In-depth knowledge about a subject may generate a number of questions. It then becomes necessary to ask whether these questions can be answered through one study or if more than one study needed.1 Additional research questions can be developed, but several basic principles should be taken into consideration.1 All questions, primary and secondary, should be developed at the beginning and planning stages of a study. Any additional questions should never compromise the primary question because it is the primary research question that forms the basis of the hypothesis and study objectives. It must be kept in mind that within the scope of one study, the presence of a number of research questions will affect and potentially increase the complexity of both the study design and subsequent statistical analyses, not to mention the actual feasibility of answering every question.1 A sensible strategy is to establish a single primary research question around which to focus the study plan.3 In a study, the primary research question should be clearly stated at the end of the introduction of the grant proposal, and it usually specifies the population to be studied, the intervention to be implemented and other circumstantial factors.4
Articles in this theme include multi-country studies that span between nine and 76 countries. Four econometric retrospective studies examined the impact of patent policies on various aspects of drug launches [81,82,83,84]. A study of 68 countries assessed how regulatory polices affect whether new drugs are launched in a country and how quickly [82]. Similarly, three studies investigated how patent regimes affect the timing of drug launches in 76 countries [81], the speed of drug launch, price and quantity of drugs sold [84] and how the introduction of product patents affect the likelihood that pharmaceutical firms launch new and innovative medicines [83]. This study also measures how much patent owners or generic firms modify their prices to local income levels in 70 countries [83]. Findings suggest that longer patent protection facilitates market entry of new drugs in high income countries, though the evidence is mixed as to whether longer patent periods improve access to new medicines in LMICs [82]. Similarly, Watal and Dai found that pharmaceutical product patents facilitated the likelihood of drug launch, though in low-income markets this effect is limited. Innovative medicines are launched sooner than non-innovative ones and differential pricing does not appear to be adjusted to local income levels [83]. These findings were reinforced by Cockburn et al. who found that longer and more extensive patent provisions facilitate launches of new drugs; however, in contrast to the other studies the findings were equally applicable to low- and middle-income countries as high-income countries [81]. Similarly, Kyle and Qian found patents to be associated with earlier launch of new products, higher drug prices and higher sales volumes. However, they also found that the increase in price associated with patents was smaller in lower income countries and suggested that policies to countervail price increases were therefore effective [84].
marketing an introduction 5th canadian edition pdf 53
This theme included two studies from Canada and one from Australia. A prospective modelling study from Canada measured the cost to the Federal government of patent term extensions caused by the introduction of SPCs, a requirement of CETA [101]. This is estimated to lead to higher provincial and national drug expenditure [101]. Another study from Canada costed the impact of the introduction of the patent term extension legislative changes of 1987 and 1993 to the Canadian Patent Act and found that there was negligible impact on provincial drug prices before 1995; however patent term extension could be responsible for the very large increases incurred since then [102].Footnote 19
The introduction of the US Hatch-Waxman Act in 1984 was designed, inter alia, to promote early and efficient access to generic drugs. This was to be done by facilitating accelerated approval by the Food and Drug Administration (FDA), the national regulator, to allow for market entry of generics as soon as patents expired, or were otherwise found to be invalid or not infringed [14]. Studies which focused on generic market entry in the USA found that the introduction of the Hatch-Waxman Act resulted in a rise in patent challenges [63], an increase in the number of patents associated with each medicine [105] a rise in the generic share of the market [64], consumer welfare gains [62] and a decrease in daily treatment costs [64]. To maximise profits, however, many originator brands patent reformulations to lessen the financial impact of patent expiry [68]. Among best-selling drugs, Feldman found that over 70% of medicines listed in the Orange Book added additional patents or data exclusivity privileges to the medicine, indicating extensive use of secondary patenting [105].
With very few exceptions, the articles in this review found that the introduction of patents following implementation of TRIPS rules and pharmaceutical-related TRIPS-plus IP provisions are associated with an increase in drug prices, consumer welfare losses and increased costs to consumers of pharmaceuticals and national governments. Studies in this field can be complex and the quality of the findings is dependent on when impacts are measured, the context and choice of methods.
(b) Encourage the development of different forms of secondary education, including general and vocational education, make them available and accessible to every child, and take appropriate measures such as the introduction of free education and offering financial assistance in case of need;
The purpose of this section is to establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely-debilitating illnesses, especially where no satisfactory alternative therapy exists. As stated 314.105(c) of this chapter, while the statutory standards of safety and effectiveness apply to all drugs, the many kinds of drugs that are subject to them, and the wide range of uses for those drugs, demand flexibility in applying the standards. The Food and Drug Administration (FDA) has determined that it is appropriate to exercise the broadest flexibility in applying the statutory standards, while preserving appropriate guarantees for safety and effectiveness. These procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely-debilitating illnesses, than they would accept from products that treat less serious illnesses. These procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated. The procedure outlined in this section should be interpreted consistent with that purpose.
If the preliminary analysis of phase 2 test results appears promising, FDA may ask the sponsor to submit a treatment protocol to be reviewed under the procedures and criteria listed in 312.305 and 312.320. Such a treatment protocol, if requested and granted, would normally remain in effect while the complete data necessary for a marketing application are being assembled by the sponsor and reviewed by FDA (unless grounds exist for clinical hold of ongoing protocols, as provided in 312.42(b)(3)(ii)).
Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.
All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing and the safety of products following marketing approval apply to drugs covered by this section. This includes the requirements for informed consent (part 50 of this chapter) and institutional review boards (part 56 of this chapter). These safeguards further include the review of animal studies prior to initial human testing ( 312.23), and the monitoring of adverse drug experiences through the requirements of IND safety reports ( 312.32), safety update reports during agency review of a marketing application ( 314.50 of this chapter), and postmarketing adverse reaction reporting ( 314.80 of this chapter). 2ff7e9595c
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