A right time to shift pharma gears

We are living in the shadow of the COVID-19 pandemic — anxious about our families, our friends and ourselves, depressed by worldwide suffering and anxiety, upset by knowing that once more the poor and marginalised are worse affected. Could the rules and practices organising health care around the world have been better suited to this outbreak? Consider the Health Impact Fund as a plausible institutional reform of the current regime for developing and marketing new pharmaceuticals.

Medicines are among humanity’s greatest achievements. They have helped attain dramatic improvements in health and longevity as well as huge cost savings through reduced sick days and hospitalizations. The global market for pharmaceuticals is currently worth ₹110 crore lakh annually, 1.7% of the gross world product (IPFPA 2017, 5). Roughly 55% of this global pharmaceutical spending, ₹60 lakh crore, is for brand-name products, which are typically under patent.

Also read | Biologics, patents and drug prices

Commercial pharmaceutical research and development (R&D) efforts are encouraged and rewarded through the earnings that innovators derive from sales of their branded products. These earnings largely depend on the 20-year product patents they are entitled to obtain in WTO member states. Such patents give them a temporary monopoly, enabling them to sell their new products without competition at a price far above manufacture and distribution costs, while still maintaining a substantial sales volume. In the United States, thousandfold (100000%) markups over production costs are not atypical. In India, the profit-maximising monopoly price of a new medicine is much lower, but similarly unaffordable for most citizens. To be sure, before such huge markups can yield any profits, commercial pharmaceutical innovators must first cover their large R&D costs, currently ₹14 lakh crore a year (Mikulic 2020), including the cost of clinical trials needed to demonstrate safety and efficacy, the cost of capital tied up during the long development process, and the cost of any research efforts that fail somewhere along the way.

R&D and concerns

While we should evidently continue funding pharmaceutical R&D, it is worth asking whether our current way of doing so is optimal. There are three main concerns. First, innovators motivated by the prospect of large markups tend to neglect diseases suffered mainly by poor people, who cannot afford expensive medicines. The 20 WHO-listed neglected tropical diseases together afflict over one billion people (WHO n.d.) but attract only 0.35% of the pharmaceutical industry’s R&D (IFPMA 2017, 15 and 21). Merely 0.12% of this R&D spending is devoted to tuberculosis and malaria, which kill 1.7 million people each year.

Second, thanks to a large number of affluent or well-insured patients, the profit-maximising price of a new medicine tends to be quite high. Consequently, most people around the world cannot afford advanced medicines that are still under patent. This is especially vexing because manufacturing costs are generally quite low. Every year, millions suffer and die from lack of access to medicines that can be mass-produced quite cheaply.

Also read | Price control on drugs is lazy thinking

Third, rewards for developing and then providing pharmaceutical products are poorly correlated with therapeutic value. Firms earn billions by developing duplicative drugs that add little to our pharmaceutical toolbox — and billions more by cleverly marketing their drugs for patients who won’t benefit. These large R&D investments would be much better spent on developing new life-saving treatments for deadly diseases plaguing the world’s poor.

To address these problems, we propose a complement to the present regime: the Health Impact Fund as an alternative track on which pharmaceutical innovators may choose to be rewarded. Any new medicine registered with the Health Impact Fund would have to be sold at or below the variable cost of manufacture and distribution, but would earn ten annual reward payments based on the health gains achieved with it.

On funding

The Health Impact Fund could start with as little as ₹20000 crore per annum and might then attract some 10-12 medicines, with one entering and one exiting in a typical year. Registered products would then earn some ₹17000-₹20000 crore, on average, during their first ten years. Of course, some would earn more than others – by having greater therapeutic value or by benefiting more people.

The Hindu Explains | How are drug prices regulated?

Long-term funding for the Health Impact Fund might come from willing governments — contributing in proportion to their gross national incomes — or from an international tax, perhaps on greenhouse gas emissions or speculative financial transactions. Non-contributing affluent countries would forgo the benefits: the pricing constraint on registered products would not apply to them. This gives innovators more reason to register (they can still sell their product at high prices in some affluent countries) and affluent countries reason to join.

The Health Impact Fund would get pharmaceutical firms interested in certain R&D projects that are unprofitable under the current regime – especially ones expected to produce large health gains among mostly poor people. Such projects would predominantly address communicable diseases, which continue to impose devastating disease burdens mainly upon the poor. With the Health Impact Fund in place, there would be much deeper and broader knowledge about such diseases, a richer arsenal of effective interventions and greater capacities for developing additional, more targeted responses quickly. Pharmaceutical innovators would thus have been much better prepared to supply or develop suitable medicines for containing the COVID-19 outbreak.

