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Hepatitis C cure, sofosbuvir, turns 5 years old: The vast majority of people still have not been treated
Advocates scandalized that Gilead’s hepatitis C profit have raked in US$25.8 billion, which could have treated everyone while still earning US$16 billion in profits.
6 December 2018, Paris, France, New York, NY— People living with hepatitis C, access to medicines activists, and the medical community around the world “mark” the fifth birthday of the first all-oral, one dose per day cure sofosbuvir (Sovaldi®), launched by Gilead Sciences. A global hepatitis C coalition has released a fact sheet revealing treatment barriers that resulted in only 1.85 million of the 71 million people
worldwide who need treatment, receiving Gilead’s sofosbuvir-based drugs, largely due to pricing, patents and registration delays.
Since 2013, Gilead reaped US$58.6 billion in hepatitis C product sales, of which 25.8 billion are estimated profit(1), with a fraction of these earnings invested in research and development. Instead, in 2017 alone, Gilead spent US$14.8 billion rewarding shareholders. This amount is more than sufficient to treat everyone with chronic hepatitis C with generic versions. “The mind-boggling profits that Gilead earned since the launch of sofosbuvir could treat every person currently waiting for the hepatitis C cure while earning over US$16 billion in profits for shareholders. This is a massive transfer of wealth from public health systems and sick individuals to a handful of pharma
executives and shareholders,” said Annette Gaudino, HIV/HCV Project Director, Treatment Action Group.
The breakthrough direct-acting antivirals (DAAs) can cure over 90% of people with chronic hepatitis C, and generic versions show similar safety and efficacy rates as brand drugs. Generic competition to accelerate the number of people who start treatment is stalled due to Gilead’s and its sub-licensees’ delay or failure to register their drugs, blocking access to the cure in countries with some of the highest rates of hepatitis C.
“In Malaysia, even though we fall under the voluntary license, the uncertainty of marketing approval by drug regulators was a possible delay in accessing affordable sofosbuvir. Instead, it was important to use a compulsory license to fully guarantee affordable treatment for people with hep C,” said Edward Low, Director, Positive Malaysian Treatment Access & Advocacy Group.
In addition, treatment activists investigate and challenge the merit of Gilead’s patent on sofosbuvir and sofosbuvir-based treatment combinations. Following several high-profile patent challenges in Brazil, India, and the Ukraine, a coalition of European Civil society organizations and patient groups(2) have recently appealed against the decision by European Patent Office for rejecting their opposition to the patent granted to Gilead for sofosbuvir. “Unmerited patents in Europe are giving pharmaceutical corporations the monopoly power that allows them to charge exorbitant prices for many lifesaving drugs,” said Gaëlle Krikorian, Head of Policy at MSF’s Access Campaign. “The excessive prices Gilead is charging for sofosbuvir have kept this breakthrough medicine away from millions of people with hepatitis C – in Europe and around the world. What is the point of medical innovation if people and health systems cannot afford the products coming out of it?”
(1) Gilead’s profit margin was calculated with the ratio net incomes attributable to Gilead divided by the total revenues per year and applied to HCV products sales per year, yearly figures are coming from Gilead’s annual earning reports.
(2) Médecins du Monde (MdM), Médecins Sans Frontières (MSF), AIDES (France), Access to Medicines Ireland, Praksis (Greece) and Salud por Derecho (Spain).
Sofosbuvir’s fifth birthday is a reminder of how Gilead privatized publicly funded research. In 2011, Gilead acquired Pharmasset, the original developer of sofosbuvir, which relied on US$880 million in public funding by the National Institutes of Health. Gilead then priced a 12-week treatment course of sofosbuvir at US$84,000 versus the estimated US$42 it costs to manufacture generic sofosbuvir, including a 10% profit
margin and a 27% tax on the profit margin. “It is scandalous that five years on we have not had the enormous impact that we should with the first safe, highly tolerable cure,” said Olivier Maguet, Drug pricing and health systems campaign responsible at
Médecins du Monde. “An estimated 5 million people need to be treated each year to curb the epidemic— without addressing the pricing barriers, delays in registration, and limited generic competition the hepatitis C cure will be a failure in medical history and for humanity.”
