TO WHAT EXTENT SHOULD GOVERNMENTS REGULATE THE PHARMACEUTICAL INDUSTRY?
In 2015, patients around the world spent fourteen billion dollars on the top-selling Humira prescriptions, that’s quite the size of Jamaica’s entire economy.[1][2] Let’s presume your doctor appointment happens in the UK. There on average, your prescription for Humira costs $1,362. When you visit a doctor in Switzerland, the drug will start at about $822. But if you see a doctor within the US, your prescription Humira will on average run $2,669. [3] This is only one example but there are several other situations where drug prices differ around the world since governments have different policies with their pharmaceutical industry. This regulation of the pharmaceutical industry through the government is to control the industry by taking care of securing funding as well as ensuring regulatory compliance.
Humira is the top-selling prescription drug in the world[4], because of this drug a woman with rheumatoid arthritis[5], a chronic inflammatory disorder that can affect more than just your joints[6], can wash her dog in the bathtub without overloading her joints. The price of Humira has risen since 2012 per patient. The Humira fee begins high and continues rising. A reason for this phenomenon is that the high prices are necessary to develop the Humira drug, due to the fact that the development of Humira takes a long time and is rather complicated.[7]
This leads me to the following research question: to what extent should governments regulate the pharmaceutical industry?
Specification Research Question
Currently, most governments regulate the manufacture and sale of pharmaceuticals in at least some way. [8] To impose guidelines on pharmaceutical companies, to guard their public against dangerous drug effects. These regulations often prolong the process of bringing new pharmaceuticals onto the market.[9] Countries that adhere to free-marketplace pharmaceutical pricing, such as Germany, commonly have better drug costs and, therefore also higher prices for orphan drugs. [10]
The research question, to what extent governments should regulate the pharmaceutical industry is described as; what the government can provide patients when there is more regulation in the industry.One aspect may be that the prices could drop. Another factor is the availability of medicines, the government could provide a larger range of drugs. Furthermore, poorer patients could be helped with this when the government regulates parts of the industry. A reason for this is that the prices could be more transparent which leads to uniform prices.
Availability, affordability, and transparency are issues in the pharmaceutical industry.[11] For example, Austria, the US, and the EU have been struggling to ensure affordable access to medicine for their patients. In lower-income countries such as Spain and Greece, medicines were sometimes brought on the market months after it first launched. Medicines prices vary significantly globally, this difference is not necessarily based on the economic status of the country. [12]
Key Terminology
First of all, one first needs to understand some of the following key terms to understand my further research. Securing funding is defined as, smaller companies having more chances of a drug being approved for the market, whereas ensuring regulatory compliance is described as, the question if pharmaceutical companies are 100% honest with their information.[13] Transparent drug prices are defined as equal priced drugs for all patients. [14] Personalized medicines (PM) are described as pills and remedies tailor-made to a patient’s genetic profile.[15] Personalized drugs are expensive because it is very costly to screen patients for such tailored-made remedies and to provide drugs that focus on people or slender groups. Lastly, orphan drugs are treatments for rare diseases.[16] Furthermore, orphan drugs receive special consideration from the FDA.
The Debate
I have divided my debate into two main perspectives, the economical and ethical perspectives, which are some of the cores of this debate surrounding in what areas the government should and should not control the pharmaceutical industry. Firstly, the question of whether medicine prices should be increased. One side of this debate argues that the high drug prices are needed due to high development costs, to fund expensive research projects to generate new drugs.[17] Furthermore, the high prices are essential to develop for example Personalized Drugs (PM) which takes the pharmaceutical industry more time and effort.[18] [19] On the other side, manufacturers should consider making their prices more transparent, meaning prices will be equal for all patients. Furthermore, making sure that all patients shortly will be able to purchase their medicine. [20] When health and well-being improve, health care costs will go down.[21] The ethical aspect, whether everyone should have equal medical care. On the one hand, only rich people and developed countries will be able to purchase expensive medicines.[22] [23] Furthermore, manufactures will only want to develop profitable drugs that affect rich countries.[24] The other side of this debate states that more people should get access to the needed medicines, reducing misery, suffering, and excruciating pain.[25] When pharmaceuticals are more transparent drug prices will not suddenly change in price.[26] Moreover, governmental control may perhaps reason less profitable and neglected drugs to be developed. [27] Finally, the government may stimulate the cooperation of manufactures in case of a crisis. [28]
The Methodology
This research report aims to answer the question, To what extent should governments regulate the pharmaceutical industry? I will come to my conclusion through comparative literary analysis of articles and arguments. I will analyse not only arguments and evidence but the credibility and reliability of the author as well. I will use reports, cases, and articles to find evidence for my chosen perspectives. I have divided my research question up into two main perspectives, the economical and ethical perspectives, which are some of the cores of this debate surrounding in what areas the government should and should not control the pharmaceutical industry.
