The pharmaceutical industry began in the 19th century, upon the discovery of highly active medicinal

The pharmaceutical industry began in the 19th century, upon the discovery of highly active medicinal compounds that could be manufactured on a large scale. (Encyclopedia Britannica Online Database). This coincided with the industrial revolution and these compounds replaced the earlier herbal medicines. The onset of the modern pharmaceutical industry also paved the way in the reduction of diseases such as typhoid fever, syphilis and tuberculoses. In fact, due to technological advancement the pharmaceutical industry helped develop newer drugs that now help in combating diseases such as cancer.

Indeed, the pharmaceutical industry has come a long way since the Industrial Revolution and continues to pave the way for new innovations in modern drugs. Yet what are the significant factors that would change the present shape of the pharmaceutical industry? This researcher has chosen to focus on five possible trends that have been investigated through the available literature on the pharmaceutical industry. There are three trends that are interconnected, with one aspect affecting the next trend and vice versa.

The following are the different trends selected by the researcher based on the existing books, journals and articles that the researcher has come across with: Trend 1: Increased Legislation on Clinical Trials and Drug Development In recent years, the media has affected legislation of pharmaceutical companies and this is can be seen more in the European Union. In 1991, the EU developed a new directive 2001/20/EC of the European Parliament in relation to clinical practices of clinical trials on medicinal products for human use. (Official Journal of the European Communities 2)

Clinical trials are important in the field of pharmaceuticals in order to determine the effectiveness of new drugs developed. In the case of the EU, the unity of the region has also challenged the way clinical trials is conducted as it differed greatly from member countries. With this new law in place, it defined the roles and definition of clinical trials. For instance, Directive 2001/20/EC initially defined the importance of “informed consent” of the people who are undertaking the clinical trails which was elaborated in Article 3 of the said article.

Furthermore, this document also stipulated laws on clinical trials conducted on minors and in Section I of Article 4, it states there that “the interests of the patient always prevails over those of science and society. ” This researcher started with the concept of legislation and clinical trials because the production of new drugs is essentially geared towards clinical trials. However, it has yet to be determined if this policy is being implemented well in the member countries of the EU, or if this policy has a bearing on legislation of other laws in other countries in the world.

Either way, it is predicted by this researcher that this policy could foreshadow more laws in order to protect people from taking clinical trials. Currently, the laws that protect individuals from being abused by the pharmaceutical industry is more favorable in the United States, United Kingdom and the European Union. Yet even as new laws are created to make existing clinical trials tighter in their responsibilities, it would seem that there are also more individuals that are taking the opportunities given by such clinical trials that would help preserve or extend their lives as well.

Trend 2: Increased Doctors Participation in the Pharmaceutical Industry According to Ginsberg, members of the Pharmaceutical Research and Manufacturers Association (PhRMA is the lobbying organization for the pharmaceutical industry) spent an estimated $2 billion on R&D in 1980. By 1995, they poured $14. 4 billion into R&D. In addition, the biotechnology industry matured. In 1995, biotech companies spent an estimated $8. 5 billion on R&D. Together, PhRMA members and biotech companies spend about $23 billion in 1995.

This represent a 10-fold increase in R&D spending in 15 years. (Ginsberg 25-29) This increase in annual expenditures for developing newer drugs also indicates that more people are involved in the research and development of newer drugs. It coincides then with the increase in medical doctors participating in the pharmaceutical industry because essentially it is the medical professionals who have an inkling towards what particular new drugs are needed based on the needs assessment of the society.

Furthermore, the increase in the budget spent could also indicate that in the next fifty years, more money would be poured towards development of newer drugs to address modern diseases that could possibly be biologically created or manufactured for potential use in biological warfare. This cannot be easily dismissed, considering the history of the use of anthrax as a biological weapon sent through the postal service system; it is now an increasing concern of the pharmaceutical industry to address this aspect and prepare for the worst possible scenario.

Furthermore, more clinical research is conducted primarily by physicians affiliated with academic medical centers. This increases the chances of physicians to become involved and the pharmaceutical companies greatly prefer to work with physician who could lend the prestige of an academic affiliation to their studies. Almost 80% of all industry grants were awarded to academic physicians. (Ginsberg 25-29) Trend 3: Greater public accountability of pharmaceutical companies Yet because of this increasing budget, certain individuals recently published books that have attacked the pharmaceutical industry, showing the public another perspective.

In Goozner’s book, The $800 Million Pill: The Truth Behind the Cost of New Drugs, Goozner began to explore the expenditures of existing pharmaceutical companies and argued that these companies in general have a greater social responsibility to its shareholders and stockholders than they have to the general public. (Goozner 4. 77 and 213). This is also echoed by Angell, in her book The Truth About the Drug Companies: How they deceive us and what to do about it. In her book, it is stated there that the pharmaceutical industry has the greatest number of lobbyists in Washington, with about 675 lobbyists in 2002, at a cost of $91 million dollars. New England Journal of Medicine 1580-1581).

These reports will create greater public accountability of the pharmaceutical companies, as the public is given more information towards the cost of producing newer drugs, and the actual cost of medicine. Even as more money is being spent towards lobbying laws in favor of pharmaceutical companies; it will only spur more public accountability as the media continues to flood the public with regular information on newer drugs, new laws stipulating clinical trails and newer methods in increasing public awareness as well.

Public accountability also indicates that there would be more information about drugs and even medication to the general populace. This is also related to the previous trends mentioned with the increase in legislation in clinical trials. Already, in the United Kingdom legislation keeps on changing as mentioned in the British Medical Journal (BMJ 241-242). Furthermore, the advent of faster information dissemination tools such as the internet guarantees that there are easier methods in creating public awareness.

For instance, it is highly plausible that lobbyists and even pessimistic researchers of the pharmaceutical industry to create their weblog that would feature aspects of their researches. Yet going back to the United Kingdom’s policy, it is clear from the article of BMJ that the nation’s policy is towards protecting human beings from being marginalized into commodities. Alas, it also shows that the continuing change in the policies would greatly effect how the pharmaceutical companies would respond to their accountability to the public.

Either way, this researcher believes that pharmaceutical companies would have greater public accountability as they continue to be attacked by the media and in relation to their funding and stockholders. This will benefit the research and development industry as well, as certain aspects of drug development lies heavily upon how society perceives the role of pharmaceutical companies. A case in point is the widely debated concept of stem cell technology, which has yet to be explored by the pharmaceutical industry because of the many ethical considerations that are being discussed with it.

Conclusion There are many trends to watch, yet as the economies of the world become increasingly globalized, so too will the concept of legislation and institutional linkages. Already the researcher has seen this with the European Union. In the near future, it could be surmised that other regions of the world such as Asia would consolidate their own body to come up with a similar governing firm towards shepherding the pharmaceutical industry in their region.

Whatever the case may be, clinical trials will be governed by such legislations, and in the process more research and money will be poured and this would lead to the continued influx of medical professionals who would market their research proposals among pharmaceutical companies in search for funding and in the end – creating more social responsibility and inevitably increasing public accountability in the pharmaceutical industry.