The hepCoalition global advocacy movement demands:
o Drop patents on sofosbuvir in all low- and middle-income countries!
o Drop the prices of Sovaldi® in high-income countries and immediately register sofosbuvir in all low and middle-income countries!
o Remove unethical anti-diversion requirements to ensure that they do not limit or impede patient access!
o Register generic direct-acting antivirals in all the countries!
o Develop national treatment programs and procure affordable generic direct-acting antivirals!
o Enforce strict patentability criteria and issue compulsory licenses to overcome patents
blocking access to affordable treatment!
o Develop alternative and more sustainable models for medical research and development!
World Health Organization:
o Prioritize the prequalification process of generic DAAs!
o Stop ignoring the HCV epidemic and allocate funding to respond to the global epidemic!
About hepCoalition: The hepCoalition is a global advocacy movement for the access to hepatitis C diagnostics, treatment, and support for people living with a high risk for the hepatitis C virus (HCV) in low and middle-income countries, and particularly for people who use drugs and people living with HIV/HCV.
Médecins Sans Frontières: To know more about the development of sofosbuvir, a true breakthrough drug for hepatitis C, watch this video: When Big Pharma plays for keeps, who wins and who loses?
Oxfam – Prescription for Poverty: https://www.oxfam.org/en/research/prescription-poverty Americans for Tax Fairness – Gilead Sciences: Corporate Tax Dodger:
Treatment Action Group – Pharma Shell Game: http://www.treatmentactiongroup.org/HCV/pharma-shellgame
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Wednesday, 24 Oct 2018
KUALA LUMPUR: The 2,000 treatments allocated for Hepatitis C patients at government hospitals for this year have been used up, and an NGO is urging the Government to replenish the stock.
Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) director Edward Low said the Health Ministry had made the medication available at 22 government hospitals nationwide but the 2,000 treatments had been used up as of Oct 1.
“We would like to urge the new Government to continue treatment for patients with Hepatitis C who have been on the waiting list for many years, he said in a statement on
Low said the government had to continue importing more medication in line with the goal of eliminating Hepatitis C by 2030, as set by WHO.
From March, the Health Ministry had been bringing in the generic version of Sofosbuvir, which is the backbone combination treatment for Hepatitis C, after the previous government issued a compulsory licence to authorise a local import company to bring in the generic drug, making it affordable and accessible to Malaysians.
Direct acting antivirals, also known as DAAs, have little or no side effect compared to previous medication regime using Interferon.
In July last year, The Star carried a front-page story highlighting the plight of about 400,000 Malaysians who suffered from hepatitis C, with only a fraction of them being able to afford the medication which can cost up to RM300,000 for the full course of treatment.
Malaysia was not given special prices for the newer drugs by pharmaceutical companies because it was considered a middle-income country. Subsequently, the Cabinet gave approval to issue a government-use licence to enable the import of generic versions of the Hepatitis C drug Sofosbuvir, and it was made available in government hospitals in March.
Even if medicine is patented for 20 years, the government has the right to issue compulsory licensing under the rights, flexibilities and safeguards vested to World Trade Organisation members by the agreement on Trade-Related Aspects of Intellectual Property.
The government-use licence only applies to drugs used in government health facilities.
Thursday, 25 Oct 2018
KUALA LUMPUR: The Health Ministry has redistributed limited Hepatitis C drug stocks to hospitals to ensure patients get their supply while waiting for new supplies to arrive.
Health director-general Datuk Dr Noor Hisham Abdullah (pic) said that the current Sofosbuvir 400mg tablet stock was enough for patients while the Daclastavir 60mg tablets were limited.
“The stock for the Daclastavir 60mg tablets is expected to arrive in the first week of November for new patients. There is enough stock for patients currently undergoing treatment,” he said in a statement on Thursday (Oct 25).
The latest Hepatitis C treatment uses a combination of two direct-acting antivirals (DAAs) Sofosbuvir 400mg and Daclatasvir 60mg tablets, he said.
Dr Noor Hisham was responding to a statement by Positive Malaysian Treatment Access and Advocacy Group which said that the Hepatitis C drug is out of stock in government hospitals as of Oct 1.
Thursday, 25 Oct 2018
KUALA LUMPUR: A patient who is on Hepatitis C treatment has to stop his treatment after the allocated 2,000 treatments for this year ran out.