The Economical Perspective
Are drug prices too high?
The following articles argue whether or not drug prices are too high.
In the article The link between drug prices and research on the next generation of cures[29], author Joe Kennedy argues that a large reason for high drug costs is that pharmaceutical industries use their profit from one generation of products to pay the high development cost of the next generation, meaning that the pharmacy invests in further research. Kennedy is a senior fellow at the Information Technology and Innovation Foundation (ITIF)[30]. ITIF is the most authoritative science and technology think tank in the world, claimed by the University of Pennsylvania.[31] As Kennedy has recruited and ran peer learning councils on how to respond to the challenges of the global economy, he has relevant economic expertise.
Kennedy provides background information with links to relevant articles, which shows that he has done a lot of research on the topic. This strengthens his arguments. Kennedy claims that another reason why drug prices are extremely high is that relatively few people suffer from a disease thus the cost of development must be spread over fewer patients. He supports this claim by the use of a new drug that a comparatively small number of people suffer from Zolgensma, which treats spinal muscular atrophy.
Furthermore, Kennedy claims that we should not reduce drug prices, because reducing drug prices will not only make companies cut back on their future research. The subsequent technology will advantage much less from discoveries. Kennedy provides statistics of retail prescription drug spending, annual changes in pharmaceutical spending, and drugs paid out of pocket. Thus, the argument is strong and supported.
Furthermore, Kennedy states that a government cannot impose significant price controls without damaging the chances for future research. He supports this argument by claiming countries that allow higher drug prices experience more innovation, benefit from a more competitive domestic industry, and more good jobs.
Finally, Kennedy imposes some possible solutions, stating that the purpose of his report is not to promote one policy over another. He believes that rising prices are likely to boost funding for future research. Moreover, he claims that the public policy should not prop the prices up as far as possible, but rather structure a well-functioning market. Kennedy supports this claim, which states that reforms could aim to reduce the cost of development which in turn would result in both lower prices and increased investment, which has benefits for all parties. He does not stay one-sided, which makes his arguments reliable.
In the article Personalized medicine: Better results, but at what cost?[32], Dan Mangan argues that Personalized Medicine (PM) is expensive because it’s hard to provide patients such tailored treatments and to produce medicines that focus on smaller groups of patients. As Kennedy claimed, only a few patients suffer from a specific disease, therefore, the price for them to pay will be high. Mangan who is a reporter covering politics for CNBC has spent almost five years covering health care issues[33]. Furthermore, Mangan provides background information with links to relevant articles and reports, which shows that he has done a lot of research on the topic.
Mangan argues that PMs are frequently crafted from organic fabric instead of synthesized medicinal drugs and as a result are extremely highly-priced to develop. Moreover, competitors are free to enter the market and sell their version at lower prices, however, the material may be cheaper and less expensive to develop. Furthermore, he argues that drug prices will not necessarily come down, as they do with other medications because those drugs lose patent protection. Mangan does not support this argument, which makes it a generalist statement.
Furthermore, Mangan uses Dr. Druh Kazi, a cardiologist, a professor at the University of California, San Francisco[34] to claim that higher prices will often be worth it and can be controlled through a variety of strategies. Kazi is an academic and has been referenced in more research.[35] Moreover, if prices get increased but the drug has measurable better outcomes, people would except that. Claimed by Dr. Marty Kohn, chief medical scientist, his extended training and experience in health care management, policy, and operations as well as is background information makes him a reliable doctor [36]
Overall, both Kennedy and Mangan give strong arguments as to why drug prices should stay high. However, they both fail to occasionally support some of their arguments. They do, however, make use of relevant articles, reports, and academics, meaning the supported arguments are strong. Kennedy’s and Mangan’s argumentation is balanced, and the thesis why statements of the articles do get proven.
