The search for a sustainable, affordable and complaint access strategy is a tough task but the gains outweigh the pains By Viveka Roychowdhury
There is no doubt that the pharmaceutical industry has a social commitment to public health. Many pharma companies do take this commitment seriously enough to invest considerable resources to reduce disease burden by increasing access to doctors, diagnostics, medication and a host of interventions. Their access strategies most often take the form of patient outreach programmes and health awareness campaigns through which they identify a health need and try to address gaps in current healthcare systems. Pharma companies have been part of global and national campaigns aimed at achieving public health goals, be it eradicating infectious diseases like polio, TB or HIV, or managing NCDs like diabetes.
But how effective are such interventions? Can they be replicated? Are they sustainable? And above all, are they above the needle of suspicion that they are but a means to access and penetrate new markets?
Since 2008, the Netherlands-based Access to Medicine Foundation’s Access to Medicine Index has evolved into a barometer of effectiveness of these access programmes, at least for the 20 research-based pharma companies tracked by the Index. The Index analyses these companies on how they make medicines, vaccines and diagnostics more accessible in low- and middle-income countries. It also highlights best and innovative practices, and areas where progress has been made and where action is still required. Published every two years, the latest report released in December 2016 received financial support from the UK Government, the Bill & Melinda Gates Foundation and the Dutch Ministry of Foreign Affairs.
GSK leads the 2016 Index, for the fifth time, ahead of Johnson & Johnson (which improved its ranking by one place), Novartis (also up one rank) and Merck (up two places). Companies which showed maximum improvement in their rankings were AstraZeneca (up eight places from 15 to 7) and Takeda Pharmaceutical (up five places from 20 to 15). Novo Nordisk slipped eight places from second to 10th rank while Roche slipped seven places from 12 to 19.
But many would consider GSK’s top rank ironic since the company was pulled up by the Chinese government for ethical breaches. In fact, many big names in the pharma firmament have faulted on the ethics side. Which is probably why for the first time, the 2016 edition of the Index analysed pharma companies’ compliance performances alongside their systems and strategies for improving access to medicine.
Jayasree K Iyer, Executive Director, Access to Medicine Foundation acknowledges this “central tension” saying, “The social contract that companies have with the people is that the companies have the responsibility to provide quality, affordable and effective health products to people, who are ultimately their customers. However, there is a central tension between shareholder profits and stakeholder needs, exacerbated by poverty, inequality, and such.”
Explaining the methodology followed by the ranking she says, “The Index is built on a series of indicators; a company like GSK has done badly in the ethics section because of their breach in a country like China. They still top the Index even though they lost points here as they have shown the most engagement in poverty related R&D, and prove that they ensure the most number of products that are affordable (compared to the rest of the industry evaluated) and have shown a host of other programmes that they get credit for (licensing, capacity building, etc.).”
The Index also notes that companies are taking steps to address the compliance issues, “as they see misconduct as risky for their reputation and for their sales and for growth,” says Iyer.
Citing examples from the Index, she mentions how GSK and now six other companies (such as AstraZeneca, and Merck) are implementing incentives for their sales agents that are not related to sales targets. Instead, they reward other qualities, such as technical knowledge and level of service. Another example is Gilead (which slipped three ranks from 5 to 8), which has created a Pocket Guide to Regional Business that they use to manage compliance issues. “Keeping high standards and incentivising good ethical behaviour is critical, and must be upheld even when working in less regulated markets,” is Iyer’s firm recommendation.
Another highly rated criteria for the Index is engagement in R&D for new products even where there is a limited or no paying market. Here too, six companies (GSK, AbbVie, J&J, Sanofi, Novartis and Merck) account for nearly 75 per cent of projects targeting high-priority, low-incentive gaps identified by the Index, points out Iyer.
Balancing availability and accessibility
Ensuring both availability – the sufficient supply and appropriate quantity of resources, medicines and doctors for example – and accessibility – the equitable distribution of these resources – is a tough task. Global pharma companies run their access programmes across geographies, and each country comes with its own set of challenges.
