Patients must set the agenda on non-communicable diseases

The International Alliance of Patient Organizations (IAPO) yesterday held a side meeting at the World Health Assembly in Geneva in regards to the role of patients in preventing and managing non-communicable diseases.  The press release from this event is attached below.  More updates from the World Health Assembly can be followed on twitter via #worldhealthassembly, #NCDs or #globalhealth — or for updates of interest follow @whonews, @globalhealth, @whadvocacy or @NCDAlliance.

Patients must set the agenda on non-communicable diseases

Geneva, Switzerland, 17 May 2011 – Patient advocates have called for a stronger role in setting the agenda in the design and delivery of strategies to prevent and manage non-communicable diseases (NCDs), and chronic diseases more broadly. This call was made at a Side Meeting to the World Health Organization (WHO) World Health Assembly in Geneva, Switzerland. The meeting was hosted by the International Alliance of Patients’ Organizations (IAPO) and two of its member patient groups; Alzheimer’s Disease International (ADI) and the Multiple Sclerosis International Federation (MSIF) and attended by over 50 participants including member state representatives, health professionals and WHO representatives.

Speakers from Africa, Latin America and Europe highlighted, with practical examples, how patient advocates are contributing knowledge, experience and resources to support efforts to tackle chronic disease. Across the world in high, middle and low income countries, patient groups routinely provide health information and training to patients and health professionals. These have been shown to support prevention strategies and effective disease management to ensure that patients’ needs are met. Interventions like these and many others are driven from within the communities they serve, reflecting their needs and preferences and ensuring that they are relevant to the context in which they are being implemented. For these to be most effective there needs to be a greater focus on, and commitment to, policy-making that involves the users of care. As the United Nations High-level Meeting on Non-communicable Diseases approaches, it is vital that discussions and outcomes reflect the fundamental changes that are needed to strengthen and adapt healthcare systems to involve and address the health and quality of life needs of patients with chronic disease.

Patient advocates stressed a need for a greater focus on disease management, including reducing severity and promoting quality of life, in addition to prevention. They called a greater role for patients’ organizations in every stage of NCD policy and program design along with implementation at all levels. It was also stressed that it was important that the work undertaken to address NCDs strengthens health systems ability to respond to all chronic conditions.

A participant, Jose M. Martin-Moreno, Director, Programme Management of WHO Regional Office for Europe said ‘Policy-making in health matters should involve the patient voice for the benefit of all. Within health systems we should not compete but ensure that we prevent the preventable, diagnose early, take care of those with a disease and give dignity to those at the end of life. Patients have an important role to play in achieving these goals.’

Brazil expands access to cancer treatments

Under a massive expansion of its oncology services, Brazil’s national health care system (SUS) will offer cancer patients access to nine new treatments and expand coverage for 66 already-covered procedures, including 46 chemotherapy treatments.  (source:  PharmaTimes)

The nine treatments which are to be made available for the first time through the SUS include three for liver cancer plus five for breast cancer, leukemia and lymphoma and one new radiotherapy treatment.

Investments in the SUS oncology services, which provide treatment for around 300,000 cancer patients, will increase 25% to 412.7 million reals this year, rising to 2 billion reals in 2011. The widening of value coverage for already-provided treatments will see investments in chemotherapy services increasing from 1.25 billion reals last year to 1.5 billion in 2011, with particularly large increases in spending on treatments for conditions such as chronic lymphocytic leukemia, set to rise 765%.

Cancer is Brazil’s second-biggest killer after cardiovascular disease, and the fact that the SUS guarantees virtually all diagnosed patients have access to treatment makes it an attractive market for drugmakers. For example, last year the country’s breast cancer drug market was worth  $424 million, rivaling some major markets such as the UK and Japan and greatly exceeding the other BRIC (Russia, India and China) nations, says market research firm Decision Resources, which forecasts that breast cancer drug sales in Brazil will rise to $611 million by 2014.

The analysts forecast that the SUS oncology services will continue to give priority to the introduction of new technologies, and that the government will maintain its support for local production facilities, such as the development, in partnership with Argentina, of two reactors for the production of oncology drugs, announced in June.

