China's growing biomedical industry

The biomedical industry in China is developing rapidly, and new biological drugs are increasing their share of the pharmaceutical market based on people's needs. China is the largest producer and user of vaccines in the world, but the existing production of vaccines is far from enough to meet the needs of the market. The entire market of biological drugs in China is still smaller than that for traditional medicines and chemicals. Therefore, the biopharmaceutical industry has the potential to be the rising star in the pharmaceutical market in the future.     

Patent and Exclusivity Status of Essential Medicines for Non-Communicable Disease

Objective

The threat of non-communicable diseases (“NCDs”) is increasingly becoming a global health crisis and are pervasive in high, middle, and low-income populations resulting in an estimated 36 million deaths per year. There is a need to assess intellectual property rights (“IPRs”) that may impede generic production and availability and affordability to essential NCD medicines.

Methods

Using the data sources listed below, the study design systematically eliminated NCD drugs that had no patent/exclusivity provisions on API, dosage, or administration route. The first step identified essential medicines that treat certain high disease burden NCDs. A second step examined the patent and exclusivity status of active ingredient, dosage and listed route of administration using exclusion criteria outlined in this study.

Materials

We examined the patent and exclusivity status of medicines listed in the World Health Organization’s (“WHO”) Model List of Essential Drugs (Medicines) (“MLEM”) and other WHO sources for drugs treating certain NCDs. i.e., cardiovascular and respiratory disease, cancers, and diabetes. We utilized the USA Food and Drug Administration Orange Book and the USA Patent and Trademark Office databases as references given the predominant number of medicines registered in the USA.

Results

Of the 359 MLEM medicines identified, 22% (79/359) address targeted NCDs. Of these 79, only eight required in-depth patent or exclusivity assessment. Upon further review, no NCD MLEM medicines had study patent or exclusivity protection for reviewed criteria.

Conclusions

We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global populations for these essential medicines.     

Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment

Background

Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil''s AIDS treatment program has been cited widely as the developing world''s largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005.

Methods and Findings

We compared Brazil''s ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil''s reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir–ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs: patented lopinavir/r, efavirenz, tenofovir, atazanavir, enfuvirtide, and a locally produced generic, fixed-dose combination of zidovudine and lamivudine (AZT/3TC). Because prices declined for many of the patented drugs that constitute the largest share of drug costs, nearly the entire increase in overall drug expenditures between 2001 and 2005 is attributable to increases in drug quantities. Had all drug quantities been held constant from 2001 until 2005 (or for those drugs entering treatment guidelines after 2001, held constant between the year of introduction and 2005), total costs would have increased by only an estimated US$7 million. We estimate that in the absence of price declines for patented drugs, Brazil would have spent a cumulative total of US$2 billion on drugs for HAART between 2001 and 2005, implying a savings of US$1.2 billion from price declines. Finally, in comparing Brazilian prices for locally produced generic ARVs to the lowest international prices meeting global pharmaceutical quality standards, we find that current prices for Brazil''s locally produced generics are generally much higher than corresponding global prices, and note that these prices have risen in Brazil while declining globally. We estimate the excess costs of Brazil''s locally produced generics totaled US$110 million from 2001 to 2005.

Conclusions

Despite Brazil''s more costly generic ARVs, the net result of ARV price changes has been a cost savings of approximately US$1 billion since 2001. HAART costs have nevertheless risen steeply as Brazil has scaled up treatment. These trends may foreshadow future AIDS treatment cost trends in other developing countries as more people start treatment, AIDS patients live longer and move from first-line to second and third-line treatment, AIDS treatment becomes more complex, generic competition emerges, and newer patented drugs become available. The specific application of the Brazilian model to other countries will depend, however, on the strength of their health systems, intellectual property regulations, epidemiological profiles, AIDS treatment guidelines, and differing capacities to produce drugs locally.     

武汉市公立医院药品价格水平实证研究

目的 了解武汉市公立医院的药品相对价格水平,揭示药品市场现存的问题。方法 选择全国市场销售排名前100位的药品全部纳入研究样本,收集武汉市12家公立医院和14家零售药房的药品价格数据,对定量资料进行统计分析,对公立医院间及其与零售药房间的药品价格进行差异性比较。结果 公立医院的药品均价高于零售药房同商品名药品的均价;公立医院间同商品名的药品均价差异不显著,但同通用名的药品价格差异有较大的波动性。结论 进一步建立健全药品监管制度,加快削弱公立医院的垄断地位,严格药品招标采购管理,建立健全国家基本药物制度。     

Access to Orphan Drugs: A Comprehensive Review of Legislations,Regulations and Policies in 35 Countries

ObjectiveTo review existing regulations and policies utilised by countries to enable patient access to orphan drugs.MethodsA review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country.ResultsFifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country’s legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country’s pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access.ConclusionsOverall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.     