The self-employed patient, who wanted to be known as Zack, 38, said the hospital he went to had run out of stock of the medicine and his treatment will resume once stock is available.
“I hope the government will bring in the stock quickly because, not only I, but many of my friends, are waiting to be treated,” he said in a telephone interview.
Zack, who lives in Sungai Petani, Kedah, said he has liver scarring and started the treatment in July and had only completed 12 weeks of treatment.
“The doctor told me last month that he wanted me to be on the medication for up to six months. I was told to wait for the stock, then only continue with treatment,” said Zack, who was treated with a combination of the generic version of Sofosbuvir and Daclatasvir.
The former drug user said four of his friends had died of Hepatitis C, two in April and June.
“I am concerned because one of my friends looked well and then suddenly fell sick and died. Just before he died, his stomach was bloated,” he said.
Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) director Edward Low said the Health Ministry has made the medication available at 22 government hospitals nationwide but the 2,000 treatments allocated for this year have finished as at Oct 1.
“We urge the new government to continue treatment for patients with Hepatitis C who have been on the waiting list for many years,” he said in a statement on Tuesday.
Low said the government has to continue importing more medication in line with achieving the goal to eliminate Hepatitis C by 2030 as set by WHO.
“Elimination of Hepatitis C will fail without the new government’s commitment.
“We hope in the coming Budget 2019 announcement, the government will have allocation for a national Hepatitis C programme in public health care services,” he said.
From March, the Health Ministry had been bringing in the generic version of Sofosbuvir, which is the backbone combination treatment for Hepatitis C after the previous government issued a compulsory licence (CL) to authorise a local import company to bring in the drug, making it affordable and accessible to Malaysians.
This direct-acting antivirals has little or no side effects compared with previous medication.
In July last year, The Star carried a front page report about 400,000 Malaysians with Hepatitis C who could barely afford the full course of treatment that could cost up to RM300,000.
Malaysia was not given special prices for the newer drugs by the pharmaceutical company because it is considered a middle-income country.
The Cabinet then gave approval to issue a government-use licence to enable the import of generic versions of Sofosbuvir drug even though it is still patented, as provided for under the rights, flexibilities and safeguards vested to World Trade Organisation members through the Trade-Related Aspects of Intellectual Property agreement.
Another patient identified as Camelia, 41, said he had been waiting for 18 years for Hepatitis C treatment and hoped the government could replenish and bring in more medicine because 2,000 treatments are not enough to treat about 400,000 patients.
“Although my liver shows no scarring yet, the longer the wait, the higher the risk of scarring. That’s my concern,” said the finance manager, adding that it will cost more and will take longer to treat once that happens.
The doctor wanted to start him on treatment on Oct 1 but the medicine had run out of stock, he said.
For Immediate Release
23rd Oct 2018
Hepatitis C elimination will fail without new Malaysian government commitment.
Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) would like to strongly urge the new government of Malaysia to continue treatment to patients with Hepatitis C who are in the waiting list for many years. An estimated 380,000 Malaysians were infected with Hepatitis C.
Since March 2018, The Ministry of Health, Malaysia has brought the latest affordable medication, Sofosbuvir, which is the backbone combination to treat all type of Hepatitis C. This Direct Acting Antivirals also known as DAAs has little or no side effect compared to previous medication regime using Interferon (IFN).
MOH has made the medication available at 22 government hospitals nationwide. However, we understand that 2,000 treatments have finished as of 1st Oct 2018, and the government has to continue importing more medication in line with achieving the goal in an elimination of Hepatitis C by 2030 as set by WHO.
We wish in the coming National Budget 2019 announcement to have a budget allocation for the National Hepatitis C program in public health care services.
Contact director. Edward Low
Positive Malaysian Treatment Access and Advocacy Group (MTAAG+)
Email : email@example.com
H/P : 012- 3278 812
Website : https://mtaagplusmalaysia.wordpress.com/
KUALA LUMPUR: Malaysia, represented by its Health Minister, Dr Dzulkefly Ahmad yesterday declared its commitment to ending the tuberculosis (TB) epidemic by 2035 at the High-Level Meeting on the Fight to End TB, at the United Nations (UN) headquarters in New York.