Lokesh Sharma, Head, Public Health (Africa, Middle East, South Asia), QuintilesIMS agrees that the pharma sector recognises the challenges in the public health space and has put in effort in filling the gaps, by making healthcare and medicine accessible for public health. However, as he points out, “In India’s case, the pharma industry is still not self-reliant as most bulk drugs and Active Pharmaceutical Ingredients (APIs) are imported from China. Spurred by concerns about the pharma industry’s dependence on China, the government is said to be making efforts for the revival of the API industry to lessen dependency on import of key starting materials, intermediates and bulk drugs including from China. The challenge is to ensure that raw material is available here. So if public health needs to be strengthened, availability of medicines needs to be strengthened. The public health sector, at times, struggles to buy medicines which are not available in the open market.”
Highlighting another pain point, he says, “The pricing policy is another challenge for the industry impacting pharma and public health sectors. There is a need to have a robust and balanced pricing policy as well, which is uniform in nature and allows the public health sector to improve.” As Sharma sums up, “We still have a long way to go, both on the availability as well as the accessibility aspect.”
Giving a third perspective, from the academia and health research side, Dr C Ramesh, Dean School of Pharmaceutical Management, IIHMR University calls for collaborative work between pharma companies, hospitals and academia, in order to bring about future remedies and management of health care system in a modern way. “A product of amalgamation of all these three pillars of healthcare would give the future remedy of the health problem of our country.”
Jawed Zia, Country President, Novartis India too highlights the role of governments and different stakeholders, saying, “There is no single stakeholder who can achieve any of the Sustainable Development Goals (SDGs) in isolation. Education and health are closely interlinked. With education comes more health awareness and the desire to achieve health goals. Therefore it is up to not just the pharma companies but also the countries to step forward and look at various ways in which they together with other stakeholders come together to achieve various SDGs including those pertaining to health.”
Selective access?
But access programmes do have their critics. For instance, some pharma companies have come in for criticism as they keep key Middle Income Countries (MICs) out from their licensing agreements for key medicines. This is contradictory because the stated rationale of these agreements is to increase access. MICs tend to have a high burden of these diseases and the incidence is generally higher in poorer sections of all countries. As a result, this segment of population in MICs is doubly disadvantaged.
As Iyer emphasises, “There is clearly lots to do for pharma and for country governments.” For example, she points out that many MICs such as Brazil, China and Mexico are not covered by any licensing agreement for HIV/AIDS medicines while they are home to more than 1.8 million people living with HIV/AIDS. In the case of Hepatitis C, countries like Armenia, Brazil, China, Colombia, Mexico, Moldova, Kosovo, Peru, Tajikistan, Thailand and Ukraine are not covered by Hep C licenses though they are home to 22.4 million people living with hepatitis.
Here too, Iyer cites a few good examples mentioned in the Index, like Novartis’ social business Arogya Parivar (healthy family) programme in rural India and the various licenses that have included countries like India (for e.g. GSK’s Dolutagravir license, which includes India, permits licensees (generic medicine manufacturers) also the ability to supply product outside territories until patent expiry, which is a very important term to improve access worldwide).
Specific to India, GSK has identified elimination of lymphatic filariasis (LF) as the lead CSR project in India. Giving a snapshot of the impact of the project, A Vaidheesh, MD, GSK Pharmaceuticals says, “The LF project started in 2000. Over the past 15 years, we have donated more than five billion albendazole tablets across 70 countries, of which over 2.3 billion tablets have been donated in India to help eliminate LF. We have reached over 600 million people – including 200 million children. Researchers estimate the number of people at risk of infection of LF has almost halved since 2000. But the work does not stop here. We have pledged to donate albendazole to the WHO until LF has been eliminated as a public health problem.”
From idea to action
But the global pharma industry is much wider than the 20 companies tracked by the Index so of what use will this Index be to them? Iyer refers to the Access to Medicines Index report as a “book of ideas” as the “best practices that we illustrate help other companies to think about more effective and impactful ways to contribute, and helps governments to become better at negotiating what they need for their people, and prioritising access to medicine.”