Antibiotic bill doesn't GAIN enough ground

With an eye to tackling the growing problem of antimicrobial drug resistance, uS lawmakers last month proposed new incentives to jump-start the ailing antibiotic industry. but the legislation as written is not likely to have the intended consequences, as it fails to adequately shield companies from competition with generic drugs. To truly entice investment and research from the drug industry, the bill needs to simplify the path to regulatory approval, provide greater protection from generic competition and aid drug companies with intellectual property extensions, tax relief and guaranteed market commitments.     

GLOBAL HEALTH IMPACT: A BASIS FOR LABELING AND LICENSING CAMPAIGNS?

Most of the world's health problems afflict poor countries and their poorest inhabitants. There are many reasons why so many people die of poverty‐related causes. One reason is that the poor cannot access many of the existing drugs and technologies they need. Another, is that little of the research and development (R&D) done on new drugs and technologies benefits the poor. There are several proposals on the table that might incentivize pharmaceutical companies to extend access to essential drugs and technologies to the global poor. 1 Still, the problem remains – the poor are suffering and dying from lack of access to essential medicines. So, it is worth considering a new alternative. This paper suggests rating pharmaceutical and biotechnology companies based on how some of their policies impact poor people's health. It argues that it might be possible to leverage a rating system to encourage companies to extend access to essential drugs and technologies to the poor.     

Regulating pharmaceutical advertising: What will work?

As Dr. Joel Lexchin makes painfully obvious in this issue (see pages 351 to 356), regulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be regarded by manufacturers as the cost of doing business, and any regulatory body that includes drug industry representatives or individuals receiving financial support from the drug industry cannot be genuinely independent. Moreover, manufacturers are now using promotional strategies that are particularly difficult to regulate. These include providing drugs at lower than the usual cost to ensure their inclusion in managed-care formularies, and using direct-to-consumer advertising to take advantage of the public''s lack of sophistication in interpreting scientific evidence. Our best hope of counteracting the power and influence of the drug industry lies in regulation by government agencies, whose interest is the protection of the public.     

Global Health Governance and the Commercial Sector: A Documentary Analysis of Tobacco Company Strategies to Influence the WHO Framework Convention on Tobacco Control

Background

In successfully negotiating the Framework Convention on Tobacco Control (FCTC), the World Health Organization (WHO) has led a significant innovation in global health governance, helping to transform international tobacco control. This article provides the first comprehensive review of the diverse campaign initiated by transnational tobacco corporations (TTCs) to try to undermine the proposed convention.

Methods and Findings

The article is primarily based on an analysis of internal tobacco industry documents made public through litigation, triangulated with data from official documentation relating to the FCTC process and websites of relevant organisations. It is also informed by a comprehensive review of previous studies concerning tobacco industry efforts to influence the FCTC. The findings demonstrate that the industry''s strategic response to the proposed WHO convention was two-fold. First, arguments and frames were developed to challenge the FCTC, including: claiming there would be damaging economic consequences; depicting tobacco control as an agenda promoted by high-income countries; alleging the treaty conflicted with trade agreements, “good governance,” and national sovereignty; questioning WHO''s mandate; claiming the FCTC would set a precedent for issues beyond tobacco; and presenting corporate social responsibility (CSR) as an alternative. Second, multiple tactics were employed to promote and increase the impact of these arguments, including: directly targeting FCTC delegations and relevant political actors, enlisting diverse allies (e.g., mass media outlets and scientists), and using stakeholder consultation to delay decisions and secure industry participation.

Conclusions

TTCs'' efforts to undermine the FCTC were comprehensive, demonstrating the global application of tactics that TTCs have previously been found to have employed nationally and further included arguments against the FCTC as a key initiative in global health governance. Awareness of these strategies can help guard against industry efforts to disrupt the implementation of the FCTC and support the development of future, comparable initiatives in global health. Please see later in the article for the Editors'' Summary     

Bioequivalence of generic aerosol bronchodilators: what are the issues?