In the article Would Greater Transparency And Uniformity Of Health Care Prices Benefit Poor Patients?[37] Authors David Ridley and Margaret K. Kyle argue that better-informed buyers will use their knowledge of lower prices to negotiate better terms from the seller. The article is specifically about what effects price transparency has on developed and developing countries, and how policies in the pharmaceuticals and hospitals will be affected.
Ridley is the Faculty Director for Health Sector Management at Duke University business school and has a Ph.D. in economics[38], and has done research examining innovation and pricing, especially in health care.[39] Kyle is a professor in economics[40]and a leading pharmaceutical industry expert.[41] The source of this article, Health Affairs, is known for its peer-reviewed healthcare journal and is described as “The Bible of health policy”[42], which makes the article more reliable.
First of all, the authors describe several effects of price transparency. Price transparency might reduce a buyer’s search cost and might help identify if companies obtain low prices. Secondly, it can make both buyers and sellers tougher negotiators. Buyers would have new information and know the price others pay for the product. On the other side, sellers will have extra opportunities to stop one buyer’s price cuts, which might cut the price for all buyers. Finally, more uniformed prices might lead to sellers offering one price to their buyers.
Ridley and Kyle argue that international price comparison could lead to a more uniform price. This might avoid the appearance of “unfair” price discrimination. Both authors react to price transparency as partly beneficial. On the one hand, developing countries who are paying more for their products than richer countries might benefit when the uniform prices are low.[43] However, if the prices will rise instead, price transparency might hurt those intended to help. Ridley and Kyle compare drug prices to developed and developing countries, claiming that there are many medicines in developing countries that are sold above average, however also some that are rather inexpensive.
Lastly, both authors argue that pharmaceuticals tend to avoid markets at low prices. A reason is that due to transparency the pharmaceuticals’ profit might fall which may lead to a reduction of new drug development. A reasonable same claim has been made by Edward Abrahams in STAT,[44] president of the PM Coalition, representing his knowledge on PM is reliable. The pharmaceutical industry focuses solely on the cost of the drugs rather than the value the drug can accomplish because they don’t want their profit to fall.
In the article In A Significant Step For Price Transparency, Trump Finalizes Rule Requiring List Prices In Drug Ads[45], author Avik Roy argues that the ultimate step in health care transparency is to require transparency in the cost of health insurance. His perspective is similar to David Ridley and Margaret K. Kyle, according to all authors they believe that price transparency will lead to more informed buyers. However, Avik Roy goes into this by examining health insurance, while David Ridley and Margaret K. Kyle analyze drug prices in general. Roy is a former senior fellow at the Manhattan Institute, founder of the Roy Health research and principal author of the Apothecary. [46] Although he isn’t an academic, his expertise is relevant to the topic of this article, due to much research he has done into the pharmaceutical topic.
Roy claims that the ultimate step in health care transparency is to require transparency in the cost of health insurance.[47] According to Roy, more than 90% of the cost is paid for by insurance. Unless there is transparency into how your health insurance is paid for, buyers might never know how much they are exactly paying for. Roy supports this example by use of Johnson & Johnson’s recent ad for its best-selling blood thinner, Xarelto, claiming that the monthly price is 448 dollars, but most patients pay between 0 dollars and 47 dollars per month once insurance has been considering. Moreover, Roy states that few patients know how much they pay for health insurance, because their premiums are taken out of it before their paycheck.
The second part of Roy’s argumentation is that the pharmaceutical industry believes when patients know exactly what they are paying for it might intimate them. Consequently, patients will not seek for needed medicines once they find out drugs are costly. Roy does argue that the point of transparency is not to discourage patients from seeking needed care. It is about providing them with more information. Roy provides an example for this statement. If the list price is 100.000 dollars, but the price after insurance is 50 dollars, it explains why your insurance costs are so high.
Lastly, the author provides a helpful method to achieve insurance transparency. Employers to disclose how much has been taking out of your account. One reason behind this is, that it will make workers understand how much their wages are.