For instance, several company programmes run in low and middle income countries that ensure that affordable products, and capacity building and infrastructure development go hand in hand when operating in low and middle income countries. In the 2016 Index, Iyer says they identified 57 best and innovative practices, ranging from examples that address affordability of non – communicable disease products such as the Novartis Access programme, affordability and availability of hypertension treatments such as AstraZeneca’s Healthy Heart Africa programme (both examples running in Africa) and improving overall health, treatments and control such as Eli Lilly’s activities in building local capacity to improve TB treatment and control in India.
And it won’t be long before the Foundation turns its lens on other sections of the pharma industry. While the Index has so far focussed on the research-based industry, spanning MNCs, there are plans to create a similar index for the generics industry and indigenous companies. “The generics industry is important to engage in access to medicine, as is tracking progress towards goals there. We are still raising funds to launch this project,” says Iyer.
“We have spent the last 10 years evaluating big pharma, and we would love to have the opportunity to seek a (multistakeholder) consensus on what the indigenous industry can do more for people and then track progress towards those goals. I’m sure that there are significant programmes in place also for indigenous companies, and by showing what works and why, it becomes a book of more ideas that companies can learn from as they innovate, address the needs of local people, ensure that products are reaching those regardless of demographic, environmental, literacy or even “ruralness” of communities,” explains Iyer.
No one size fits all model
The industry will have to evolve its access strategies, country by country, and in some cases, state by state. As Zia of Novartis puts it, “Health needs and challenges vary greatly from place to place and also within a country the size of India. There is no one size fits all model which is why we follow a mix of approaches that drive access to modern medicine with various novel products launched at prices that are relevant for the Indian setting. Among the various approaches we have full donation programmes through partner organisations including WHO for leprosy drugs and The Max Foundation that administers the full donation Glivec programme for CML and GIST, co-pay programmes for various disease areas where the patient buys x days/ weeks of therapy and the balance is free and at cost programmes.”
Explaining the company’s access strategy for India, Zia says, “Since healthcare is a state subject in India, we endeavour to identify gaps in key states and work with local officials and stakeholders to build capacity of healthcare workers and increase awareness among patients. We have forged partnerships in some states to advance diagnosis of chronic diseases such as diabetes and cardio-vascular diseases.”
In a similar vein, the strategy to enhance access in rural India is that Novartis recruits and trains locals in remote villages to become “health educators,” who help inform communities about health, disease prevention and the benefits of seeking timely treatment in the local language. Local teams work with doctors to organise health camps in remote villages – mobile clinics that provide access to screening, diagnosis and therapies. Arogya Parivar is today present in 11 states.
Ventures like Novartis’ Arogya Parivar fill a very crucial gap in India’s healthcare delivery infrastructure, the urban-rural divide. “The healthcare services in India are skewed in favour of urban areas. Rural India suffers from a lack of health infrastructure and trained healthcare providers including doctors, nurses and diagnostic centres. Arogya Parivar makes a consistent effort in bringing healthcare to the village level for the rural population through customised training of the rural youth to provide health awareness and aid patient empowerment. Arogya Parivar has a direct distribution network in Tier IV and V cities helping build the infrastructure to launch affordable products for rural India.”
Health awareness can empower people in rural areas to seek quality healthcare and early detection of disease and together with a focus on compliance, this helps bring accountability on the healthcare providers, points out Zia.
Likewise, GSK India has partnered with two NGOs, ARTH and CARE, to address the entire continuum of care for newborn survival in the high burden districts in Rajasthan and Madhya Pradesh. The impact of this project can be judged from the numbers. According to Vaidheesh, 82 per cent of neonates have been saved. 70 per cent of sick children are assessed by ASHAs, who refer sick children to the facilities. Female sick newborns are especially tracked for danger signs. Trained ASHA facilitators pay visits at least once a month for all ASHAs. 70 per cent birth attendants are able to demonstrate NSSK skills while 80 per cent ASHAs have HBNC knowledge and skills, he says, citing the latest figures, which points to a gradual up skilling of this key link in the health delivery network.
Harking back to Iyer’s intention to engage with indigenous pharma companies and track their role in access, many Indian companies have access programmes similar to those of MNCs. For instance, take Glenmark’s Project Kavach.
