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The EC is still trading away access to medicines By Leïla Bodeux, Policy Officer, Oxfam-Solidarité

Today, 29 September, Cecilia Malmström will be auditioned by the European Parliament (EP) to confirm if she is to become the European Commission’s (EC) new Trade Commissioner. This is a very timely moment for the release of a joint paper by Oxfam and Health Action International Europe (HAI) on the impact of European Union (EU) trade policies on access to medicines, both in Europe and far beyond.

Stakes are high for Ms. Maelstrom who will be leading the EC Directorate-General for Trade’s (DG-Trade) agenda for the next five years. This will include negotiating Free Trade Agreements (FTAs) with other countries on behalf of EU Members States. She will be especially in the spotlight over the negotiation of the controversial FTA between the EU and the US that will affect millions of people: the Transatlantic Trade and Investment Partnership (TTIP).

Profits before patients in TTIP?

Leaked documents clearly show that the TTIP is a huge threat to European public health systems, due to its clear favouring of pharmaceutical companies’ commercial interests. One objective of the Pharmaceutical lobby is patent harmonization based on US law. This would mean more patents and less generic competition, thus more monopolies and unaffordable medicines. Another item on Pharma’s negotiating wish list is a ‘voice’ in EU Member States’ pricing and reimbursement policies. Increased companies’ voice in medicine would challenge Member states’ ability to take measures, such as price control, to control expenditure on medicines. Moreover, the Pharma lobby is seeking to restrict public access to clinical trials data, undermining the EU’s recent efforts to foster transparency in this area[1].

One of the TTIP’s most controversial elements is the inclusion of an Investor-State Dispute Settlement (ISDS) mechanism. ISDS gives foreign investors the right to sue governments for compensation if laws, policies, court decisions or other actions interfere with expected profits from investments. Governments’ actions such as price control or patentability standards could be challenged in court. While it may seem extreme, this threat is far from hypothetical. Following the legitimate invalidation of two of its patents, the American pharmaceutical company Eli Lilly is suing Canada for 500 million Canadian dollars compensation under the North American Free Trade Agreement  ISDS provision.

More worryingly still, the impact of the TTIP will not stop at EU or US borders. The TTIP would set a new global standard for strict intellectual property (IP) protection around the world, which could be imposed on developing countries through other trade deals[2].

FTAs have regularly been used by DG-Trade to introduce strict investment and IP rules (so-called “TRIPS-plus” measures), which go beyond the internationally-agreed IP standards set by the World Trade Organization. Such standards promote the commercial interests of the pharmaceutical industry even at the expense of public health. (See the EC’s latest document on the pharmaceutical industry).

The EC’s brand new strategy on IP enforcement in third countries explicitly describes IP as a means to boost Research and Development (R&D) and economic growth in the EU, ignoring how IP can also hinder innovation and competition. The proposed measures to enhance the enforcement of IP rights include FTAs and the identification of “priority countries”, as per the notorious US Special 301 report[3]. The EU list includes India and Thailand, two countries which have sought to balance IP rules and public health needs. The list foresees possible financial sanctions for countries repeatedly “infringing” IP rights. Sanctions could include restricting third countries’ participation in, or funding from, specific EU-funded programmes.

The EU’s “black sheep” on IP in trade policies

India and Thailand have bitter experiences of the EC heavy-handed approach to IP rights. Negotiations for a FTA between the EC and India started in 2009 and are currently on hold. India’s progressive IP law only grants patents for ”real” innovation (i.e. it rejects patents on products too similar to an existing product). This has allowed the country’s vibrant generic pharmaceutical sector to play an important role in driving the prices of medicines down in developing countries. As “the pharmacy of the developing world”, India provides over 80 percent of the world’s generic anti-retroviral medicines to treat HIV/AIDS. The EC’s attempt to impose TRIPs-plus provisions in the EU-India FTA caused a great outcry throughout the world, thankfully forcing the EC to backtrack on some of the most controversial provisions.

Yet, despite the EC’s commitment to stop pushing for TRIPS-plus measures in subsequent FTAs, the FTA being negotiated with Thailand since March 2013 (also currently on hold due to the military coup) contained similar controversial provisions. Instead of supporting Thailand’s good track record of pro-public health policies and its use of TRIPs flexibilities[4] to improve access to medicines, the EC tried to stop Thailand’s use of these legal, internationally-agreed measures.

Negotiations with both countries will resume in the near future.

Are IP rights really promoting health-driven innovation?