Dr Dzulkefly, in a statement today, said the burden of TB for Malaysia was still significant with a notification rate of 81 per 100,000 population and a mortality rate of 6.5 per 100,000 population in 2017.
“TB can be eliminated by ensuring universal access to high-quality diagnosis, treatment and care of all forms of TB, including multi-drug resistant TB (MDR-TB).
“Malaysia as an upper higher middle-income country pledges that the cost for rapid molecular test and anti-TB treatment for drug resistant TB be reviewed, so that more people can benefit from this test and treatment.”
He said cooperation between the public and private sectors, and socio-economic and psychosocial support from the community were also important factors for successful TB treatment and outcome.
Malaysia, he added, was committed to implementing, monitoring and evaluating the strategies proposed in the National Strategic Plan for Tuberculosis Control (2016-2020) with full support and engagement of a wide range of stakeholders. – BERNAMA
THE PHARMACEUTICAL company for an important HIV/AIDS drug that combines Lopinavir and Ritonavir did not file for patents on the two base compounds in Malaysia.
However, between 1999 and 2006, several secondary patents were filed on the compounds and granted by the Malaysian intellectual property office.
“All of these increase the patent life of the drug by about another 10 to 12 years even though the base compounds are no longer under a monopoly in Malaysia and anywhere in the world,” says Third World Network legal advisor S. Sangeeta, pointing out the irony of drug patent issues.
The Malaysian Competition Commission review of the pharmaceutical sector revealed that the Health Ministry is paying high prices for this HIV/AIDS drugs – the patented drug costs US$1,489 (RM6,112) per patient per year under a Health Ministry procurement contract, while a generic version from India can be obtained at US$268 (RM1,100).
That would be about 82% savings for the Government if it had been able to gain access to the generic drug, says Sangeeta.
“When granting drug patents to pharmaceutical companies, the Malaysian patent office has to ensure that the invention is new, involves an inventive step and is capable of industrial application.
“But if countries loosely define the criteria, they can expect many patents being registered that extend the monopoly period and this delays generic versions from entering the market,” she says, adding that prices drop significantly, up to 90%, when there is robust generic competition.
Among the strategies used by pharmaceutical companies to prevent the entry of generic competition is a practice commonly known as ‘patent evergreening’ where multiple secondary patents are claimed over a pharmaceutical compound, patents over different forms such as crystals, liquids, tablets or heat-stable forms, uses, combinations, formulations and even dosages, she says.
It is important, that the ministry responsible for intellectual property and the patent office apply rigorous patentability standards on pharmaceutical patent applications, with the aim of avoiding secondary patents and patent evergreening, she says.
Sangeeta says that over the years, data from the US Food and Drug Administration shows that the number of new chemical entities for medicines has dropped since 1994, but the number of patents registered have increased, the US being usually the first country for patent filing.
This growth in pharmaceutical patents is a problem in developed and developing countries.
She also says that an Inquiry by the European Commission in 2009 revealed that in relation to 219 drugs, out of the 40,000 patents applications granted and pending, 87% were secondary patents.
“That means a large proportion of the patents granted are trivial patents,” she says.
The same inquiry found an estimated loss of around three billion Euros due to delays in the entry of generic products caused by misuse of the patent system, she says.
In South Africa, a study found 92 secondary patents were granted for 24 cancer medicines, with 74 likely to block competition from generic versions, she says.
She says there are lessons to be learned from other countries.
India, for instance, has a patent law which generally does not recognise patenting of new forms or uses of a known substance while Argentina has set up strict guidelines for the examination and grant of pharmaceutical patents.
Sangeeta believes there is a need for more sensitisation of the effect of the Malaysian patent office’s work on prices of medicines and access to medicines in Malaysia.
“If the Government does not ensure application of strict criteria for the examination of pharmaceutical patent applications, the prices of many life-saving treatments are going to remain high, and consequently, inaccessible to many patients.
“The bar has to be much higher, because now, many frivolous patents are being granted,” she says.
In 2016, the Report of the United Nation Secretary General’s High Level Panel on Access to Medicines recommended that World Trade Organisation Members adopt and apply rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants to curtail the evergreening of patents, and to award patents only when genuine innovation has occurred.
Sangeeta believes another measure that Malaysia can take to ensure only real inventions are patented is to introduce administrative pre- and post- grant oppositions system to patents.
