ATM: Pharma fails to make drugs affordable to those who need them most

LONDON – The pharmaceutical industry has made no progress over the past two years in making drugs more affordable in low and middle income countries.

In addition, companies need to do more to develop access plans when products are in development, to ensure new drugs are more swiftly registered and made widely available once the first approval is granted, according to the fifth Access to Medicines (ATM) Index, published on Monday.

“Good practice in making products affordable and available is limited,” the ATM stated. Companies do not systematically target populations with the highest needs, in registration or pricing.

Overall, “moderate progress” can be seen in the industry’s efforts to improve access, especially in relation to how access programs are organized, in the development of appropriate products, waiving patent rights in the poorest countries and granting licenses for generics manufacturing.

Improving access is increasingly seen as a strategic approach to developing business in emerging markets and 17 of the 20 companies in the index now have specific access programs, according to ATM, which has published its ranking every two years since 2008.

ATM uses a framework of 83 metrics to measure company performance relating to 51 high burden diseases in 107 countries, and examines whether drugs are priced fairly in countries with the greatest need for specific products.

The work is funded by the U.K. and Dutch governments and the Bill & Melinda Gates Foundation.

It does appear that the industry is making serious attempts to fill the gaps where there is urgent unmet need, but little commercial incentive to carry out research.

Currently, the 20 companies in the index are developing 151 products that address 31 gaps in provision, as identified by external experts. However, the ATM finds that six companies account for the bulk of that activity.

Public-private partnerships and collaborative research have been effective in drawing in pharma to develop urgently needed products, and also are more likely to include access plans than in in-house projects.

“Globally, 2 billion people cannot access the medicines they need,” said Jayasree Iyer, executive director of ATM. “When [pharma companies] take the positive steps, the impact on access can be huge with significant savings for health care budgets.”

However, Iyer added, “Progress is slower than many of us would like.”

The ATM has drawn up a list of countries by priority of need in each of 51 diseases it covers and examined the extent to which companies register their newest products in those countries. It finds that new and needed drugs are registered in only 25 percent of the countries on the list.

For the newer drugs that are registered in low and middle income countries, companies are bearing in mind affordability for more products than in 2014, but the proportion of the industry’s portfolio covered by equitable pricing schemes remains the same.

Overall, only 44 products of 850 are covered by pricing strategies that meet ATM’s criteria for affordability. Just three companies, Glaxosmithkline plc, Sanofi SA and Astrazeneca plc are responsible for the majority of equitable pricing schemes.

MEAGER IMPROVEMENTS

Licensing to allow generics companies to manufacture products that retain intellectual property rights has expanded, with 16 pharmas waiving patent rights, an increase of seven compared to 2014. The licensing agreements vary in their breadth and scope.

More HIV/AIDS drugs are covered by voluntary licenses than in 2014, and for the first time licenses have opened up access to hepatitis C treatments.

While the ATM sees this as encouraging, it noted also that none of the licenses apply to large countries, including Mexico, Thailand and Ukraine, which despite being classified as middle income, are home to the majority of the worlds’ poor and shoulder the greatest burden of global disease.

In addition, weak enforcement of companies’ internal compliance systems is limiting access to medicines. “Breaches of laws or codes relating to corruption, unethical marketing and anti-competitive behaviour continue to arise,” the ATM stated.

Of the 20 companies in the index, only Abbvie Inc., Eisai Inc., Gilead Sciences Inc. and Novo Nordisk A/S were not found by a court or regulator to have breached criminal or civil laws, or codes of conduct related to corruption or unethical marketing.

A total of 51 settlements relating to some form of malpractice were identified by ATM. However, that was 22 fewer than in the 2014 index. Companies are at greater risk of non-compliance by staff in low and middle income countries where regulatory systems are likely to be weaker, underscoring the need for strong enforcement of compliance systems.

Overall, poor compliance, “May be undermining the success of [pharma companies’] access to medicines strategies,” according to the ATM.

The starting inputs for the ATM analysis are questionnaires completed by individual companies. The submissions are then scrutinized by independent experts, drawing on public data sources.

Roche AG dropped from 12th to 19th position from 2014 to 2016 after refusing to provide data for analysis, forcing ATM to rely on public data and information from past submissions to make the assessment. Roche justified its own position by saying its main focus for improving access is oncology, which is not within the scope of the index.

The top position in the index was taken by Glaxosmithkline for the fifth time in a row. CEO Andrew Witty said fundamental changes to the business model enable the company to make its products as available and affordable as possible, while generating the returns needed to sustain the business.

“We cannot stand still. Increasing access is a complex and ongoing challenge, which is reflected in this year’s index being more demanding than ever. As a business, and an industry, we must push ourselves to go further and faster in strengthening access to health care,” Witty said.

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