The Health Impact Fund would make an important difference also by rewarding for health outcomes rather than sales. For selling a medicine, it helps, of course, if this medicine is known to be effective. But it is quite possible to sell a relatively ineffective drug or to sell a drug to patients who will not benefit from it or would benefit more from another. With exorbitant markups, this sort of thing happens often: firms seek to influence hospitals, insurers, doctors and patients to use their patented drug and to favour it over others.

Also read | 42 non-scheduled cancer drugs brought under price control

For achieving health gains with their product, innovators need different strategies. They need to think holistically about how their drug can work in the context of, or in synergy with, other factors relevant to treatment outcomes. They need to think about therapies and diagnostics together, in order to identify and reach the patients who can benefit most. They need to monitor results in real time to recognize and address possible impediments to uptake or therapeutic success. They need to ensure that high-value patients have affordable access to the drug and are properly instructed and motivated to make optimal use of it with the drug still in prime condition. In sum, a reward mechanism oriented towards health gains rather than high-markup sales would lead to a sustainable research-and-marketing system that is better prepared for fast and effective responses to outbreaks of unknown diseases, such as COVID-19.

Issue of state risk

Participation of commercial pharmaceutical firms is crucial for tackling global pandemics. They are best suited to develop and scale up provision of new vaccines and medications fast. At present such firms do, however, face discouraging business risks from governments who may — as some have done — use compulsory licences to divest them of their monopoly rewards. Health Impact Fund registration would remove this risk as states would have no reason to interfere with innovators whose profit lies in giving real and rapid at-cost access to their new product to all who may need it (Hollis and Busby 2020).

Nowhere is this focus on results, which the Health Impact Fund would encourage in innovators, more important than in the domain of communicable diseases. A firm rewarded for merely selling malaria drugs need not be distraught by the fact that malaria continues to infect over 20 crore people each year (WHO 2019, xii), killing 5 lakh of them. A firm rewarded for making its medicine reduce the malaria disease burden, by contrast, would aim to decimate the proliferation of malaria as rapidly and cost-effectively as possible. Collaborating with national health systems, international agencies and NGOs, such a firm would seek to build a strong public-health strategy around its product. Its highest goal would be complete eradication. If it succeeds in year seven, it can enjoy the world’s gratitude and collect three additional handsome reward payments for investment in its other research projects.

Also read | National Pharmaceutical Pricing Authority hikes cost of 12 essential first-line treatment drugs

Applying this point to a new disease like COVID-19 is complicated by the fact that we lack here a well-established baseline representing the harm the disease would have done in the absence of the new medicine to be assessed. For malaria, such a baseline can be established on the basis of a stable disease trajectory observable over many years. In the case of a new epidemic, one must rely on a modelling exercise that estimates the baseline trajectory on the basis of obtainable data about the spread of the disease and its impact on infected patients. This surely is a challenging undertaking which cannot yield precise or uncontroversial results about what damage the epidemic would truly have done if the vaccine or medication in question had not appeared.

Still, despite the roughness of such a modelled baseline, the Health Impact Fund would give innovators the right incentives. It would guide them to ask not: how can we develop an effective product and then achieve high sales at high markups? But rather: how can we develop an effective product and then deploy it so as to help reduce the overall disease burden as effectively as possible? The COVID-19 pandemic should make us stop and think: which of these two questions should be guiding our pharmaceutical innovators?

Felicitas Holzer is a researcher in the Bioethics Center and Bioethics Network of the World Health Organization at the social science faculty of FLACSO in Buenos Aires, Argentina, and a Coordinator for governmental relations at Incentives for Global Health (IGH). Thomas Pogge is Leitner Professor of Philosophy and International Affairs and founding Director of the Global Justice Program at Yale. He is co-founder of Academics Stand Against Poverty (ASAP), an international network aiming to enhance the impact of scholars, teachers and students on global poverty, and of Incentives for Global Health, a team effort toward developing a complement to the pharmaceutical patent regime that would improve access to advanced medicines for the poor worldwide

An error regarding the worth of the global market for pharmaceuticals has been rectified.

Related Topics
Recommended for you
This article is closed for comments.
Please Email the Editor

Printable version | Sep 26, 2020 12:00:56 PM |

Next Story