Globalization Of Clinical Trials And The Pharmaceutical World Essay

There are some trials that are being worked on around the world right now. For example, in 2013 a trial of an experimental treatment for advanced malignant melanoma took place in London at the Royal Marsden Hospital. One of the patients received three intravenous infusions, and after the second one the lumps that had been in her throat and breast had vanished. While those results were extraordinary, it is by far not the only time to have happened. There have been many similar trials that had the same results as this one. These new anticancer drugs are being called cancer inhibitors and some scientists are saying it could be the “turning point in cancer treatment.” Instead of

In recent years, it has become an increasingly popular practice for drug companies to perform their clinical testing of new drugs in foreign countries that might not have the consumer protections or product liability laws present in the United States. Please answer each of the following questions using a theory studied in Module 2 specifically and thoroughly and using examples and facts from the readings and resources.

Economic: Globalization of the pharmaceutical industry is an exciting opportunity to have research and development done at cheaper prices in other countries. However, this could be a double edged sword for companies because it is easy for other countries, such as India, to produce generic versions of the drug in bulk.

Expanding into Asia (including India) so as to implement lower cost clinical testing and share opinions with leaders in the medical industry appeared to be a viable option. Drug prices however were substantially lower in India, profits were capped at 6% and post manufacturing costs were limited at 100%.

1. Pricing: Many Asian and African countries are poor and cannot afford the costly medicines. The Pharmaceutical firms spend vast amounts on R&D in creating and marketing drugs, thus charging high prices enables for cost of capital recovery and profit generation.

U.S. based companies hold rights to most of the world’s rights on new medicines and holds thousands of new products currently being developed. As of 2012, the industry helps support almost 3.4 million jobs in the U.S. economy. It is also one of the most heavily R&D based industries in the world. In the United States, the environment for pharmaceuticals is much friendlier than other countries around the world in terms of pricing ability and regulations. Both the Pharmaceutical and Biotechnology industries have experienced significant growth in the past year with year-over-year increases of 13.02% and 34.69% respectively. It is an even more striking when looking at the past five years considering both have beat out the S&P 500 with pharmaceuticals increasing an additional 31.44% and the biotechnology sector besting an astonishing 269.3% more return than the

However, according to economic data released by the Association of Pharmaceutical Research (Interfarma) in Brazil they invested just over $ 139 million in research, while in the world they invested $ 40 billion. Brazil 's participation in clinical trials worldwide is 1.2%, and the time taken for approval of a clinical trial in Brazil is between 10 and 14 months. Between 2005 and 2009 the international patent

While the steps to bring a new drug to market may seem extensive and costly, they are a necessity. Clinical drug trials provide options for people with diseases while also allowing doctors to improve the way they diagnose and treat these diseases. The process is long, but the benefits that new drugs have to offer, is

Drug companies that test experimental drugs in foreign countries are acting unethically. They are acting unethically, such that they are not disclosing results from the tests. As per the national Pharmaceutical Control Bureau’s Web site, there are specific guidelines with which the experimenters would have to adhere to when dealing with drug reactions (Health-Asia, 2007, February 2). Following a practice like this is imperative because patient safety is number one. Additionally, recording results and sharing them is common decency for families that are affiliated with the person being tested. If something bad happened, such as death, families, if present and involved, should be notified. Another reason as to why I feel recording results is important is the fact that it allows for the experimenters/doctors to have visual data of what drugs work and what drugs do not work. This would enable them to potentially improve on any faults that are present in the drugs and prevent future casualties.

Critical issued of the appropriateness of conducting clinical trials in emerging countries has arisen over years. Being a leading company in biopharmaceutical industry, Novo Nordisk faces the critiques of whether it is justice to offshoring their clinical trials in developing economies. With the consistency of ethical principles brought up by Novo Nordisk, the company would be able to move their trials into emerging economies with the best interest for stakeholders. I will also propose ideas to Mr, Dejgaard for possible approach to media as well as the practices that Novo Nordisk could have changed over time at the end.

The cost of new medical drugs seems to be accepted by many people who use them. These pharmaceutical companies increase their profits more and more each year because many people assume that it does cost a lot of money for research and development. Where in reality, they are only spending about 15% of their profit margins on research and development alone. A huge percentage of these drugs are actually tested in other countries where people are more willing to do trials with these drugs because they cannot afford them. Not only are there more people who are more willing to try them, but also there is less regulation and oversight when it comes to testing. Conducting these clinical trials overseas not only saves

Drug prices are set by pharmaceutical companies to cover research and development costs. While R&D costs clearly need to be covered, markets in developed countries already pay for most R&D of new products. Because of this, it makes moral and economical sense to establish a two-tiered pricing system; for R&D costs to be paid for by developed countries, allowing significantly reduced prices to be charged in developing countries.

Further more, with other benefits such as low costs in research and development, strong clinical research capabilities, and low sovereign risk, Australia is advancing as one of the most prominent players in the pharmaceutical industry (Productivity Commission 2003). Australia’s population represents 0.3% of the world’s population and consumes around 1% of the total global pharmaceutical sales. The industry generated a total revenue of $6.1 billion in the year 2002 (ALRC 2014).

This report provides an analytical strategic review of the global pharmaceutical industry; its origin, evolution,

There are a number of challenges in for setting up clinical trials and performing biopharmaceutical development. In fact, China has the longest drug application timeline of all Asian countries. Language , culture, infrastructure, regulatory and quality issues are some other challenges in the emerging economies