Overall, both Roy and David Ridley and Margaret K. Kyle give relevant arguments as to why price transparency for both drug prices and health insurance should be implemented. Both authors emphasize that transparency will lead to more informed patients and provide relevant links to articles and reports which makes their claims more reliable. However, all authors don’t always support their claims, meaning the statements are not reliable in comparison to the authors in favor of.
Concluding the economical perspective. The aspect of supporting high drug prices have given strong arguments and relative links to further research. For example, the high prices are necessary for high development cost and PM’s. Furthermore, more of the arguments were supported by academics, reports, and articles in comparison to the aspect against rising drug prices. Thus, based on the economical aspect governmental regulation shouldn’t be mandatory in the pharmaceutical industry.
The Ethical Perspective
Should government regulation ensure equal medical care?
The following articles argue whether or not all patients throughout the world should receive equal medical care.
In the article, dying from a lack of medicine[48], author Tefo Pheage states, that globally 50% of the children under five die of major diseases such as Malaria, tuberculosis. On account of lacking access to appropriate and affordable medicines, vaccines, and other health services. Pheage his argument is supported by the World Health Organization (WHO), a trustworthy and valid organization claimed by an examination from the National Institution of Health (NIH) making this a strong argument.[49] The source Africa Renewal, a magazine that focusses on quarterly bases.
Pheage claims that many developing countries rely on public health facilities. However, these facilities are suffering from shortages of critical drugs, therefore, many patients die of curable diseases. To produce medicines a country must enforce regulations by the FDA, which are enforced by the US and other governments. Many developing countries require high skill drug production. Additionally, pharmaceutical companies are reluctant to offer support.
The pharmaceutical industry is unwilling to lower their prices, therefore letting millions of people die. According to Sarah Musick author of the article: Pharmaceuticals providing affordable medicine in developing countries [50]. The source is The Borgen Project, an organization willing to fight against poverty. The source has no academic relevance, however, the claims Musick makes are relevant for the main point of the ethical perspective.
In the past ten years more companies have doubled the number of medications providing developing countries, states Musick. A small group of pharma companies is making the bulk of medicines necessary for developing countries.[51] Keown is a journalist who primarily focusses on the pharma and biotech industries. Furthermore, he provides several relevant articles and reports, indicating he likely has at least some expertise on the topic, as it is pharmaceutically relevant.[52]A statement argued by both Musick and Alex Keown: for instance, nine companies who patent for HIV have implied flexibility for low- and middle-income countries to import supplies. Furthermore, according to the access to medicine index, seven drug companies are providing more medication to the poorest population in the world. [53]
Thus, this statement was claimed by both authors making it a more reliable claim.
The effect of these companies offering and supporting developing countries, allows them to receive treatments and medical needs. If more companies joined this group, for example, the top six companies: GlaxoSmithKline, Novartis, Johnson & Johnson, Merck KGaA, Takeda Pharmaceutical, and Sanofi, that would bring much needed – flexibility.
In the article, How Government Regulations Impact the Drug Sector[54], the author claims that government regulation in the pharmaceutical industry results in companies being encouraged to develop treatments for rare illnesses. Due to the fact, orphan drugs receive special consideration from the FDA, when the government has some regulation. The source of this article is Investopedia, which is the world’s leading source of financial content on the web, claimed by Forbes magazine.
“Availability of medicine is one thing, but affordability is another important factor”, states Pheage.
In the article, 2020 is three days old and drug prices are already jumping,[55] author Megan Cerullo a business reporter, meaning she has no relevant knowledge on the topic.Cerullo inserted a graph in her article, to provide clarity on her claims. The graph is what is relevant to answer the ethical perspective. Cerullo claims that drug prices have increased by 5% in 2020. The graph she uses to make her point, are drugs and their price increase in percentage, making her claims more reliable. One of the highest risen drugs in 2020 is Humira. As stated before, a drug with high development cost, meaning unfortunate patients cannot afford the drug. Despite, President Trump has claimed to reduce drug prices for all citizens, stated in the article: Trump administration announces historic action to lower drug prices for all Americans[56], by Britanny De Lea in the Fox Business, a right-center bias magazine. Author De Lea has no relevant knowledge; however, her arguments are generalist statements. Firstly, De Lea states, that Trump has introduced a delivery system to prevent providers from pocketing the discount themselves. Secondly, Trump wants pharmacies to allow to legally import prescription drugs from other countries. Finally, purchasing drugs at the same price paid by foreign countries. These three orders will lead to a massive reduction and therefore more patients can afford the drugs.