Decision Resources is also forecasting good growth for Brazil’s non-small-cell lung (NSCL) cancer drug market, driven by increased uptake of higher-priced brands of chemotherapy, around 21% annual growth for targeted regimens and maintenance treatment (all in the advanced setting) and modest uptake of novel targeted agents. Drugs produced by western manufacturers will increase their share of the market from around 60% last year to 70% in 2014, when the total NSCL cancer drug market will be worth $240 million, it says.

- With annual drug sales of just over $17 billion, Brazil is the world’s 11^th-largest pharmaceutical market and is once again the biggest in Latin America. Having fallen behind Mexico in the earlier part of the decade, it has produced consistent double-digit growth in the last five years, reaching a peak of 33% in 2005 and rising 13% in 2009, reports IMS Health.

Cutting drug prices hampers innovation: study

Cutting pharmaceutical prices in the way European governments are doing now will severely reduce the number of new drugs making it to market.  There is a direct link between strict regulation and low innovation in the sector, according to a study by a Berlin-based European School of Management and Technology Competition Analysis (EMST CA) and commissioned by the drugmaker Novartis (download a PDF of the full study).

The EMST report said that while European governments predominantly see pharmaceutical pricing models as a way of controlling public health costs, they may not realize or acknowledge the implications for product value, and therefore for the development of new drugs.

The report goes on to argue that current pricing models “are often shown to favor ‘breakthrough’ pharmaceutical innovations over ‘follow-on’ drugs, or incremental improvements”.  This can lead to ‘a different understanding of innovation for patients and chemists’, the study states.

For example, a statin may be redeveloped to have fewer side effects or be more beneficial for one group of patients and while this will seem like an innovative development to the patient, “it will not necessarily be innovative enough from the pricing regulator’s point of view to benefit from favorable regulation”.

The report concludes by saying that the analysis “demonstrates the need to support both ‘first in class’ and ‘best in class’ products, rather than drawing a regulatory distinction between ‘breakthrough’ products and everything else”.

New research unit boosts hope for patients with rare diseases

On Monday, Pfizer announced the creation of a new research unit which will specifically focus on the treatment of orphan diseases — those that affect fewer than 200,000 patients worldwide.

Of the more than 6000 diseases classified as orphan diseases, fewer than ten percent have therapies that directly address the underlying disease.  Pfizer stated that they intend to work closely with patient advocacy groups as it develops and advances the unit’s research strategy.

The new unit got the thumbs-up from National Organization for Rare Disorders in the USA. Its chief executive, Peter Saltonstall, noted that “30 million Americans, 30 million Europeans and millions more around the world have rare diseases” and applauded the development of new treatments “for this medically-underserved population.”

Health, Safety and IP – a public consultation

The newly appointed Intellectual Property Enforcement Coordinator in the U.S. has recently initiated a public consultation on the health-related costs and risks of intellectual property infringement.  The consultation (open to individuals, patient groups, NGOs, academics and other interested parties) is asking for comments on:

- safety issues resulting from IP infringement (such as counterfeit and/or sub-standard medicines)

- economic costs of IP infringement (research that shows intellectual property accounts for 20 percent of U.S. gross domestic product (GDP) and nearly 40 percent of U.S. economic growth).

Deadline: Submissions must be received on or before Wednesday, March 24, 2010, at 5 p.m.

How to submit: Submissions should be sent electronically to intellectualproperty@omb.eop.gov.

More information on the consultation (PDF)

Patients’ Manifesto launched in European Parliament

The European Patient Forum (EPF) launched a patients’ manifesto (or bill or rights) in the European Parliament yesterday.  The following press release from the EPF outlines their call to action for the empowerment and protection of patients across Europe:

(Sept. 16, 2008)  The European Patients’ Forum launched today a Patients Manifesto in the European Parliament outlining vital new measures in three fundamental areas to improve quality of healthcare across the European Union. EPF calls for

• Equal and timely access to safe, effective diagnosis, treatments and support;
• Better information and resources for patients to be partners in determining their care; and
• A patients’ voice to be heard in Brussels and throughout the European Union.

The lead-up to the forthcoming European Parliamentary Elections and new Commission is a time to set new political priorities, and commit to take action.

EPF President Anders Olauson said “Our current health systems can be unfair, divisive and fail to put the patients‟ perspective first. We believe all patients within the EU have a basic right to equal access to quality medical treatment, regardless of where they live, their status or their income.

