[Ip-health] No treatment Ebola, high prices for hepatitis C drugs: Time to change the pharmaceutical research system

Mohga Kamal-Yanni mkamalyanni at Oxfam.org.uk
Thu Sep 25 07:33:39 PDT 2014


http://english.ahram.org.eg/NewsContentP/4/111544/Opinion/No-treatment-Ebola,-high-prices-for-hepatitis-C-dr.aspx 


No treatment Ebola, high prices for hepatitis C drugs: Time to change the 
pharmaceutical research system 

Dr. Mohga M Kamal-Yanni , Wednesday 24 Sep 2014 

The high state of anxiety about the Ebola virus and its possible spread 
throughout Africa has caused fear in the world. Effective vaccines and 
medicines to prevent and treat Ebola do not yet exist. There are too few 
cases to make it profitable for pharmaceutical companies to invest in 
research and development (R&D), and at the end of the day those who are at 
risk are too poor to pay high prices. 

When there is a profitable market, such as that for hepatitis C in the US 
and Europe, medicines are marketed at extremely expensive prices. 
Countries such as Egypt, which has a high burden of hepatitis C, cannot 
afford such high prices. 
Ebola and hepatitis C are both examples of the monopoly ownership system 
that allows pharmaceutical companies to control R&D and the price of 
medicines. 

The medicines currently under investigation for Ebola have raised a number 
of ethical questions. Some of the medicines, including ZMap, used by 
American, British and Spanish patients who have caught Ebola in West 
Africa, have not yet gone through clinical trials. It is not clear whether 
the medicines can treat Ebola effectively and safely, and there is minimal 
knowledge about their side effects. 

Given that the medicines are still at the experimental stage, they do not 
exist in sufficient quantity to treat all patients. Some say that health 
workers should have priority because they are most at risk and they are 
the ones at the forefront of the outbreak. The Gulf States are reported to 
be planning to buy the experimental medicine in case their citizens become 
infected[1]. 

There are currently 17 diseases identified by the WHO as ?neglected 
diseases? because of the lack of investment in R&D to prevent or treat 
them[2]. Thanks to civil society advocacy, there is now a spotlight on the 
plight of people affected by neglected diseases, so that more public and 
philanthropic funding is available. Yet Ebola and other haemorrhagic 
fevers have not even made it onto this list, which includes diseases such 
as bilharzias and leprosy. It is now painfully clear that a new list is 
much overdue. 
Large companies will not invest in R&D for rare and neglected diseases, 
due to the limited scope for profit. Current R&D for Ebola medicines is 
carried out by small biotechnology companies and is financed with public 
money. Throughout the history of medicine, public funding has played an 
essential role in developing breakthrough medicines, including for the 
treatment of HIV, tropical diseases and cancer. Yet this role has been 
ignored in favour of promoting strict intellectual property rules, so that 
the choice of targets for R&D is left to the market where monopoly 
protection will reap the greatest profit. It is neither ethical nor 
sustainable to leave decisions and financing for R&D to be dictated by the 
commercial interests of pharmaceutical companies. 

Marijn Dekkers, the CEO of Bayer, gave the game away when he said: ?We did 
not develop this medicine for Indians. We developed it for western 
patients who can afford it?[3]. 
The hepatitis C virus infects an estimated 180 million people around the 
world who mostly live in middle-income countries[4]. However, there are 
enough infected patients living in more affluent countries to make the 
market sufficiently profitable to attract pharmaceutical companies. 

Recently, a new class of medicines has been developed which acts directly 
on the virus and has a cure rate of over 90%. One of these medicines is 
sofosbuvir (Sovaldi), developed by Gilead and sold at US $1000 per pill. 
The 12 week treatment course would cost US $84,000 ? a price totally 
unaffordable in low and middle-income countries. Even high income 
countries are facing difficulties in paying such an exorbitant price. Some 
US insurance companies are instructing doctors to limit prescriptions of 
this medicine to specific patients. The French health minister has called 
on Europe to collectively negotiate a better price saying that the current 
cost would have grave implications for the French health system. This is 
the first time that the US and EU payers have widely and publicly 
questioned prices of new medicines[5]. 