She says that is because the court system is too time consuming and expensive.
“The opposition system will help patent examiners to conduct more rigorous examination of patent applications and have better examination practices. We are proposing the instituting of this opposition systems and that it be an administrative procedure and not a court case,” says Sangeeta.
Before a patent is granted, anyone who has an interest to file an opposition, such as generic drug companies or patient groups, could file an opposition before the patent office, showing why the patent should not be granted, she says.
A similar administrative procedure would apply after the granting of the patent in the form of a post-grant opposition system, she adds.
“Internationally, this has been found to be an important tool to ensure that patents are not wrongly granted,” she says, noting that this had a huge impact on facilitating access to affordable medicines in many developing countries.
“This would be especially beneficial and life-saving for patients suffering from cancer, HIV/AIDs, Hepatitis C, and rare diseases who pay very high prices for treatments,” she says.
KUALA LUMPUR, Aug 16 — The Ministry of Health has suspended a scheme by pharmaceutical companies that provides expensive new medications, which are unavailable in public hospitals here, for free.
The move will potentially affect thousands of patients suffering from cancer and rare diseases.
The Health Ministry’s Pharmaceutical Services Programme website announced last Monday the temporary suspension of the Patient Access Scheme (PASc) that involved free provision of drugs “until further notice”.
The Ministry of Health (MOH) also sent a letter to pharmaceutical companies yesterday to inform them that it has decided to put on hold all PASc applications involving free medications for the time being, after a meeting between the ministry’s Pharmaceutical Services Programme and Health director-general Datuk Dr Noor Hisham Abdullah on August 9.
“For YBhg Datuk/ Datin/ Sir/ Madam’s attention, this division has been requested to obtain views from the National Audit Department on the issue of civil servants’ integrity in the acceptance of free packs upon the procurement of drugs,” Dr Kamaruzaman Saleh, director of the Health Ministry’s Pharmacy Practice & Development Division, said in the letter dated yesterday sighted by Malay Mail.
An industry source explained that the MOH was treating the PASc — in which many pharmaceutical companies provide certain expensive innovative drugs to a limited number of patients for free after selling other medicines to the government — as if it was a “gift” that violated government ethics and integrity guidelines.
“Putting this programme in the same classification as if was some form of ‘imbuhan’ or unethical incentive such as a paid holiday in Bali is not only erroneous, it risks harming and denying the chance and possibility of patients to be treated with better and much needed treatment options,” the source said.
Malay Mail understands that incoming PASc applications were suspended while pending ones were denied. The fate of current PASc programmes is uncertain.
Prime Minister Tun Dr Mahathir Mohamad said last month that ministers would be prohibited from receiving expensive gifts like vehicles and they would only be allowed to accept food, flowers, or pewter plaques.
Malay Mail reported in 2016 Roche Malaysia as saying that since 2007, it has helped more than 4,000 cancer patients get access to medicines through its patient assistance programme, or PASc, that provides drugs for free.
The pharmaceutical company told Malay Mail then that most of its life-extending medications were provided through that programme, as many of these drugs are not available on the MOH Medicines Formulary that lists the drugs provided in MOH hospitals here.
A kidney cancer patient, who was taking a targeted therapy drug he received for free on Pfizer’s patient assistance programme that was not available in public hospitals here, told Malay Mail in 2016 he could live a normal life despite his Stage Four diagnosis in 2006.
According to the Health Ministry’s PASc proposal submission guideline, the scheme includes both existing drugs in the MOH Medicines Formulary and those outside it.
“Patient Access Scheme (PASc) is a scheme proposed by pharmaceutical companies and agreed upon by the Ministry of Health (MOH), Malaysia in order to improve access to medicines which are likely to have high budget impact either due to high treatment cost per patient and/or large volumes of use,” said the guideline.
“This scheme may address the rising cost pressure, consumer demands and uncertainties, while attempting to provide patient access to innovative care within finite budgets.”
When contacted for comment on the suspension of the PASc, Deputy Health Minister Dr Lee Boon Chye told Malay Mail: “We postponed PASc implementation at this point of time for us to have further discussion with Audit Negara”.
“Need to discuss internally to comply with audit standard,” he said.
Dr Noor Hisham did not respond to queries outside office hours.