data Exclusivity
   2. Doha Declaration
      1. J C Cohen-Kohler. (2007). The Morally Uncomfortable Global Drug Gap. Clinical Pharmacology & Therapeutics, 82(5), 610-4.
         1. Legislation such as Doha Declaration of 2001, that works to rectify the negative impact of the TRIPS Agreement. This negative impact led to the Doha Declaration of 2001, which allows for the use of compulsory licensing for pharmaceutical drugs only in the case of a national emergency--such as to address public health issues. The declaration also allows for countries without manufacturing capabilities to turn to a third country, such as Canada for the export of medicines. It also highlights the right of respective government to interpret the TRIPS Agreement in terms of public health.
   3. Trips Agreement
      1. Wiernikowski, J., & MacLeod, S. (2014). Regulatory and logistical issues influencing access to antineoplastic and supportive care medications for children with cancer in developing countries. Pediatric Blood & Cancer,61(8), 1513-1517.
         1. It argued that the Trade Related Intellectual Property Rights (TRIPS) agreement, which strengthened intellectual property laws, procedures,and remedies, however negatively impacted generic drug industries in countries such as India.
2. Potential Solutions

"Access to Medicines" Draft

Patent Protection & Market Exclusivity

Patents provide a owner exclusive rights to a product or process for 20 years in a particular territory. The owner of the patent has the right to prevent manufacturing of the patented product. Patent protection allows pharmaceutical companies a monopoly on particular drugs and processes.

Data Exclusivity

Data exclusivity is a regulatory measure limiting the use of clinical trial data and provides conductor of the trial temporary exclusive rights to the data (Diependaele, L., Cockbain, J., & Sterckx, S. (2017)). Many suggest that extending exclusivity periods can have consequences in delivering medication, especially generic brands, to developing countries. However, extending patent terms can be reinvested for research and development and/or a source of funding for drug donations to low-income countries (Steven, Huys). Others suggest that data exclusivity works to diminish the availability of generic drugs. Many argue that pharmaceutical companies push for data exclusivity--seeking to extend their monopolies by advocating for market exclusivity provided by patents and data exclusivity, or protection for new medicine.

Cost

Due to factors such as market exclusivity and data exclusivity, a pharmaceutical company ultimately have control of the pricing of their patented product. Therefore, the owner also has control of the pricing of the medication, based on the price level the owner deems best to reflects their ability to manufacture and the level of profit desired. Purchasers have little say over the price set.

Daraprim price hike

On August 10, 2015, Turig Pharmaceuticals, a pharmaceutical company owned by Martin Shkreli, purchased the rights to a Daraprim. Daraprim, an anti-parastic and anti-malarial drug, is considered a essential drug for HIV treatments. It is widely used to treat patients with AIDS-related and AIDs-unrelated toxoplasmosis. At the time, no other generic versions of the drug was available. Turig dramatically raised the price of the drug from $13.50 a tablet to $750, a 5000% increase.

Trips Agreement

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), is a multilateral agreement between all member nations of the World Trade Organization (WTO), effective January 1995. This agreement introduced global standards for enforcing and protecting nearly all forms of intellectual property rights (IPR), including those for patents and data protection. Under the TRIPS Agreement, WTO member nations, with a few exceptions, are required to adjust their laws to the minimum standards of IPR protection. Member nations are also obligated to follow specific enforcement guidelines, remedies, and dispute resolution procedures. Before TRIPS, other international conventions and laws did not specify minimum standards for intellectual property laws in the international trading system. The TRIPS Agreement is argued to have the greatest effect on the pharmaceutical industry and access to medicines. It is argued that the TRIPS agreement negatively impacted generic drug industries in countries such as India. However, others argue that the agreement is open to interpretation. A clause in the TRIPS agreement allows compulsory licensing, which permits the manufacture of generic brands of patented drugs, at prices set in a competitive market in cases of national emergencies.

HIV/AIDS Crisis

For example, many believe that the HIV/AIDs crisis in Africa and South East Asia and the inadequate access to essential AIDs medications constitute a national emergency. Therefore, the TRIPS Agreement can be interpreted to allow the manufacture of generic brands of patented HIV/AIDs drugs.

Doha Declaration

Further legislation such as Doha Declaration of 2001 worked to rectify the negative impact of the TRIPS Agreement. The Doha Declaration on the TRIPS Agreement and Public Health, effective November 2001, was adopted by WTO Ministerial Conference of 2001. Many argued that the TRIPS Agreement hindered developing countries from implementing measures to improve access to affordable medicines, especially for diseases of public health concern, such as HIV, tuberculosis, and malaria. The Doha Declaration responds to concerns of developing countries that patent protection rules and other IPRs were hindering access to affordable medicines for populations in those countries. The Doha Declaration emphasizes the flexibility of the TRIPS Agreement and highlights the right of respective government to interpret the TRIPS Agreement in terms of public health. It refers to specific parts of TRIPS, such as the use of compulsory licensing for pharmaceutical drugs only in the case of a national emergency and circumstances of extreme urgency and the right to determine what constitutes this --such as to address public health issues. The declaration also allows for countries without manufacturing capabilities to turn to a third country, such as Canada for the export of generic brands of patented medicines.

Global Challenges to Medication Access

Africa

There is estimated to be more than 4 million HIV infected individuals in South Africa. Out of this, only 10,000 individuals are able to afford access to vital essential AIDS medications at their current prices. In Malawi, out of one million infected individuals, only 30 have access to life-sustaining essential AIDS medications. In Uganda, out of the estimated 820,000 infected individuals, only about 1.2% can afford essential AIDS medications.

Latin America

There is estimated to be 1.8 million individuals HIV infected individuals in the Latin American region. Brazil is argued to be one of the most affected by the AIDS epidemic. There is also a high prevalence of HIV in smaller countries such as Guatemala, Honduras, and Belize. However, Brazil is argued not to have restrictive patent laws. In the mid 1990s, Brazil began manufacturing generic brands of vital AIDS medication. Brazil's AIDS mortality rate declined by almost 50%.

Vaccines

The majority of deaths from vaccine-preventable diseases occur in low and middle income countries. In low-income countries, more than 90% of deaths are from pneumococcal disease, 95% from Hib, and 80% from hepatitis B. Although widely used by high-income countries, in 2006, Hib vaccine usage in Africa was about 24% In the Americas, Hepatitis B vaccine usage was at 90%. In Southeast Asia, where there is hepatitis B epidemic, the Hib vaccine coverage was only 28%.