The Manifesto, developed by the EPF membership, who collectively represent over 150 million patients, citizens and voters ‘call upon all the political groups within the European Parliament, MEPs, prospective MEPs, national representatives in EU Member States, and the new Commission, to commit to the legitimate rights and needs of patients and to make our proposals their priority’.

Dagmar Roth Behrendt, MEP who hosted the launch in the European Parliament welcomed the Manifesto “This Manifesto – from patients themselves – provides a road map for all of us committed to improving healthcare in Europe. I am especially pleased to see the Manifesto calls for a comprehensive strategy on “Information to Patients” in Europe and pro-active work on health literacy – this is a crucial driver behind patients‟ centred, quality healthcare.

What was the final outcome of the IGWG anyway?

After all the talk, all the negotiations late into the night, all the lobbying and the mud slinging, what actually happened to the IGWG at the end of the 61st World Health Assembly – and what does it mean for patients around the world? 

According to the WHO web site, the “Global Strategy on public health, innovation and intellectual property endorsed by the 61st World Health Assembly is designed to promote new approaches to pharmaceutical R&D and to improve access to medicines. It also provides a framework for enhancing and making sustainable essential R&D relevant to diseases impacting developing countries”.

So… what does that mean? What final document was tabled, and what areas are still under debate?

According to the WHO web site:

• The Global strategy was approved by the World Health Assembly; 
• The plan of action was also approved, except for 9 actions, which remain “open”; 
• In the short term, the WHO will prepare a ‘quick start’ programme and will begin to immediately implement the elements of the global strategy that fall under its responsibility;
• The WHO will finalize the outstanding components to the plan of action;
• The WHO will estimate the cost implications of the plan;
• The WHO will establish (yet another) expert working group to examine current financing and coordination of R&D, as well as proposals for new and innovative sources of funding to stimulate R&D.

The implications of this strategy for patients around the world remain to be seen.  What is clear, is the important role that patients around the world should be playing in these discussions on global innovation and access to medicines.  In an ideal situation, the WHO will acknowledge patients as the key stakeholder in global health and invite patients and their advocates to join the discussion.  Until that happens, patients and patient advocates should take every opportunity to engage their regional representatives, WHO officials and each other in this important dialogue.

New Government in Thailand Supports the Role of Medical Innovation in Improving Patient Outcomes

A recent editorial in the Wall Street Journal Asia (Good Medicine for Thailand) commends recent efforts on behalf of the Thai government to improve support for drug research and development and highlights the importance of medical innovation in improving health care delivery and patient outcomes.

It appears the new government in Thailand is starting to recognize that encouraging innovation, and developing better drug pricing and delivery schemes is in the best interests of Thai patients.

Last week the government removed one of the most vocal opponents of intellectual property rights from the board of the state-owned Government Pharmaceutical Organization.  It’s a small step, but an important one for restoring Thailand’s international reputation and protecting patients’ health.

Vichai Chokeviva argued that Bangkok was acting according to domestic and international law when it allowed the government to manufacture HIV/AIDS and cancer drugs using formulas patented by Sanofi-Aventis, Abbott Laboratories and other companies.

That’s debateable, at best. The World Trade Organization says patents can be seized – after negotiation – in cases of “national emergency” or for “public non-commercial use.”  But Thailand doesn’t have an HIV/AIDS epidemic like sub-Saharan Africa, and its cancer incidence rates are average.  As for the “non-commercial use” clause, Mr. Vichai opposed the appointment of the president of Thailand’s Pharmaceutical Research and Manufacturers Association to the GPO board last month because “the private sector” is “our business competitor [our emphasis].”  Thailand also didn’t do much to negotiate with the drug companies before seizing their inventions.

Health Minister Chaiya Sasomsup, who took office in February, deserves kudos for removing the official sanction for these kinds of harmful public voices.

Mr. Chaiya understands that drug companies won’t devote significant resources to researching Thai-specific diseases if they aren’t compensated for their innovations. The Government Pharmaceutical Organization has a history of corruption and isn’t certified by the World Health Organization. It is hardly an institution to invest with more power.

Far better to encourage world-class, private drug companies to invest in Thailand and work with the government on better drug pricing schemes and delivery programs. Mr. Chaiya’s quiet war for property rights isn’t on behalf of the drug companies. It’s in the best interest of Thai patients.

Report on the IGWG

The World Health Organization recently posted a news release stating that:

the <World> Health Assembly produced a public health breakthrough by providing a platform for removing barriers and using innovative methods to encourage research, development and access to medicines for the common diseases of the developing world.