In the article, £300 million announced for community pharmacies to support them during the coronavirus outbreak[57], published by the Department of Health and Social Care. The article claims that the pharmacy received millions to continue its essential service during an outbreak. An outbreak, for example, the Coronavirus has to give the industries more pressure and concerns, however, the government has to give them support by ensuring them with money. This argument was supported by claims by Minster for Health Churchill, making it a reliable argument, due to her knowledge on health improvements and inequalities. The source of the article is GOV.UK, a reliable source covering for all government departments in the UK, stated in the Guardian.[58]
Overall, not all author nor sources were reliable, however, many had important claims and reports which were necessary to make this perspective. Therefore, the argumentation may have not been as strong, however, this was supported by several articles, reports, and graphs.
In the article, Drugs for the Poor, Drugs for the Rich: Why the Current R&D Model Doesn’t Deliver[59], author Dr. Manica Balasegaram for Médecins Sans Frontiers in the PLOS. Dr. Balasegaram is head of the clinical program for neglected drugs, indicating he knows why developing countries don’t always receive needed medicine. PLOS is a scientific website, to publish scientific literature articles based on all topics, the source is based on evidence through the use of credible scientific sourcing, making it a reliable magazine. Balasegaram claims that pharmaceutical attitude towards developing countries is that the industry doesn’t develop necessary drugs for developing countries, but rather for western countries who can afford the drug prices. This claim was confirmed by the pharmaceutical company Bayer, one of the largest pharmaceutical companies in the world, making it a trustworthy company, meaning it makes this argument strong. The author supports this claim by utilizing an example that makes the argument stronger. A British and Swedish company AstraZeneca announced halting their process of malaria and tuberculosis. Instead, they want to focus more on drugs for cancer and diabetes patients, while these diseases will potentially affect plenty of people in rich countries. Finally, Balasegaram states that a reason behind this change of plan is that the pharmaceutical industry wants to achieve high sales by enabling these profitable drugs.
Balasegaram’s argument is supported by an article from the Guardian, Rich countries ‘blocking cheap drugs for developing world’[60], by Sarah Boseley. She has won multiple awards for her work on HIV/ Aids in Africa. As well as Balasegaram, Boseley claims that pharmacies are blocking developing countries from the world to obtain affordable drugs. Boseley confirms this claim by use of Oxfam, most reliable qualities as a non-profit retailer[61], claimed by a report from UK Fundraising, which makes Oxfam a reliable source.
Not only does Oxfam as a company help to support this claim and making it a more reliable statement, but Boseley also refers to Celine Charveriat, head of Oxfam’s campaign, which makes her trustworthy, since she has relevant expertise. Charveriat claims, that pharmaceutical companies have broken the Doha Declaration[62], a deal to give poor countries access to cheap medicines. She supports this claim by a report, claiming that companies prefer to develop more cancer and diabetics drugs since more developed countries will profit. However, cancer and diabetic patients are expanding faster in developing countries. Finally, the article made use of a case study, making their arguments stronger. The study provides a sixty-year-old woman who is suffering from cancer. She has no available medicines that are exported to her country, therefor she is using inexpensive generic drugs. This case study indicates that pharmacies are more focused on what areas they can profit the best.
Lastly, the article, The impact of big pharma on Covid-19[63], by GlobalData Healthcare in Pharmaceutical Technology. GlobalData is a premier source containing an analysis of more than 1000 expertise and researcher[64], claimed by Market Research.[65] The Pharmaceutical Technology is an application of scientific knowledge or technology to pharmacy, claimed by a report from LONGDOM.[66] Pharmaceutical companies have taken center role during the coronavirus. Resulting in positive growth in the stock market, claimed by two international pharmaceutical industries, Gilead and Eli Lilly., making this argument supported. GlobalData claims that pharmaceutical companies are using their capabilities to support their patients during a pandemic. All three authors have claimed that the industry wants to develop only profitable drugs, which is claimed in this article as well, making this claim strong. Industries are supporting diseases they believe are important to treat, such as diabetes and cancer.
