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INTRODUCTION
When Gordon Earl Moore, a co-founder of Intel®, spoke of technological development and costs in 1965, he postulated that computer processing power would double every 18 months, without a corresponding increase in their cost. This hypothesis proved to be accurate, and became known as Moore's Law. In contrast, technological innovations in medicine have resulted in increasing worldwide health care costs which, unlike what would be expected if Moore's Law also applied to medicine, have not significantly decreased with technological development. In fact, only 0.5% of effective innovations cost less than the technology they were developed to replace.1,2
Today, 17.9% of the gross domestic product of the United States of America (USA) goes toward health care, as compared to only 4% in 1950; the health sector has gained increasing importance in the economy, and 25 years from now it may absorb up to 30% of United States' GDP.1–3 In the USA, approximately US$ 12 billion is spent every year on endovascular devices. Ninety percent of aortic aneurysms in the USA are treated using endovascular surgery. It is estimated that US$3.96 billion, in Brazil, and US$260 billion worldwide is spent on endovascular devices every year. Meditronik® and Gore® in the USA, Cook® in Australia and Braile Biomédica® in Brazil4–6 are the largest of the 17 major manufacturers of endovascular products in the world.
Technological advances in the form of new medications, more sophisticated diagnostic procedures (which allow for the early discovery of previously underdiagnosed conditions), and more effective surgical materials and techniques are the main reasons for worldwide increases in health care spending.7–11
Therefore, in recent years, innovations and patents in medicine have had increasing social and economic repercussions, as has development of endovascular devices such as catheters, stents, grafts and wound dressings. Although the duration of surgery and recovery times associated with endovascular procedures have decreased, the cost of endovascular devices has sharply increased, which is primarily due to the fact that such products are usually imported. This situation creates a distortion of sorts, in that medical knowledge and experience appear to have become less relevant than technological innovation, surgical devices and civil responsibility.1–11
In light of these observations, the objective of this study was to conduct a retrospective analysis of patent and regulatory approval data for newly developed vascular and endovascular devices, based on the number of patents registered at the Brazilian National Industrial Property Institute (INPI) and of products approved by the National Health Surveillance Agency (ANVISA) over recent years.
METHOD
This was a retrospective study conducted on data recorded between January 1997 and December 2012. Data on technological developments for endovascular surgery were retrieved through electronic searches on the INPI website (www.inpi.gov.br), and information on the approval of new technology was acquired from the ANVISA website (www.anvisa.gov.br). The following keywords were used for the electronic search: "stent(s)," "graft(s)," "catheter(s)" and "wound dressing(s)." Any patent entries identified by these keywords, but which did not describe a vascular/endovascular device were discarded from the sample. The term "guide wire" was excluded from the search because it resulted in an insignificant number of patents and product approvals.
The search results were used to analyze changes in the number of patent registries and product approvals over the course of the period studied. The percentage of newly patented products that were also approved for use by ANVISA was also analyzed.
RESULTS
The electronic search revealed that 701 new patents for vascular and endovascular devices were registered with the INPI during the period studied (Table 1). Thirty-four percent (n=237) of these were patents for wound dressings, 16% were for stents, 5% for grafts and 45% for catheters. Most of the patents found were registered between 2005 and 2011 (Figure 1).
Table 1 Number of patents registered with the INPI between 1997 and 2012.
| Search terms | N |
|---|---|
| Stent(s) | 113 |
| Graft (s) | 36 |
| Catheter(s) | 315 |
| Wound dressing(s) | 237 |
| Total | 701 |
The search also revealed that ANVISA approved the use of a total of 3433 new endovascular products over the period studied (Table 2). Approximately 11.9% of these (n=410) were new types of wound dressings, 6% were stents, 1% were grafts, and 81% were catheters. The number of products approved by ANVISA remained stable over the course of the period studied (Figure 2).
Table 2 Number of products approved by ANVISA between 1997 and 2007.
| Search terms | Total | Brazil* |
|---|---|---|
| Stent(s) | 184 | 8 |
| Graft(s) | 46 | 12 |
| Catheter(s) | 2793 | 135 |
| Wound dressings) | 410 | 113 |
| Total | 3433 | 268 |
*Products manufactured in Brazil.
Only 7.8% (n=268) of the 3433 products approved by ANVISA during the period analyzed were produced in Brazil (Table 2). When the results retrieved using each search term were analyzed separately, 4.3% (n=8) of the entries were found to refer to stents, 26.08% (n=12) to grafts, 4.8% (n=135) to catheters and 27.5% (n=113) to wound dressings.
DISCUSSION
Although only a small number of firms are involved in the production and development of endovascular devices, this is a billion-dollar market, and the public health demand for new technology in the area have grown steadily over recent years. Although modern technology is often expensive, it may be financially worthwhile in the long term if it is able to reduce the recovery times and morbidity rates associated with endovascular procedures.1–4
The results show that a large number of patents were registered with INPI, suggesting that there have been significant technological advances in the area of endovascular surgery.7–11 However, the low number of products approved by ANVISA suggests that this technology has not been successfully applied to clinical practice. Over the course of the period studied, only 8 of the 113 stents for which INPI granted patents were approved for use by ANVISA.
Continued reliance on foreign technology may be responsible for the increased cost of technological advances in health care. Current debates regarding copyright law and the fact that patent registries are closely monitored in all developed countries have created a need for local alternatives to imported vascular and endovascular devices. The operative knowledge of physicians may play an important role in this process, which could eventually open up a promising new field for both health care and the economy.11
Given the potential economic and social repercussions of this type of technology, it becomes crucial to monitor developments in innovation and patent registries, and to make significant financial investments in the development of these materials. This would offer both a direct benefit for endovascular surgery patients and an indirect benefit to society, due to the increase in jobs and income associated with the establishment of new manufacturing industries. The need for local investment in such technology is particularly clear if we consider the costs associated with continuing reliance on imported material. In the USA, which does not rely so heavily on imported health care products, health spending is already expected to increase over the next 25 years, and it is predicted that it will eventually absorb 1/3 of the country's GDP. If a similar pattern occurs in Brazil, and the additional cost of imported healthcare products is added to these estimates, the economic consequences could be extremely negative.4–12
There is an urgent need for the medical community to play a more active role in public policy in this area, investing in innovation and emphasizing the importance of managing and monitoring patent registries, with the objective of developing local alternatives to imported diagnostic and treatment procedures for angiology and vascular surgery, thereby contributing to patent output, which has become a new measure of wealth in the modern world.