The public health, innovation and intellectual property strategy endorsed by the Health Assembly is designed to promote new approaches to pharmaceutical research and development (R&D), and to enhance access to medicines. It is also designed to provide a medium-term framework for enhancing and making sustainable essential R&D relevant to diseases impacting developing countries.

According to the WHO’s report on the IGWG, Member States agreed to encourage the application and management of intellectual property in a way that maximizes health-related innovation and access.  Other components of the strategy, endorsed by the Member States include:

• An assessment of health needs in developing countries and identification of research and development priorities;
• Promotion of research and development on diseases which substantially or overwhelmingly affect people in developing countries, and also diseases which affect rich and poor countries with large numbers of vulnerable populations in both; 
• Exploration and implementation, where appropriate, of possible incentive schemes for research and development; 
• Improvement of research and development capacity in developing countries; 
• Improvement, promotion and acceleration of technology transfer; 
• Improvement of access to all health commodities by effectively overcoming barriers to access; and 
• Sustainable financing for R&D in developing countries.

The short-term follow-up actions from the World Health Assembly are for the WHO to:

• Prepare a quick start programme with adequate budget provision and begin immediately to implement the elements of the global strategy that fall under its responsibility;
• Finalize the outstanding components of the plan of action and estimate the cost implications of the plan; and
• Establish an expert working group to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development.

What does this outcome mean for patients around the world? 

At this point, the answer to that question remains unclear as the discussion on financing and strategic implementation will continue over the next year at least.  Hopefully, the WHO will engage patients in these discussions.

Resolution on counterfeit medicine

On May 20th a draft resolution on counterfeit medical products was submitted to the World Health Assembly by the nations of Gambia, Ghana, Nigeria, Tunisia and the United Arab Emirates.  As the WHA turns to the challenges surrounding counterfeit pharmaceuticals, it is valuable to reflect on the threat counterfeit drugs pose.  In particular, it is important to address the dangerous claim that “counterfeits may at times have advantages . . . (and) may even protect patients”.  This argument has been presented by BUKO Pharma-Kampagne, a member of Health Action International. [1]

This paradoxical assertion is based on the mistaken reasoning that consumers who received counterfeit versions of risky drugs (e.g. Novalgin [active ingredient: dipyrone]) are better off with the spurious fakes than with the genuine drug.  This claim rests on the flawed assumption that the counterfeits themselves are not dangerous.  Although they may not be harmful, it may be the case that they are lethal.  Consider the parallels with collecting wild mushrooms in the woods.  It may be that the mushrooms collected are wonderful or they may be Death Caps.  The gamble patients take with counterfeit drugs is no different.   Given this, it is irresponsible to suggest that counterfeits may protect patients.  In the case of the genuine medicine, it is a known entity with known risks.  In the case of a counterfeit, the dangers are unknown and the chemical composition uncertain. 

Put simply, counterfeit drugs are always dangerous.  Their contents, production and handling are unregulated and of indeterminate quality and safety.  By definition counterfeits engender uncertainty and unknown risk.  In 1992 the WHO defined a counterfeit as:

“…one which is deliberately and fraudulently mislabeled with respect to identity and/or source.  Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, wrong ingredients, without active ingredients, with incorrect quantity of active ingredient or with fake packaging.” [2]

As the World Health Assembly sets about addressing the threat of counterfeit medicines they must acknowledge, in no uncertain terms, that counterfeits are always dangerous for consumers and detrimental to public health.  To do otherwise would undermine the pursuit of health for all and the regulatory regimes that guarantee the safety and quality of today’s medicines.  Counterfeit medicines are never an acceptable substitute for genuine medicines and should never be considered beneficial or as a solution to high drug prices for developing nations.  The risk is unacceptable for even the most vulnerable populations.  Everyone, including the poor, is entitled to high quality medicines.   To argue otherwise is dishonest and an injustice to patients.

[1] BUKO Pharma-Kampagne.  “Counterfeit Medicines – What Are the Problems?” PHARMA-Brief Special, Special Nr.1, 2007, pg.3. 
[2] World Health Organization.  Counterfeit Drugs:  Report of a WHO/IFPMA Workshop. WHO/DMP/CFD/92, Geneva:  World Health Organization, 1-3 April 1992.