DG Trade – aligned with the pharmaceutical industry- portrays IP as the panacea to boost investments in R&D, thus justifying the inclusion of TRIPs-plus provisions in FTAs. However, it is clear that the current R&D system, which relies heavily on the profits generated by expensive, unaffordable medicines to provide incentives for innovation, fails to meet public health needs.

The current Ebola crisis and the controversy surrounding wildly unaffordable new medicines to treat Hepatitis C, clearly illustrate the R&D crisis. No medicines or vaccines are currently available to deal with the Ebola virus due to the lack of a market incentive; Ebola only affects some of the world’s poorest countries, where no company could ever make a profit. In the meantime, the pharmaceutical company Gilead priced its new and highly-effective medicine to treat Hepatitis C (marketed as Sovaldi) at $84,000 for a 12-week course. Even the discounted price that Gilead offered to some countries is still too high to treat all patients[5].

This raises serious questions about a system based on monopoly that keeps effective medicines from reaching the people that need them. Clearly alternative R&D models which are geared to address health needs must urgently be explored.

Change is needed, now!

The coming five years represent an   important opportunity for the EU to lead on trade and R&D policies which meet health needs, and which don’t favour commercial interests over patients’ needs.

Oxfam and HAI Europe urge the future Trade Commissioner Cecilia Maelstrom, to resist the pharmaceutical lobby and to ensure trade policies are aligned with the EU’s development and (global) health objectives. To reach this aim, DG Trade should ensure better coherence and coordination of work with other DGs. The newly elected parliament must ensure that EU trade and R&D policies prioritise access to medicines for all citizens around the world.

More concretely, the EC should:

  • Stop including TRIPS-plus and investment protection measures in FTAs which jeopardise access to medicines for millions, including in its negotiations with the US, India and Thailand;
  • Support generic competition to allow broad access to medical products in Low- and Middle-Income countries; and
  • Support new models of innovation, both those under development at the World Health Organisation, and in its own programmes.

References


[1] For a detailed analysis, see: Commons Network, HAI et al. (2014) ‘The Trans Atlantic Trade and Investment Partnership (TTIP): A Civil Society response to the Big Pharma Wish list’, joint position paper, http://www.prescrire.org/Docu/DOCSEUROPE/20140324CivilSocietyResponseBigPharmaWishList_final.pdf

[2] C. Gerstetter, M. Mehling, A. Eberle and K. Salès (2013) ‘Legal implications of the EU-US trade and investment partnership (TTIP) for the Acquis Communautaire and the ENVI relevant sectors that could be addressed during negotiations’, EP Directorate General for Internal Policies, http://www.europarl.europa.eu/RegData/etudes/etudes/join/2013/507492/IPOL-ENVI_ET(2013)507492_EN.pdf

[3] See USTR website: http://www.ustr.gov/about-us/press-office/press-releases/2014/April/USTR-Releases-Annual-Special-301-Report-on-Intellectual-Property-Rights

[4] In 2001, the WTO ministerial conference adopted the Doha Declaration on TRIPS and Public Health. It affirms that the WTO rules on IP should not prevent countries from taking measures to protect public health.

Doha Ministerial Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/W/2, 14 November 2001, http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

[5] http://www.globalhealthcheck.org/?p=1630

 

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Ebola: Some thoughts from my time in Liberia By John Spray, ODI Fellow, Ministry of Commerce and Industry, Liberia.

 

A lot has been written about the Ebola crisis in West Africa in the last few weeks. Many excellent articles have highlighted the plight of those suffering with Ebola (Newsweek), and the people on the frontline trying to tackle the virus (Time) and the consequences on the affected countries as a whole (How we made it in Africa). However, the real tragedy is how an inherently preventable virus was able to spread like wildfire throughout West Africa and why public health facilities failed on such an enormous scale.

I first heard about Ebola in March 2013, four months after the first patient died of the virus in a small village in south-eastern Guinea, the first ever in West Africa.
With the death toll rising across the border in Guinea, discussions in Monrovia turned to the threat of it reaching the capital: “no previous outbreak has killed more than 300 people”, “it is easy to avoid just don’t go near sick people and you are safe”, and “the disease kills people so quickly it will die out before it reaches Monrovia”. The general message was “it is scary, but we can control it with basic public health.”

Despite these reassurances, everyday you check the news: how many infected? How many died? How many health clinics were beginning to shut due to healthcare workers leaving their posts? Despite the growing chaos, we in Monrovia continued to rationalize the situation. We knew things were getting worse but we didn’t act in time.