Overall, the argumentation in these three articles is strong and in correlation, especially due to the scientific sources and the author’s and company’s expertise. Again, having scientific expertise strengthened these article’s arguments. All articles assume, that pharmacies provide profitable drugs for developed countries since they believe they will profit. This is their main claim and they all support this through an expert or report, which makes their perspective strong. Together, these three articles strengthen each other: they prove why pharmacies tend to sell their drugs in rich countries.
Concluding the ethical perspective, the aspect against equal medical care contains the best scientific magazines and articles. In comparison to the aspect for equal medical care, the aspect against holds articles strengthening the arguments stated, which makes the statements more reliable. Thus, based on the ethical perspective the pharmaceutical industry doesn’t need governmental regulation.
Conclusion
I have now analysed the arguments in favor of and against my two sub-questions. From the comparison on the first question, (are drug prices too high?) I concluded that the reasons for high prices are due to high development costs and this could potentially be solved by more transparent pricing. The side of the debate that argued that drug prices are indeed too high, lacked evidence. The arguments and evidence that stated drug prices are not too high were stronger and more reliable. Applying this to the main research question, this comparison indicates that the government should not imply regulation on the pharmaceutical industry in case of price regulation.
From the comparison of the second statement (Should government regulation ensure equal medical care?). I concluded that pharmaceutical industries want to develop profitable drugs that affect rich countries. There was little reliable evidence nor little to none supported claims stating that everyone should receive equal medical care. On the other side, the arguments and evidence arguing that not everyone should receive medical care, were strong and reliable. Therefore, when I base my answer on the ethical aspect, I must conclude that government regulation is not necessary to provide everyone with equal medical care.
When I conclude the results of these two comparisons, by evaluating the strengths and weaknesses of the arguments. I can conclude that the strongest perspective is the one against equal medical care. Of course, not giving everyone equal medical care might not be the best solution, as explained developing countries also need affordable and available medicines. However, this perspective contained the best scientific magazines and articles. Furthermore, the perspective contained articles strengthening each other’s claims, making it the most reliable and strong perspective. Therefore, the answer to the research question is that the government should regulate the pharmaceutical industry to no extent and stay out of matter.
Of course, we must do further research into the question of whether to what extent the government should regulate the pharmaceutical industry. This issue has been debated for quite some time. Therefore, we can already conclude some things, however, in several years those arguments may change and that may also change the answer to this research question. It is important to conduct further research, for example, to see if the pharmaceutical industry indeed needs high prices for their drugs, or they maybe they could drop some of their prices.
Furthermore, I limited my research to the economical and ethical perspective. I did this because drug prices have become a focal point in the debate. Patients who believe their prescriptions are too expensive or inexpensive. However, there are many more forms of drug price regulation I may have not discussed. For example, the process of testing, developing, and marketing of medicines. I have looked into the development and marketing, but briefly in the testing aspect. I also limited my research to the ethical perspective, since that has also become an important factor of this research report. When thinking about drug prices, attention is drawn to fortunate and unfortunate patients who can or cannot afford to purchase their needed medicine. This ethical perspective has also an enormous widespread debate. Therefore, what can be done is, for example, looking into the developing and developed countries individually more, due to the fact in each country medical care is different and in this paper, a more generalist conclusion has been drawn.
Reflection
Writing this research paper has completely changed my perspective on the issue of the regulation of the government in the pharmaceutical industry. I used to believe that government regulation could only bring positive effects for the unfortunate patients because I always thought pharmaceutical industries earned unfairly too much. However, the arguments stating that pharmaceuticals want to sell profitable drugs in profitable countries were stronger than the arguments against. This changed my perspective, and I now believe that the government should not regulate the pharmaceutical industry, but instead let the pharmaceutical industry continue how they operated before.
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[21] Roy, Avik. “In A Significant Step For Price Transparency, Trump Finalizes Rule Requiring List Prices In Drug Ads” Forbes, 8 May 2019, https://www.forbes.com/sites/theapothecary/2019/05/08/in-a-significant-step-for-price-transparency-trump-finalizes-rule-requiring-list-prices-in-drug-ads/
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[29]Kenndy, Joe. “The link between drug prices and research on the next generation of cures.” Information Technology & Innovation Foundation, 9 September 2019, https://itif.org/publications/2019/09/09/link-between-drug-prices-and-research-next-generation-cures.
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