I have attempted to address some critical issues relating to the introduction of generic aerosol bronchodilators in Canada. I approached Genpharm to obtain information on the data submitted to the HPB, including the number of subjects involved, but the company refused to divulge this information because it was concerned about the use of such information by its competitors. In addition to the in-vitro testing conducted by the HPB, should a single pharmacodynamic study be sufficient to demonstrate the safety and efficacy of a drug that serves such a critical role in the prevention of serious illness and possibly death? If so, what will constitute the minimum requirements for the design of such a study? In general, what should be the minimum standards required for safety, efficacy and bioequivalence of aerosol bronchodilators? The next phase rests with the provincial governments. What criteria will they use to determine whether a generic aerosol bronchodilator will be considered bioequivalent? It is essential that the criteria for bioequivalence be developed by experts, and ideally those criteria should be agreed upon and accepted by federal and provincial regulatory bodies before a product is given the status of bioequivalence. Unless such a step is taken it will be difficult to have confidence that products can be considered interchangeable. The issue of interchangeability of aerosol bronchodilators demands immediate attention. Regulatory agencies are caught between those groups with vested interests on both sides. Since patients will either benefit or suffer as a consequence of regulatory decisions, action must be taken to ensure that the best decisions are made. Scientists, clinicians and government officials should convene as soon as possible to formulate a satisfactory approach to this problem of interchangeability. The medical and pharmaceutical professions need reliable information, and patients should not be denied less expensive generic drugs if it can be determined that they are comparable to the innovator''s product.     

我国仿制药人体生物等效性临床试验研究室建设的现状与发展路径

我国开展仿制药一致性评价最主要的困难之一是临床试验资源不足,解决办法是考虑将生物等效性临床试验资格认定调整为备案 管理。因此,对备案的医疗机构建设生物等效性试验研究室是一个潜在的挑战。文章分析了国内当前具备生物等效性 / I期临床资质的 机构、分布、承担项目能力及生物等效性临床试验机构、药物分析实验室和合同研究组织之间的关系等,对仿制药生物等效性临床试验 研究室的建设内容和规模展开讨论,供业内及监管部门参考。     

Just Choices: Representations of Choice and Coercion in Sex Work in Cambodia

In global discourses about sex work, the image of the ‘sex slave’ has been influential in constructing the view of women working in the sex industry in developing countries as ‘victims’. This paper examines the perpetuation of such discourses through powerful lobbying groups and socially conservative governments. It argues that frameworks that situate women working in the Cambodian sex industry through a singular identity of ‘victim’ or ‘agent’ are inadequate in informing our understandings of sex work in the country. Based on ethnographic research and interviews with sex workers in the port city of Sihanoukville, Cambodia, this paper questions prevailing stereotypes of ‘trafficking victims' and the image of ‘defiled’ or ‘duped’ women and girls central to such frameworks. It examines the intricate intertwining of elements of individual choice and coercion in women's lives and illuminates how, in the transition to a market economy, women's choices are constrained by hierarchal structures such as gender, class and socio‐cultural obligations and poor employment opportunities.     

Pilot Study of Essential Drug Quality in Two Major Cities in India

Background

India is an increasingly influential player in the global pharmaceutical market. Key parts of the drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit drugs available in the market and to discuss how the Indian state and federal governments could improve drug regulation and more importantly regulatory enforcement to combat these drugs.

Methodology/Principal Findings

Random samples of antimalarial, antibiotic, and antimycobacterial drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard drugs (30% and 0% respectively), as was product heterogeneity, with some drugs being more or less frequently substandard (12% and 7% respectively).

Conclusions/Significance

In a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government''s current estimates. However, important spatial and product heterogeneity exists, which suggests that India''s substandard drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the drug regulatory system in India needs to be improved for domestic consumption, and because India is an increasingly important exporter of drugs for both developed and developing countries. Some poor countries with high burdens of disease have weak drug regulatory systems and import many HIV/AIDS, tuberculosis and malaria drugs from India.     