So when did it get “out of control”? Was it when MSF declared it to be so in June? Was it when the virus hit Conakry, Freetown and Monrovia, making control of the disease in crowded urban environment increasingly hard? Perhaps it was when the Liberian-American Ministry of Finance consultant died after flying to Lagos, inadvertently putting a planeload of passengers and Africa’s most populous country at risk.

Whenever it was, there is no question that we are now in the middle of an unprecedented crisis. Every day, I dread reading the news. The front page of every newspaper is full of articles discussing the bleak picture of Liberia’s largest slum quarantined like something out of a science fiction novel. I read about the almost complete collapse of the government’s health care facilities and the justifiable fear of the healthcare workers too scared to go to work. We hear terrifying stories of suspected cases being turned away from treatment centres because there is no space to treat them, and bodies left on the street for days without someone coming to pick them up. Most of all, I fear for the secondary threats should countries follow through on plans to impose economic embargoes on the country.

Already five airlines have stopped flying to Liberia through fear of the disease. Earlier reports that West African ports have refused entry to vessels which have docked in Liberia appear false, but raise an alarming prospect of the country cut off from essential imports. This is dangerous given that Liberia is completely dependent on imports with an import bill equal to 60 percent of GDP including two of the most important commodities, fuel and rice. Even without an economic blockade importers are worried.

Early reports suggest for the last four weeks the number of import certificates are down 30 percent from the previous year. Not to mention, the travel restrictions inside the country making movement of agricultural goods from farm to market next to impossible. These developments will raise the price of essential goods necessary for the Liberian economy to function and will harm the very poorest. They also raise the possibility of riots on the street and a return to the days of anarchy last seen during Liberia’s bloody civil war.

So how did this happen? The underlying causes of this outbreak are many and difficult and will be discussed for years to come. Fundamentally, they focus on the fragility of West African states and the failure of emergency planning to tackle the crisis when it was at a manageable level.
What can we do about it? Despite the fear, there are many brave West Africans and foreigners continuing to fight this disease. The Ministry of Health is working to open new treatment centres, MSF continues to fight the battle on the front line and are managing patient care alongside national governments. The World Bank has promised USD200million to fight the disease in West Africa. The African Development Bank has promised USD210million to build West African public health facilities. The World Food Program has begun the process of bringing in food to tackle the secondary crisis. NGOs on the ground, including Oxfam, have begun gearing up awareness campaigns to get the message out that Ebola is preventable. These things are vital to the immediate fight and the world needs to react, and react fast.

Once the immediate crisis is brought under control, we must consider measures to strengthen the state institutions especially the health service in order to effectively deal with health threats in the region.

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World Hepatitis Day: Celebration of a new cure or commiseration for those who can’t afford it?

It’s not very often that we hear of a new medicine that actually cures a serious disease. This year, World Hepatitis Day comes with the exciting news of sofosbuvir; the new hepatitis C medicine with a cure rate of over 90%. Sofosbuvir can be used on its own in the form of one pill per day for 12 weeks. Existing treatments rely on a combination of daily oral ribavirin and weekly Interferon injections for around 48 weeks. The effectiveness of these old medicines is far below 90%, and they also carry painful side-effects in addition to the hassle associated with weekly injections.

So a new cure is good news? Unfortunately there is a big catch. The medicine is not affordable, even in high income countries. At the current price US $1000 per pill, the US public purse may have to pay over US $300 billion if the 3 million infected people are to be treated[1]. For example, it would cost the state of Oregon $360 million to treat its infected population. This would deplete the $377 million that the Oregon Medicaid program spent on all prescription drugs for its 600,000 members in 2013[2]. US insurance companies are rationing treatment and are telling doctors not to offer the medicine for all the patients that need it – keeping it only for very specific cases.

The situation in Europe is not much better. The cost of a 12-week treatment is €50,000 (US$68,000). The French health minister warned that such a high cost would have a negative impact on the French social security system, and called on the EU to collectively negotiate a lower price for sofosbuvir[3].

If cost is a major problem in the wealthier countries, then the impact of treatment price in middle-income and low-income countries will be even more dire. The majority of hepatitis C infected people – 80% – live in these countries. Countries with an infection prevalence rate higher than 10% are: Egypt at 14%, Cameroon 13.8%, Burundi 11.3%, and Mongolia 10.7%[4].

