Commercial Excellence & Market Access South Africa

Mar 8, 2016 - Mar 9, 2016, Johannesburg

Remove barriers to prescribing. Achieve the highest level of access to patients.

Making Medicine Accessible to All

Two billion people on the planet do not have access to medicines. How is the pharmaceutical industry trying to change this?



As the rich get richer, and the poor get poorer, we can be simply divided into a planet of haves, and have nots.

What one may view as an automatic right, however, may be seen as a luxury for some people. Basic medicines fall into the latter category for a staggering two billion of the world’s population.

The Irish Forum for Global Health, in partnership with the Centre for Global Health, Trinity College Dublin, recently held an event in Dublin entitled “2 Billion to Go: Pharmaceutical Companies’ Role in Improving Access to Medicines”.

The Irish Clinical Program Lead for Global Health, Dr David Weakliam, opened the meeting by explaining that “AIDS changed everything”.

It was announced earlier this summer by the Joint United Nations Program on HIV/AIDS (UNAIDS) that the goal of 15 million people on life-saving HIV treatment by 2015 has been met, a full nine months ahead of schedule, the consultant in public health medicine told the packed room.

This is an “astonishing achievement”, and one of the greatest in global health, Dr Weakliam told the audience.

Yet the cup remains half full, and Mr Wim Leereveld, CEO and Founder of the Access to Medicine Foundation, was present to explain how their Access to Medicines Index hopes to build on this and achieve much greater access to lifesaving therapies.

So what is the Access to Medicines Index? The Index assesses the efforts of pharmaceutical companies to improve access to medicines in low and middle income countries. First completed in 2008, the Index is now published every two years and independently ranks 20 leading research-based pharmaceutical companies on their policies and practices, in relation to specific ranges of countries, diseases and product types.

The most recent Index was published in 2014 (Table 1) and Leereveld explains that the results identify clear opportunities for pharmaceutical companies wishing to improve access to their products.

In addition, competition between companies can be fierce – those at the top of the index are willing to work hard to stay there, while others are always trying to improve their ranking.

Indeed Bill Gates, whose charitable Bill and Melinda Gates Foundation helps to fund the Initiative, has been quoted as saying: “The companies at the top want to do more. The ones at the bottom see that and push forward on it.”

Complex

So just how are the companies ranked? The Index reports on these companies’ access-related policies and practices based on an analysis of 95 indicators, in relation to 106 countries and 47 different diseases.

The precise methodology framework employed by the Initiative is unsurprisingly complex, and is continuously refined, but essentially aims to grade companies in seven technical areas of corporate activity that they see as key to enabling access to medicines in developing countries. These are:

1. Access to Medicine Management 

2. Public Policy & Market Influence

3. Research & Development

4. Pricing, Manufacturing & Distribution

5. Patents & Licensing

6. Capability Advancement

7. Donations & Philanthropy

Within each area, the Index assesses four aspects of company action: commitment, transparency, performance and innovation. Company scores in each of these areas are weighted according to their importance for access and then combined to form companies’ overall Index ranking scores.

The most recent Index, published in November 2014 had GSK top of the pile for the fourth time, followed by Novo Nordisk and Johnson & Johnson.

“You need to show that a company actually has long-term, sustainable, commitments to improving access,” explained Dr Jayasree Iyer, Head of Research with the Initiative.

The companies agree that it makes them think harder; not only about facilitating access to their products, but about their entire innovation strategy.

“The Index challenges us to think harder about how we drive innovation and enable access to our products,” GSK CEO Sir Andrew Witty is quoted as saying.

Leaders

So what are companies near the top of the Index doing that is so right? Iyer explained that leaders perform well across most areas of investigation.

“They typically have strong research pipelines, have pricing strategies that target the poor, and manage IP in ways that stimulate competition. Top performers innovate constantly, usually in several technical areas. However, progress is not equal across all areas or among companies, and there are some areas where the industry as a whole remains static,” she said.

Analysis of the final Index brings out best practices and examples, highlights areas where progress has been made and also areas where critical action is required. Iyer echoed Leereveld’s opinion that no company is happy with its position on the index.

“It is hard to be number one and it is hard to remain number one, and there are many reasons why GSK are number one but they need to continue to prove that their practices are at the very, very top of the rank. But the company that is 20th has 19 other companies to learn from.”

