Info Service on Health Issues (Apr14/02)
No sofosbuvir patent in Egypt, but Gilead deal still expensive
Cairo, 8 April (Heba Wanis*) – Preliminary examination of the patent application on sofosbuvir, a major hepatitis C medicine, at the Egyptian Patent Office showed that it is unlikely to be patented.
The examination revealed that the “invention” does not satisfy the novelty and inventiveness criteria to be granted a patent. The final decision of Egyptian Patent Office has not been issued yet; however, it is clear that sofosbuvir will not be patented in Egypt. In the meantime, the Ministry of Health agreed with Gilead Sciences Inc., the US-based multinational pharmaceutical company, to pay $300 per bottle per month to purchase sofosbuvir for its national HCV treatment programme.
Gilead has filed an application at the Egyptian Patent Office to patent its product for treatment of hepatitis C virus (HCV), sofosbuvir, an oral direct acting antiviral (DAA). According to sources at the Egyptian Patent Office, sofosbuvir “is not new” and does not merit patent protection. Gilead has been notified of the result of the examination, but has not responded yet to the patent office communication.
In India, sofosbuvir is facing pre-grant opposition. The case has been filed by Initiative for Medicines Access and Knowledge (I-MAK) against Gilead at the Kolkata Patent Office. Grounds for the opposition are lack of novelty, lack of inventive step, new form of known compound and new use of known compound. Sources at the Egyptian Patent Office said that there is no need to file a similar case in Egypt, because examination alone is enough for the application to be rejected.
In the meantime, Gilead has been aggressively negotiating with the Egyptian Ministry of Health to register sofosbuvir (marketed as SovaldiÒ) and sell it to the government for its national HCV treatment programme. The price reached in this deal is $300 per bottle per month, equivalent to about 2000 Egyptian Pounds (EGP) per month, which is nearly the monthly income of an average Egyptian family.(1)Dr. Adel Adawy, Egyptian Minister of Health, called this price "a success".
The treatment course of sofosbuvir will either be three or six-months long; this is still to be determined by the results of clinical trials on genotype-4, the one prevalent in Egypt. That said, total cost of treatment will either be $900 or $1200.
HCV situation in Egypt
Gilead seemed to be rushing to get the Egyptian deal done since Egypt is the first country on their list for sofosbuvir registration. Egypt has the highest prevalence rate of HCV in the world, amounting to 14.7% in the general population, (2) with even higher rates in some geographical areas: the Nile Delta and Upper Egypt suffer rates of up to 28% and 26% respectively.(3) There are 8-10 million Egyptians carrying HCV antibodies, 5-7 million of whom have chronic HCV infections. Incidence rates are estimated at 2-6 per 1000 per year.(4) With such high rates, Egypt is a guaranteed market for Gilead to kick-off its sofosbuvir.
Cost of treatment and government funding
According to a recent report by Medecins du Monde, the agreed price would cost the Egyptian government five times its total expenditure on health in 2011 should all HCV patients receive sofosbuvir. (5) It is worth noting here that until 2011, the National Control Strategy succeeded only in treating 1.67% of patients with chronic HCV infection. Besides, the annual allocated budget of HCV control and treatment covers only 40% of the actual total costs of the programme. (6)
Dr. Wahid Doss, Head of the National Committee for the Control of Viral Hepatitis, explained that the Liver Institute will provide the treatment, and get paid by other government entities such as the Health Insurance Organisation and syndicates. The possibility of patient co-payment is also under consideration.(7)
The socioeconomic nature of HCV in Egypt and the very high out-of-pocket expenditure on health and medicines, both emphasise cost as a real hindrance to accessing treatment. The government programme remains underfunded and it is not clear how the government, represented by the Ministry of Health and National Committee, will mobilise the necessary funds for purchasing sofosbuvir.
Details of the agreement with Gilead were not disclosed. However, some of its terms were disclosed by Ministry of Health officials who attended the World Health Organization Global Partners’ Meeting on Hepatitis in Geneva on 27-28 March 2014. The private market price will be set at five times the government price, that is $4500, for a 12-week treatment course, and the deal will be subject to annual renewal.
According to Gilead, treatment of genotype 4 (GT-4) of HCV, which is the one prevalent in Egypt, is done using sofosbuvir combined with pegylated interferon and ribavirin. (8) Dr. Doss, however, mentioned that Gilead is pushing for a second option which is sofosbuvir alone for 6 months (an option which will guarantee an even bigger market for Gilead).(9) This six-month treatment regimen will not be adopted unless clinical trials on GT-4 in Egypt are concluded. According to Gilead, the results of these trials are not final and have not been published yet. (10)
Until now, it is not clear whether the negotiated prices include taking into consideration the added costs of pegylated interferon and ribavirin should a combination treatment be used.
The medicine price negotiations strategy in Egypt has always depended on securing a low price for government procurement in exchange for a higher one for the private market. Given the high percentage of out-of-pocket expenditure on healthcare in Egypt, this leaves a large segment of HCV patients outside the coverage of the government programme with the only option of having to pay out-of-pocket.
Gilead’s restrictive strategies for registration and voluntary licensing
Gilead presented its “HCV Treatment Expansion Programme”, which covered the registration and licensing of sofosbuvir, at the First HCV World Community Advisory Board (CAB) Meeting, in Bangkok last February, and had 22 countries represented.
Egypt was the first on the list of countries for registration of sofosbuvir. Criteria were based on HCV prevalence, disease awareness, regulatory pathway and timelines. Countries which followed Egypt on the list included Brazil, Mexico, Argentina, Nigeria, Dominican Republic and Haiti, India, Pakistan, Thailand, and others.
Voluntary licensing (VL) is an element of Gilead’s “Expansion Programme”. According to Gilead’s presentation, this element includes a list of countries which will be “generic enabled”, where “resources, funding and health infrastructure, are most tightly constrained”. The long list of countries included India, Kenya, Pakistan, Sudan, South Sudan, Tanzania, Zambia, Zimbabwe, among others.
According to Gilead, their VL agreements will accommodate “certain lower-middle income countries with very high prevalence of HCV and lack of funding”. Surprisingly, Egypt with local production capacity is not among the countries eligible for VL, despite being lower-middle income and host to the highest HCV prevalence in the world.
Why local production is important in Egypt
Pharmaceutical companies in Egypt expressed interest in producing sofosbuvir locally, and some have even started contacting generic producers for supplies of the active pharmaceutical ingredient (API). However, there is reluctance from the Ministry of Health to support their attempts, according to pharmaceutical companies, including representatives of the Egyptian Chamber of Pharmaceutical Industries. This became clear later as the issue did not appear on the agenda of Egyptian negotiators with Gilead.
Local production not only provides patients, and the government, with cheaper versions, but also creates competition which forces originator companies to reconsider their prices. There is precedence in Egypt in the case of HCV, when Minapharm produced a biosimilar version of Roche’s pegylated interferon, causing the price to go down.
Gilead is currently negotiating VLs in India, which will be among the first countries to produce cheaper generic versions of sofosbuvir. However, India will probably not be able to supply countries excluded from voluntary licenses and Egypt is one of those. (11)
(* Heba Wanis is a Researcher on Access to Medicines with the Egyptian Initiative for Personal Rights.)
Central Agency for Public Mobilisation and Statistics (CAPMAS). Indicators
of Income, Expenditure and Consumption for 2012-2013. November 2013.
Available at: http://www.capmas.gov.eg/pepo/c.pdf