Clearly, none of these countries can afford the current high price. Gilead has entered into a deal with the Egyptian government to provide a 12-week course of treatment at US $900 per patient for the public sector[5]. At 14% prevalence in a population of over 82 million people, the potential number of people living with hepatitis C in Egypt is around 11.5 million[6]. To treat even just 5 million patients would cost Egypt the equivalent of nearly two-thirds of its total health budget (US $4.5 billion out of the current total health budget of US$ 7.22 billion for 2014/15)[7]. This cost is in addition to other drugs – pegylated interferon and ribavirin – which are needed in combination with sofosbuvir to reach the 90% cure rate for genotype 4, which is the strain of hepatitis C prevalent in Egypt.

Yet the price does not have to be this high, as illustrated in two ways. Firstly, a study by researchers at Liverpool University looked at the total real cost of the active pharmaceutical ingredients and the cost of manufacturing of the new direct anti-viral medicines class, of which sofosbuvir is one. They estimated the cost of a 12-week course of treatment with the combination of sofosbuvir and daclatasvir as US $78 per person[8].

Secondly, evidence shows that the price of medicines is slashed by generic competition. HIV treatment is a case in point: in 2000, at the height of the public outcry campaign against high medicine prices, it was very difficult to persuade any government or donors to pay for treatment, and millions of people in poor countries were left to die. The price of triple therapy for HIV was US $10,000 per patient per year. That was clearly unaffordable to patients, governments, and donors at the time. Thanks to generic competition from Indian companies, the price dropped almost overnight to US $360 per patient per year or US $1 day. Continuation of competition has resulted in the current price of triple therapy for HIV of approximately US $100 per patient per year.

Now that Trade Related Aspects of Intellectual Property Rights (TRIPS) is implemented in almost all countries, including those with manufacturing capacity such as India, it is much harder to scale up generic competition. However, TRIPS includes some flexibilities, which countries can use to help lower prices. For example, India’s patent law has a clause on “pre-grant opposition”, which allows any interested groups to challenge a patent application before the patent is granted. Civil society organisations have used this clause for sofosbuvir and therefore currently, it does not have a patent in India (although the final decision is awaiting a court ruling).

Compulsory licensing is an important legal TRIPS tool for governments to ensure affordable prices of new medicines. Use of this tool in India decreased the price of sorafenib (Nexavar) for the treatment of liver and kidney cancer from over US $5,500 per month to US $175[9]. In 2008, Thailand issued compulsory licenses for 3 cancer medicines, leading to a big drop in prices. For example, the price of one tablet of 2.5 mg of letrozole was slashed from the original Novartis price of US $£7.35 to the generic price of US $0.19-0.22 – a price differential of 30 times[10].

Obviously pharmaceutical companies and rich countries who support them do not like any government using this legal TRIPS tool. When Thailand issued compulsory licenses for medicines to treat HIV, cardiovascular disease, and cancer, it came under tremendous pressure from the US and the EU to stop[11]. Last year there was pressure by US businesses and Congress for the US government to take actions against India over its intellectual property regime[12].

The fundamental problem is the system of intellectual property rules which allows big companies to hold a monopoly on the price of medicines, thus giving them the power to set high prices. Moreover, financing for research and development (R&D) is still dictated by commercial interests rather than public health needs all over the world. Pharmaceutical companies are ferociously lobbying for stricter and stricter intellectual property protections as the only way to stimulate R&D and to ensure they can maintain their monopoly to set prices.

The price of the new hepatitis C medicine has given more momentum to the rising global movement that is challenging the high prices of new effective medicines for diseases ranging from cancer to cystic fibrosis[13]. As long as the cost of R&D is linked to drug pricing, pharmaceutical companies will continue to price medicines to ensure maximum profit, even if it means decreased access for people who need it. This is a public health travesty. .

The un-affordability of the most effective medicine that can cure hepatitis C today highlights the critical need to de-link financing for R&D from the price of medicines, and for finding new ways to finance R&D so that effective medicines are available at an affordable price to all who need them.

References

[2]http://www.washingtonpost.com/blogs/wonkblog/wp/2014/07/24/the-drug-thats-forcing-

americas-most-important-and-uncomfortable-health-care-debate/

[4] Lavanchy D.( 2011) Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect.;17(2):107-15

[5]http://www.reuters.com/article/2014/03/21/hepatitis-egypt-gilead-sciences-idUSL2N0MI1ID20140321

[7] Forthcoming: New effective hepatitis C medicines must reach all patients. PLOS

 

 

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اليوم العالمي للالتهاب الكبدي: احتفاءً بعلاج جديد أو مواساة لمن لا يستطيع شراءه ؟

World Hepatitis Day: Celebration of a new cure or commiseration for those who can’t afford it?

