The Length of Time for Prescription - Research Paper Example

A generic drug is bioequivalent or identical to a branded drug in safety, administration route, strength, dosage form, performance characteristics, quality, and use. “Products are considered to be bioequivalent if their rates and extent of absorption do not show a significant difference” (King and Kanvos, 2002, p. 463). When the protection patent term of the originator product expires, submissions may be filed by other manufacturers to the regulatory authorities to get the marketing of the originator medicine’s generic versions approved.
The current climate on this issue
The choice between generic or branded drugs also depends upon the price levels for pharmaceuticals. Industrialized countries usually have a high price of pharmaceuticals, so generic pharmaceuticals are used most frequently. Sales of generic drugs in Canada, the US, the UK, and Denmark is more than 40% of the total pharmaceutical sales (King and Kanvos, 2002). Patients are more likely to choose generic drugs as long as they get reimbursed for newer patented drugs whereas their savings are spent in making choices among the generic drugs. However, generic drugs have been heavily criticized for their substandard manufacturing and poor quality. Apart from the fact that they are not rigorously tested, the problem also relates to poor compliance of the manufacturers of generics with the practice guidelines.
The pros and cons (as well as future, unintended consequences) of shortening patents compared to other strategies
The cost of generic drugs is typically lesser than branded drugs by 30% to 60% (Lewek and Kardas, 2010). Patients on generic drugs have an increased tendency to continue therapy compared to patients who take branded drugs. Generic drugs are spared the expensive clinical trials that are a prerequisite for branded drugs to be approved which makes the quality and safety of generic drugs questionable.
Applicable cases and litigation
Some legal loopholes which delayed the approval of generic drugs have been closed by The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (FDA, 2011). This is evident from the fact that the act does not allow for more than a 30-month stay of generic approval when a generic company is sued by an innovator company with respect to patent issues. A stay is delayed in the approval of the generic drug which happens when a patent infringement lawsuit is filed by a branded drug company. The purpose of this delay is to allow time to solve issues regarding the infringement of a drug patent by a generic company. The generic drug is not approved by the FDA during the stay. 30-month stays is the limit established in line with the Federal Trade Commission (FTC) recommendations (FDA, 2011). A study conducted by FTC in 2002 revealed that in some cases from 1994 to 2000, access to the generic drugs was delayed as a result of the approval of repeated 30-month stays (FDA, 2011). In certain cases, the delay in access to generic drugs has been up to 44 months as a result of the attempt of the branded drug companies to secure repeated stays of 30-months (FDA, 2011).
Misconceptions about generic and brand
One misconception about generic drugs is that they are significantly cheaper compared to branded drugs. However, direct price controls commonly occur in generic markets. Many countries including France assert that generics’ prices should be made 30% lower than branded drugs (King and Kanvos, 2002).
Conclusion
The length of time for prescription drug patents should be reduced to encourage the entry of generic drugs because generic drugs provide the patients with a lot of benefits in terms of availability and affordability. Read More