Follow-on Biologics: A New Play for Big Pharma: Healthcare 2010

The U.S. pharmaceutical industry plays a vital role in shaping the face of American healthcare. As an industry rooted in innovation, its continued evolution is inherent. With major patent expirations looming and thin product pipelines, the industry now must consider new directions to maintain growth and stability. Follow-on biologics, derived from living organisms and marketed after the patent expiration of similar therapies, represent a growing opportunity for big pharmaceutical firms, as discussed during Yale’s Healthcare 2010 conference in April. Key characteristics of follow-on biologics make them a worthwhile investment for big pharma companies: They command high prices, will likely have fewer entrants than generics due to high barriers to entry, and play to the existing strengths of big pharma firms. With the recent healthcare legislation providing the way for consistent Food and Drug Administration (FDA) regulation, the timing seems right to continue the push into this new and growing market.At a time when healthcare issues are on the mind of every American, it would serve us well to consider the future of one of the most influential players in the sector: pharmaceutical companies. National health expenditures for pharmaceutical products are hovering around 10 percent, meaning that one out of every 10 dollars that we, as a nation, spend on healthcare goes toward drugs. These drugs regulate our cholesterol levels, promote the growth of white blood cells in cancer patients, manage our restless leg syndrome, help us sleep better at night, and provide myriad other benefits to our health and well-being. Yet, for all the benefits that the pharmaceutical industry provides, it is also criticized by many for the expense of its products and the high profit margins that these products command. The growing popularity of biologics — treatments derived from living organisms, such as antibodies and interleukins — has particularly increased the price of drugs in the United States. The current price of the average biologic is more than 20 times that of a traditional, chemically synthesized small-molecule drug. There is a trade-off between high prices and innovative new therapies. Moreover, pharmaceutical companies themselves argue justifiably that prices account not only for the price of production, but also for the research and development (R&D) for that therapy as well as numerous others that did not make it all the way through the regulatory process and to the clinic.In recent years, we have witnessed the breakdown of the well-oiled innovation machinery of the traditional big pharma company. While R&D departments spent more and more (well over $1B per drug), they did not see promising results in the form of late-stage drug candidates [1]. Over time, this led to a strategic shift in portfolio management within big pharma companies toward an acquisition-heavy plan to build up their pipeline of drugs. In-house R&D projects were cut, and layoffs of scientific staff were rampant. This phenomenon continues, with 2009 bearing witness to the most mergers and acquisitions in the pharmaceutical industry to date. Industry-wide consolidation aimed to find complementary development projects and synergies in manufacturing and emerging markets. What has been the effect of all of this? The answer is not as hopeful as the pharmaceutical industry would have liked. A giant “patent cliff” still persists, referring to a number of blockbuster drugs that will go off patent over the next two years and cause a dramatic decrease in sales for big pharma firms. Without a strong pipeline to fill in the valley with new product sales, big pharma companies have begun scrambling to find new ways to generate revenue.Meanwhile, the biotech industry’s foray into therapeutics has been a wild success story. From the 1980s to the present, biologics have reshaped the face of medicine in many disease areas. The spawn of highly innovative, nimble biotech firms, biologic drugs are large, complex molecules grown in living cells rather than synthesized chemically like small molecules. For example, Enbrel is a fusion protein that acts as a tumor necrosis factor (TNF) inhibitor to stop inflammation. This drug is being widely prescribed for rheumatoid arthritis as well as psoriasis, among other indications, with sales last year reaching $5.9 billion, up 9.3 percent from 2008 [2]. Enbrel was first developed by Immunex and released in 1998. Immunex was acquired by a rival biotech firm, Amgen, in 2001 [3], and subsequent marketing of the drug in the United States was jointly undertaken by Amgen and Wyeth (now taken over by Pfizer in the mega-merger of 2009). Enbrel’s is the classic story of the modern biologic: a novel therapy developed at a small biotech firm and acquired or licensed up the food chain to feed bigger firms’ appetites for late-stage assets.Enbrel is by no means unique; there are many blockbuster biologics on the market. Like Enbrel, many of them will reach the end of their patent life soon. Enbrel’s patent expiration is set for 2012, at which time it will be exposed to potential competition from generic versions. Therefore, though there are many novel biologics therapies that can provide new ways of treating patients, there is also a huge opportunity for generic versions of biologics that did not exist even one decade ago. This opportunity is hard to quantify, but one recent estimate shows that biologics responsible for $20B in annual sales will go off patent by 2015 [4]. Unsurprisingly, small-molecule generics firms are flocking to this space. Teva, the world’s largest generics manufacturer, has partnered with the Lonza Group to make and sell so-called follow-on biologics. These treatments are similar, but not identical, to preceding biologics whose patents expired. Meanwhile, Novartis’s generics