مهجة كمال ي
Translated into Arabic by Nagy Kamal Yanni

قليلاً ما نسمع عن دواء جديد يشفي فعلا ًمن مرض خطير. لكن في هذا العام يأتي اليوم العالمي للالتهاب الكبدي مع الأخبار المثيرة عن دواء سوفوسبوفير الجديد لعلاج التهاب الكبد سي. ويحقق الدواء نسبةشفاء عالية-أكثر من 90٪ ويستخدم في شكل حبة واحدة يوميا لمدة 12 أسبوعا بدون حقن. متفوقاً عن العلاجات الحالية التي تعتمد على مزيج من ريبافيرين عن طريق الفم يوميا مع حقن الإنترفيرون أسبوعيا لنحو 48 أسبوعا. وفعالية هذه الأدوية القديمة أقل بكثير من 90٪، كما ان لها آثارا جانبية مؤلمة بالإضافة للمتاعب المرتبطة بالحقن أسبوعيا.

فهل يمثل هذا العلاج الجديد أخباراً سارة؟ للأسف هناك مشكلة كبيرة- فالدواء ليس في متناول الجميع، حتى في البلدان ذات الدخل المرتفع . فطبقاً للسعر الحالي -1000 دولار أمريكي للحبة الواحدة- قد تضطر الميزانية الأمريكية لدفع أكثر من 300 مليار دولار لعلاج كل المصابين والذي يقدر عددهم ب 3 ملايين شخص
. فعلى سبيل المثال، فإن ولاية اوريجون ستتكلف 360 مليون دولار لعلاج سكان الولاية المصابين بالمرض مما يستنزف برنامج الولاية الطبي (377 مليون دولار) والمخصص للصرف علي جميع الأدوية لحوالي 600 ألف مواطن أعضاء في برنامج الولاية لعام 2013 . ونظرا لغلو سعر سوفوسبوفير، فقد قررت بعض شركات التأمين الامريكية تقنين العلاج وأعطوا تعليمات لأطبائهم بألا يقدموا الدواء لجميع المرضى الذين في حاجة إليه – وأن يصفوا الدواء فقط لحالات محددة جدا.

أما الوضع في أوروبا فهو ليس أفضل منه في أمريكا، فتكلفة العلاج لمدة 12 أسبوعا هي 50 ألف يورو (حوالي 68 ألف دولار). حتي أن وزيرة الصحة الفرنسية حذرت من أن مثل هذه التكلفة العالية سيكون لها تأثيراً سلبياً على نظام الضمان الاجتماعي الفرنسي، ودعت الاتحاد الأوروبي للتفاوض بشكل جماعي للوصول لأقل الأسعار

وإذا كانت التكلفة هي مشكلة رئيسية في البلدان الأكثر ثراء، فإن تأثير ارتفاع سعر العلاج في البلدان المتوسطة الدخل والمنخفضة الدخل ستكون له عواقب وخيمه. حيث يعيش فيها غالبية المصابين بالتهاب الكبد سي – 80٪ من المصابين. والبلاد التي لديها معدل انتشار العدوى أعلى من 10٪ هي: مصر في 14٪، الكاميرون 13.8٪ ، بوروندي 11.3٪، ومنغوليا 10.7٪ .

وغني عن الذكر أن هذه الدول لا تستطيع تحمل الأسعار الحالية المغالي فيها. وقد دخلت شركة جلياد في مفاوضات مع الحكومة المصرية لتقديم كورس للعلاج مدته 12 أسبوعا بسعر900 دولار لكل مريض يتم علاجه في المستشفيات الحكومية . وإذا كانت نسبة الإصابة في مصر هي 14٪ من السكان البالغ عددهم أكثر من 82 مليون شخص، فإن العدد المحتمل للمصابين بالتهاب الكبد C في مصر قد يصل إلي 11.5 مليون شخص . وبهذا فإن علاج حتى 5 ملايين مريض فقط قد يكلف مصر ما يعادل تقريبا ثلثي ميزانية الصحة الإجمالية (4.5 مليار دولار أمريكي من إجمالي 7.22 مليار دولار أمريكي لعام 2014/2015) . وهذه التكلفة بالإضافة إلى نفقات الأدوية الأخرى (ريبافيرين وبجيلاتد انترفيرون) وهي التي يجب استخدامها مع السوفوسبوفير للوصول إلى نسبة شفاء 90٪ للنمط الجيني رقم 4، وهو نمط التهاب الكبد C المنتشر في مصر.