By setting such a high price, Gilead has profited over US $5 billion from 
sales between January and June 2014[6]. The company has offered Egypt and 
Mongolia (both have a high burden of hepatitis C) a price of US $900 for a 
12 weeks course to be used in the public sector only[7],[8]. Yet even at 
such a reduced price, treating 5 million patients (less than half the 
estimated number of infected people) would cost Egypt US $4.5 billion - 
almost 2/3 of the country?s total current health budget of US$ 7.22 
billion for 2014/15[9]. 
While pharmaceutical companies use the cost of R&D to justify the high 
price of medication, this claim cannot be verified, as there is no 
transparency about the real costs to companies. The claim also ignores the 
contribution of public funding in preliminary research, and sometimes in 
clinical trials. 

The history of HIV has clearly shown that the most effective mechanism to 
decrease prices of medicines is through generic competition. In the year 
2001, the world ignored the millions dying of HIV when the price of the 
triple cocktail treatment was US $10,000 per patient per year. Now that 
generic competition exists in this market, the price has now dropped to 
around US $100, which has enabled 10 million people to now be on 
treatment. At the initial high price, these people would have been dying 
or dead. 
Unfortunately, such competition will be difficult because the World Trade 
Organization?s Trade Related Agreement of Intellectual Property Rights 
(TRIPS) Agreement enables monopoly rights over new medicines. As a result, 
the company that developed the drug, and thus owns the patents, can charge 
whatever price the market will bear. However, governments can use 
mechanisms such as compulsory licensing, which are legal under TRIPS, to 
break the patent monopoly and allow generic companies to compete and 
manufacture medicines marketed at lower prices. 

Ebola and hepatitis C are examples of diseases that would be treatable if 
the global system of incentives for R&D was designed with the interests of 
public health in mind. Instead, priorities and financing decisions for R&D 
are left to the market so that pharmaceutical companies continue producing 
the medicines that can make the highest profits rather than the therapies 
that are desperately needed for public health. As a result, new medicines 
will continue to be sold at the highest prices, and won?t be affordable to 
patients in developing countries and increasingly to patients in affluent 
countries. 

The time has come for all countries to commit a percentage of their GDP to 
medical research, providing a fund for the development of health 
technologies that would benefit all. Such a financing mechanism would give 
the decision on priorities for R&D and on affordability of prices back to 
the public, where it belongs. 
References 

[1]http://www.newtoday.ae/world/61848.html accessed 21 August 2014 
[2]http://www.who.int/neglected_diseases/diseases/en/ accessed 21 August 
2014 
[3]http://keionline.org/node/1910 accessed 23 August 2014 
[4]http://www.who.int/bulletin/volumes/90/7/11-097147/en/ 
[5]http://www.globalhealthcheck.org/?p=1630 
[6]
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1950450&highlight
= accessed 2 September 2014 
[7]
http://www.reuters.com/article/2014/03/21/hepatitis-egypt-gilead-sciences-
idUSL2N0MI1ID20140321 
[8]http://www.infomongolia.com/ct/ci/7948 Accessed 1 September 2014 
[9] FY 2014/2015 state budget announced, analysts weigh in Daily News 
Egypt 26 May 2014
http://www.dailynewsegypt.com/2014/05/26/fy-20142015-state-budget-announced-analysts-weight/
accessed 2nd September 2014 

___________________________________
Mohga (Dictating to the computer so please forgive silly mistakes) 
Mohga M Kamal-Yanni
Senior health & HIV policy advisor, Oxfam GB
John Smith Drive, Oxford, OX4 2JY, UK
UK Mobile   + 44 (0)777 62 55 884
Follow me @MohgaKamalYanni



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