Giving the rationale behind their flagship CSR programme, Cheryl Pinto, Director, Corporate Affairs, Glenmark says, “A few years ago, we conducted a detailed research in the field of child health and the key findings of the research directed us to initiate Project ‘Kavach’… the word ‘Kavach’ means a shield and symbolises protection. The aim of ‘Project Kavach’ is to reduce infant and child mortality in children between zero to five years.”
Project Kavach was initiated in 2011, and provides ambulatory care to the remotest forest-based villages which do not have accessibility to proper health care. According to Pinto, it runs five days a week to attend to the children with Severe Acute Malnourishment (SAM) condition who are identified and referred to the nutritional rehabilitation centre. “Over the years, we have been able positively impact 6,18,617 lives; 1,22,324 children were reached out through nutrition, immunisation and sanitation interventions; 26,608 malnourished children were treated; healthcare support were provided to 62,981 pregnant and lactating women; and 12,514 children were successfully immunised.”
The way ahead
Sharma of QuintilesIMS feels that one solution (to plug gaps in current access programs and improve impact) could be better management of information. “There is no pharma monitoring information system (PMIS) which can give a complete holistic picture of what is happening in the pharma industry right from research to pharmacovigilance. At present, the information is scattered. The pharma industry and the government need to come together in establishing a PMIS for timely information which would play a critical role in monitoring the operations at the grassroots, help in informed decision making, and thus allocating adequate resources for the same.”
Governments need to find ways to incentivise access to make it more sustainable for corporates to commit resources on a long-term basis. Once again stressing the collaborative approach, Ramesh of IIHMR lists a few existing models and regulations that ensure accessibility to healthcare services at affordable prices, for instance value based costing, new R&D models to increase access to affordable medicines like new partnerships to access new sources of innovation, open crowdsourcing, public private partnerships, accelerated efforts to enhance availability and quid pro quo – universally legally guaranteed coverage.
But these models are not without their weaknesses as management strategies aimed at controlling cost and utilisation create significant barriers to the accountability, affordability, and accessibility, rues Ramesh. Therefore new models of R&D need to be introduced to increase access to affordable (innovative) medicines like for instance, new partnerships to access new sources of innovation etc., reasons Ramesh.
Medication is just one part of the healthcare delivery chain. Pharma companies are therefore continuously reviewing their access programmes in response to gaps identified in the existing system. For instance, as Zia of Novartis says, “Our programmes go beyond just the pill to look at compliance and better health outcomes. Given the high patient load per doctor in India, counselling support services are offered to improve health outcomes through enhanced understanding of disease management, reinforced importance of therapy adherence, lifestyle modifications etc. Additionally, customised interventions such as microfinancing, discounted diagnostic support and other value added services are offered for select disease conditions that enable better health outcomes for various chronic diseases.
It is generally accepted that whatever is measurable, is easier to replicate. But in this the case of linking pharma companies’ access programmes to health outcomes, Iyer says that key gains are notoriously difficult to quantify, as there is very little reporting of health outcomes and impact and because many pharma programmes are running only for a short time so far. But there is progress because “10 years ago, we did not have this many companies engaging in poverty related disease R&D, starting and maintaining access programmes all over the world and certainly every company we have been evaluating has come some way in the last years.”
Sharing some more key takeaways from the Index especially for companies formulating their own access strategies, Iyer comments, “One important thing for anyone to realise is that access to medicine is going beyond philanthropy, and is part of normal corporate strategy in many MNC companies. These ensure more sustainability of programmes and thus are more likely to have a better health impact. When an MNC operates in India, they have to ensure that access to products and contribution to human, infrastructure development go hand in hand, so as to also get better health outcomes. As indigenous companies look at their access to medicine strategies, they need to carefully address the user’s needs and develop ways to improve access. Access based rather than sales based strategies are driving growth in countries like India.”
Thus it is evident that though a lot is being done, more can and needs to be done. Pharma companies cannot rest on their laurels and neither can governments rely solely on corporate funded programmes to secure the health of their citizens. Both sides need to find common ground and work towards achieving their goals, be it meeting the SDGs or more specific national health targets.
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