ومع ذلك فإنه ليس من المحتم أن يكون سعر الدواء بهذا الغلو وذلك لسببين. السبب الأول هو أن باحثون في جامعة ليفربول أجروا دراسة عن التكلفة الحقيقية لعدد من الأدوية الجديدة المضادة للفيروسات والتي تشمل سوفوسبوفير وقد تضمنت الدراسة بحث تكاليف المكونات الصيدلانية الفعالة للدواء وتكلفة تصنيع الأدوية. وقدرت الدراسة أن تكلفة دورة علاج مدتها 12 أسبوعا مع مزيج من السوفوسبوفير والدكلاتاسفير sofosbuvir وdaclatasvir هو 78 دولار أمريكي للشخص الواحد .

والسبب الثاني هو أن الأدلة تشير إلى أن أسعار الأدوية تنخفض بواسطة منافسة الأدوية الجنيسة . فقد كان ثمن علاج فيروس نقص المناعة البشرية في عام 2000 مرتفعاً جداً وذلك في ذروة حملة احتجاج شعبي ضد ارتفاع أسعار الدواء، وكان من الصعوبة بمكان إقناع أي حكومة أو جهة مانحة بدفع تكاليف العلاج، وبذلك تُرِك الملايين من الناس في البلدان الفقيرة للموت .فقد كان سعر العلاج الثلاثي لفيروس نقص المناعة البشرية حوالي 10 ألاف دولار أمريكي لكل مريض سنوياً. ومن الواضح أنه لا يمكن أن يتحمل المرضي ولا الحكومات، ولا الجهات المانحة في ذلك الوقت مثل هذه النفقات. ولكن بفضل منافسة الشركات الهندية بالأدوية الجنيسة، فقد انخفض سعر العلاج الثلاثي بين ليلة وضحاها إلى 360 دولار لكل مريض في السنة أي بمعدل دولار أمريكي يوميا. وقد أدى استمرار المنافسة إلي السعر الحالي للعلاج الثلاثي وهو حوالي 100 دولار لكل مريض سنويا.

وبعد تطبيق اتفاقية “الجوانب المتصلة بالتجارة من حقوق الملكية الفكرية (تربس)” في جميع البلدان تقريبا، بما في ذلك تلك التي لديها القدرة التصنيعية مثل الهند، فقد أصبحت منافسة الأدوية الجنيسة أكثر صعوبة. ومع ذلك، فإن اتفاقية التربس تتضمن بعض المرونة، والتي يمكن أن تستخدمها البلدان للمساعدة في خفض الأسعار. فعلى سبيل المثال، يحتوي قانون براءات الاختراع في الهند علي بند بشأن “المعارضة قبل منح براءة الاختراع”، والذي يسمح لأي مجموعة مهتمة بالطعن في طلب البراءة قبل منحها. وقد استخدمت منظمات المجتمع المدني هذا البند للطعن علي طلب براءة الاختراع لدواء سوبوسبوفير. وبالتالي فإنه حتي الآن لم تمنح الهند براءة الاختراع للدواء (وينتظر القرار النهائي حكم المحكمة).

ويمكن للحكومات استخدام مرونة الترخيص الإجباري -وهي أداة قانونية هامة في اتفاقية النتربس-وذلك لضمان أسعار معقولة من الأدوية الجديدة. وقد استخدمت الهند الترخيص الاجباري لدواء سورافينيب (نيكسافار) sorafenib (Nexavar) لعلاج سرطان الكبد والكلى فانخفض سعره من حوالي 5500 دولار أمريكي في الشهر إلى 175 $ في الشهر . وفي عام 2008، أصدرت تايلاند تراخيص إجبارية لثلاثة أدوية لعلاج السرطان، مما أدى إلى انخفاض كبير في الأسعار. فعلى سبيل المثال، تم تخفيض سعر القرص الواحد من عقارلتروزول letrozole 2.5 ملج من السعر الأصلي لشركة نوفارتيس وهو 7،35 دولار إلي من 0،19 الي 0،22 دولار- أي أقل 30 مرة من السعر الأصلي .