arm, Sandoz, has increased capacity in biomanufacturing to ramp up its efforts. Big pharma itself has made motions of interest in the business of follow-on biologics, as witnessed by the dedicated division of Merck, BioVentures, established in late 2008 for the development of follow-on biologics. Interestingly, even Pfizer is testing a follow-on version of Enbrel, now in phase 2 clinical trials [5]. With a big market opportunity and a number of firms interested, follow-on biologics will surely play an important role in shaping the future of the pharma industry.For large pharmaceutical firms, what is needed is a way to diversify and mitigate risk, a way to supplement their rollercoaster sales figures year after year. Follow-on biologics may be a smart play for big pharma companies. Like their generic cousins, biologics manufacturing has strong economies of scale that big pharma firms can leverage. But unlike generics, there are higher barriers to entry because of the technical challenges of manufacturing biologics and the necessary clinical proofs of equivalency. Pharmaceutical companies already are practiced at navigating the global clinical-trials arena and should be able to exercise a significant competitive advantage in this area, especially over the existing generics manufacturers attempting a play in the follow-on biologics market. It has been estimated that the investment necessary to bring a follow-on biologic to market is eight to 10 years and will cost $100-$200M [6]. This investment of time and capital is substantial and tends to favor larger firms with significant R&D budgets. However, to put the investment into perspective, this is only one-tenth of the cost of developing a full-scale innovative pharmaceutical product and has less associated risk of failure — a proposition that the big pharma industry should find appealing. Additionally, the trend for current follow-on biologics on the market in the European Union (EU) and United States has been to use traditional detailing and marketing practices to compete with branded products. This, too, puts big pharma at a competitive advantage over other players lacking an army of detailing pharmaceutical reps, who can use their established relationships with doctors and medical personnel to promote new follow-on biologics.One counter-argument to the case for a move into follow-on biologics is that the new healthcare reform, the Patient Protection and Affordable Care Act (PPACA), passed in March of this year will harm any would-be generic biologics makers with its 12-year exclusivity for branded biologics. However, while this length of time is significantly longer than the proposed five years that generics proponents pushed for, the surety of a secure path forward through the FDA for follow-on biologics outweighs the downside of lengthy biologics exclusivity. It is reasonable to hope that within two to three years, the FDA will have functional guidelines for the regulation of this nascent market. Now more than at any other time in the past, the ambiguity associated with government regulation is manageable. And if big pharma becomes more intentional about entering the follow-on biologics market, its powerful lobby, PhRMA, could influence the way that the details of the FDA regulations are written.If the pharma industry does find the follow-on biologics market appealing and makes a bet on it for supplementary revenue, what can we expect from the patient perspective? It could mean greater access at cheaper prices, but the dynamics are much more nuanced. The economics of the small-molecule generics market likely will not be transferrable to the follow-on biologics market. High barriers to entry, high fixed costs of manufacturing, and marketing expenses will more likely manifest themselves in a market that has a small number of firms with relatively small price drops upon introduction of follow-on therapies. In small-molecule generics, the price typically decreases by about 80 percent from the original branded drug price after one year of generic competition. However, in current follow-on markets in the EU, this has not been the case. Since its introduction of biosimilars regulation in 2004, the EU has successfully introduced numerous follow-on biologics for three classes of branded drugs. The results hint at what might be expected for U.S. firms: By 2008 in Germany, biosimilars had captured an estimated 14 percent to 30 percent market share and discounted prices by 25 percent [7]. The U.S. story of follow-on biologics will likely mirror that of EU biosimilars rather than that of small-molecule generics.With healthcare legislation passed and the inevitable refocusing on bending the cost curve in healthcare expenditures, big pharma firms may be able to boost their reputation with the public as well as their bottom line with a continued push into follow-on biologics. The decreased risk of approval and steady returns will help diversify pharmaceutical companies’ volatile revenue streams, while concurrently winning favorable public opinion by promoting price reductions for some of the most expensive drugs available. The cost savings to consumers will increase access for patients as FDA regulation is finalized and more and more follow-on biologics enter the market. This could be a win-win scenario for big pharma and for patients.     

Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?

Background

Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care.

Methods and Findings

Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition.

Significance

In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries'' bargaining power in price negotiations undertaken with originator companies.     

注册分类改革视角下药品数据保护制度效应分析

在国际趋势的压力下,兼受跨太平洋伙伴关系协定（TPP）影响,我国实施药品数据保护制度已成大势所趋。鉴于药品数据保护与药品注册审批体系紧密相关,我国化学药注册分类改革后,药品数据保护对医药产业发展必然会带来不同影响。结合我国分类注册改革新标准,在理论上对数据保护制度实施效果进行研究,进而探讨新注册分类下数据保护的实施对1至4类药品及医药产业的影响。