Another side-function of the Index is that it serves to highlight industry trends – interestingly, according to the findings of the 2014 Index, five companies are developing more than half of pipeline products for developing countries. The top 20 pharmaceutical companies are developing 327 relevant products, with more than half targeting the same five disease.

Iyer explained that the Index is constantly evolving; refinements to the Index methodology for 2014 brought additional Latin American countries, including Brazil, into the Index's scope, as well as additional diseases, such as mental health disorders and hepatitis C. The focus of the pricing analysis also shifted, and now solely captures pricing strategies that explicitly take affordability into account, she added.

Just giving?

In terms of direct donations, Iyer explained that there is an argument against pure financial assistance being taken into account by the Index.

“But we believe it is essential for the very poor, and also for specific areas like tropical diseases, donations are the only way to eradicate diseases, and we found in the last two years there has been a significant increase in commitment from the pharmaceutical industry in increasing donations.”

The Index also provides a basis for multi-stakeholder dialogue and solution building. Iyer says the importance of local stakeholder engagement by companies is becoming increasingly apparent.

“We used to believe that access to medicines was purely something to be discussed at the headquarters. But now we find that about eight companies have found a systematic way of ensuring that stakeholder engagement, in terms of ideas and innovation is possible, testing if their ideas are welcome and are making an impact, at the local level. This is increasing over time and will be something we monitor as we work on the next Index.”

A new Access to Vaccines Index is the next step for the Foundation, and the methodology for this is currently being developed by the Foundation, with support from stakeholders and vaccine experts, and is planned for publication early in 2017.

“Access to vaccines is an area that people say should be confined to immunization programs delivered via Governments but there is still a very strong role for pharmaceutical industry in this. High prices for vaccines have been criticized in the news. We will be looking not only at affordability but manufacturing, distribution and supply,” explained Iyer.

Concerns

Work continues on the 2016 Index, however, and there is much food for thought.

The 2014 Index highlighted two main areas of concern for industry; 18 companies have been the subject of settlements or decisions relating to breaches in ethical marketing bribery or corruption standards or competition laws, while almost all companies remain conservative in their disclosure of patent status. Within the reporting period, no company independently disclosed its patents statuses for any product relevant to the Index.

A huge positive, however, is that pricing strategies are becoming increasingly tailored, with companies paying more attention to socioeconomic factors, Iyer explained.

“It is good news and bad news. While they are more tailored, we found that out of 700 products, only a third of them are actually targeting the poorest customers and have shown true affordability. There is still a long way to go – the cup is just one-third full. But our report provides something for companies to act on.”

In terms of R&D, the most recent Index found that companies with the strongest relevant pipelines also have strong R&D strategies that are based on meeting the needs of patients in low-income and middle-income countries. Iyer explained that the industry is developing a substantial number of products for high-burden diseases, most of which are already in clinical development.

Indeed, more companies are experimenting with innovative access-oriented business models. Good examples include Merck & Co. offering patients in 11 cities in India zero-interest loans for the purchase of one of its hepatitis medicines; and Novo Nordisk making insulin products more accessible in India, Nigeria, Ghana and Kenya by identifying ways to integrate diagnosis, treatment and control in local communities. However, the impact of such models remains to be seen, says Iyer.

Promisingly, almost half of product development is now collaborative, with public partners involved, she added.

“The involvement of public partners is directly correlated with greater transparency and access provisions. This may not sounds like rocket science to most people as it seems quite logical, but we put a number on it and it turns out that in the last five years there’s been a 35 per cent in public private partnerships. This means that the products that reach the market on foot of these partnerships have a much higher chance of being affordable, registered in the right markets and have a price cap of some sort.”

The next step

Progress is admittedly uneven, but comparisons between the first Index in 2008 and the most recent illustrate the significant headway that is being made. But as with any ranking system, the question must be asked: are pharmaceutical companies merely competing against each other or are they truly trying to maximize access to medicines in the developing world? Leereveld disagrees on both grounds – he believes efforts are based on true altruism coupled with good business sense.

“How I see pharmaceutical companies is that they are like you and me – when they see the problems in those countries they want to help, and they think how can they play a role, like we all do. I believe in the people within pharma companies, but how can those people convince the bosses in the head office of the fact that it is also in their best business interests? There must also be a business incentive otherwise it is not sustainable.”


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Commercial Excellence & Market Access South Africa

Mar 8, 2016 - Mar 9, 2016, Johannesburg

Remove barriers to prescribing. Achieve the highest level of access to patients.

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