ومن الواضح أن شركات الأدوية والبلدان الغنية التي تدعمهم لا تفضل استخدام الحكومات لمثل هذه الأدوات القانونية الموجودة في اتفاقية التربس. فعندما أصدرت تايلاند التراخيص الإجبارية لأدوية علاج فيروس نقص المناعة البشرية وأمراض القلب والأوعية الدموية، والسرطان، فإنها وقعت تحت ضغط هائل من كلا من الولايات المتحدة والاتحاد الأوروبي حتي تتوقف عن استخدام الترخيص الإجباري . وفي العام الماضي كانت هناك ضغوط كبيرة من قبل الشركات الأميركية والكونجرس علي حكومة الولايات المتحدة لكي تتخذ إجراءات صارمة ضد الهند بسبب نظام الملكية الفكرية الهندي .

وتقع المشكلة الأساسية المؤدية لارتفاع أسعار الأدوية الجديدة في نظام قواعد الملكية الفكرية التي تتيح للشركات الكبيرة احتكار أسعار الأدوية، وبالتالي تمنحهم القدرة على التحكم فيها. وعلاوة على ذلك، فإن تمويل البحث والتطويرR&D) ) للأدوية لا تزال تمليها المصالح التجارية بدلا من الاحتياجات الصحية العامة في جميع أنحاء العالم. وتضغط شركات الأدوية بشراسة لحماية الملكية الفكرية ولجعلها أكثر صرامة باعتبارها السبيل الوحيد لتحفيز البحث والتطوير وللتأكد من أن هذه الشركات قادرة على المحافظة على احتكارها للتحكم في الأسعار.

وقد أعطى سعر الدواء الجديد التهاب الكبد سي المزيد من الزخم إلى الحركة العالمية المتصاعدة ضد ارتفاع أسعار الأدوية الجديدة الفعالة في مكافحة الأمراض ابتداء من السرطان إلى التليف الكيسي cystic fibrosis وطالما استمر ربط تكلفة البحث والتطوير بتسعير الأدوية، فسوف تستمر شركات الأدوية في تسعير الأدوية بما يحقق لها أقصى قدر من الأرباح، حتى لو كان ذلك يعني انخفاض إتاحة الأدوية للأشخاص الذين هم في حاجة إليها.
وتلك هي مهزلة الصحة العامة.

إن سعر الأدوية الأكثر فعالية والتي يمكنها علاج التهاب الكبد سي اليوم، يسلط الضوء على الحاجة الماسة للفصل بين تمويل البحث والتطوير وسياسات التسعير، وإلي الحاجه الماسة لإيجاد سبل جديدة لتمويل البحث والتطوير لإتاحة الأدوية الفعالة بأسعار في متناول جميع المحتاجين إليها.

المراجع

[1]http://www.bloomberg.com/news/2014-04-08/express-scripts-raises-pressure-on-gilead-for-drug-price.html

[2]http://www.washingtonpost.com/blogs/wonkblog/wp/2014/07/24/the-drug-thats-forcing-americas-most-important-and-uncomfortable-health-care-debate/

[3]http://news.yahoo.com/eu-nations-join-forces-against-exorbitant-hepatitis-c-193456820.html

[4]Lavanchy D.( 2011) Evolving epidemiology of hepatitis C virus.Clin Microbiol Infect.;17(2):107-15

[5]http://www.reuters.com/article/2014/03/21/hepatitis-egypt-gilead-sciences-idUSL2N0MI1ID20140321

[6]http://countryeconomy.com/demography/population/egypt

[7]Forthcoming: New effective hepatitis C medicines must reach all patients. PLOS

[8]http://cid.oxfordjournals.org/content/early/2014/01/06/cid.ciu012.full.pdf

[9]http://www.pharmatimes.com/article/13-03-05/Bayer_loses_appeal_in_Indian_compulsory_licence_case.aspx

[10]http://www.moph.go.th/hot/Second_white_paper_on_the_Thai_CL_%5bEN%5d.pdf

[11]http://www.wcl.american.edu/pijip/documents/mandelson07102007.pdf

[12]http://www.ip-watch.org/2013/06/20/170-members-of-us-congress-pressure-india-on-ip-rights/

[13]http://online.wsj.com/articles/costly-drug-vertex-is-denied-and-medicaid-patients-sue-1405564205

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Have pharmaceutical companies changed?

TAKE 1: CLACKET FIRST TIME OF PHARMA FILM

It is 1996 and the scene is starting with the plight of HIV hitting the news. By 2000, it was clear for all to see that the medicines available to treat this deadly disease are in the North while the disease is most prevalent in the poorer countries in the South. It was estimated that one in five South Africans was infected.

Yet 39 multinational pharmaceutical companies decided to take Nelson Mandela’s Government to court over an Intellectual Property Bill that tried to prevent patents from hindering access to medicines. Thanks to a global public campaign and patients’ advocacy, the companies were forced to withdraw their case in 2001.

Talk to “big pharma” and they will tell you that the South Africa court case was a landmark in their history. Some even say that such a thing would not happen again. One cannot help a cynical smile when remembering that in 2006 Novartis took the Indian government to court over the claim that India’s intellectual property law is not TRIPS  compliant. Needless to say Novartis lost its case. At least this time other companies watched from a distance without giving public support for Novartis.

TAKE 2: CLACKET SECOND TIME OF THE SAME FILM

It is 2014 and the scene is of a world waking up to the growing plight of non-communicable diseases. The latest WHO report estimates that cancer cases are expected to soar by 70% over the next 20 years . Although the big talk is still about prevention (which of course is critical), very few are talking about treatment. In the current debates on post MDGs cancer is hardly mentioned and in the discussions on Universal Health Coverage one rarely hears about how to make detection and treatment (surgery, radiotherapy and medicines) available and affordable. 

Roche markets a drug for cancer (Avastin) which was discovered to also cure a type of blindness affecting older people. So Roche patented another form of the drug (Lucentis) as specific treatment for the eye condition. The catch is that one injection of Avastin costs $50 while a Lucentis injection costs $2,000. Another example that recently hit the headlines is that of a new medicine to treat Hepatitis C (made by Gilead) but alas it costs $1,000 per day.

Needless to say that access to affordable medicines for HIV and other infections remains an “unfinished” agenda – the debate on medicine price is just as important today as it was in late nineties and early 2000s.

And now back to South Africa again. In February this year, a leaked document shows that the Innovative Pharmaceutical Industry Association of South Africa (IPASA) and its sister organisation in the US (PhRMA), hired a PR company to conduct a covert campaign against the South African government. The campaign intended to delay and undermine the Government’s new Intellectual Property Bill which seeks to use internationally agreed legal instruments such as the TRIPS flexibilities included in the Indian law, to enhance access to more affordable generic medicines in South Africa.

But the pharmaceutical industry does not want the South African government to take such actions to protect public health. IPASA made a submission to the DTI on the Draft National Policy on Intellectual Property in support of the current status quo.

The South African Department of Health condemned the recently leaked pharmaceutical industry strategy. The Minister of Health described the proposal as a “genocidal conspiracy of satanic magnitude”, accusing pharmaceutical companies of “conspiring against the state, the people of South Africa and the populations of developing countries” – and of planning what amounts to “mass murder”.

SO HAVE PHARMACEUTICAL COMPANIES CHANGED?

I cannot answer this question any better than the honest statement given by Marijn Dekkers, CEO of Bayer who said in reference to Bayer’s medicine Nexavar for the treatment of liver and kidney cancer: 

“ .. we did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product, quite honestly. It is an expensive product, being an oncology product.”

These simple words tell us the whole story of multinational pharmaceutical companies’ approach to access to medicines: that they are about maximizing profits and not about contributing to advancing public health. All their talk of “putting patients at the front of our business” is just talk for public consumption to improve their PR image. The business model of multinational pharmaceutical companies – founded on maximizing profit – dictates the Research & Development agenda and the pricing and marketing pathways. Companies still refer to compulsory license, a legal instrument under TRIPS, as “essentially theft.”

We must always remember that it was this industry –chiefly Pfizer- which lobbied and succeeded in designing a global Intellectual Property system (TRIPS) and fought hard against the flexibilities and instrument included there for countries to use to protect their citizens.   It is pharma that continues to lobby for stricter Intellectual Property rules in free trade agreements that further tie the hands of governments so that companies’ monopoly is extended.

So what has changed apart from adopting new tactics? Well at least some companies remembered – and perhaps did not want to repeat – the old South Africa saga and started to withdraw from the IPASA campaign plan. The Danish company, Novo Nordisk dissociated itself from IPASA and more recently Roche followed suit.

The big question remains though: when will multinational pharmaceutical companies realise the failure of their Intellectual Property-dependent business model and seek alternatives?

Dr Mohga Kamal-Yanni is a Senior Health Policy Advisor at Oxfam GB

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Global Health Check is edited by Anna Marriott, Health Policy Advisor for Oxfam GB, and welcomes contributions from different authors. If you would like to write an article for this site or if you have any queries please contact: amarriott@oxfam.org.uk.