Activists, policy-makers, researchers and healthcare providers joined a leadership workshop led by ITPC’s Make Medicines Affordable campaign at AIDS 2020 at the start of the week (6 July). If you missed the session, or would like to recap, here are some of the highlights.
‘Prices can be low: Now don’t be slow! Innovative strategies to lower your medicines procurement costs’ looked at:
- The causes behind monopolies and high priced medicines.
- The impact of monopolies on procurement and health budgets.
- The policies and tools available in international agreements and national laws to address unfair monopolies.
- How utilising these tools can stimulate robust generic competition and significant price reductions.
- How funding civil society work results in dramatic savings.
“The ‘rationale’ behind drug prices has nothing to do with investment or research, or how difficult a drug is to make, but about how much profit a company can make,” explains Othoman Mellouk, Make Medicines Affordable campaign lead, speaking at the event.
Prior to 2005 and the World Trade Organization’s Aagreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), medicines were considered public goods. Since the introduction of TRIPS, medicines have been treated like any other commercial product. This includes granting patent protection and with that comes an initial 20-year monopoly.
“If patents are granted unopposed there is no competition for at least 20 years. This lack of competition allows companies to set prices inexplicably high,” says Othoman. “This overpricing directly affects public health policy: The higher the price, the less people will be treated.”
“However, within the TRIPS Agreement there are also ‘flexibilities’. While governments may grant patents as per the agreement, they can also reject patent applications which do not meet patentability criteria, such as the requirement to be genuinely new and innovative. Additionally, when patents have been granted governments can still bypass intellectual property protections if necessary, for example when high prices pose a threat to public heath. This is a legitimate action know as a ‘compulsory’ or ‘government use’ license.”
Kajal Bhardwaj, a lawyer working on human rights, public health and access to medicines, agrees: “Prevention is better than cure,” says Kajal. In this case she’s applying the well-known saying to patents. “It is better to prevent unmerited patents than to grant one and challenge it later. Every patent application does not need to be granted.”
Kajal explains that: “Most patent applications are for new forms, or a new use, of existing drugs. These are evergreening patents, designed to extend monopolies through multiple, overlapping patents. There can be hundreds of patent applications on one medicine. In cases of evergreening, when multiple applications are accepted, a monopoly extends well beyond 20 years. Do not grant these patents.”
“As patent applications have exponentially increased over recent years, patent offices have become more and more over-stretched. Civil society organizations have stepped in to help prevent the abuse of the patent system,” says Kajal.
“For patent offices, community groups and civil society are your allies. They review lengthy applications and provide informed scientific, legal and technical arguments for why those patent applications should not be granted. We now have a great list of successful patent opposition cases around the world, where civil society has been able to support the role of the patent office.”
“Take Argentina for example, here are just three recent cases, based on the excellent legal work by Fundación GEP, resulting in price reductions.”
- The starting price of HIV drug, Atripla (TDF+FTC+EFV) was $3567. After successful oppositions and the purchase of generic versions, the price dropped to $152.
- The original price of Truvada (TDF+FTC) was $2304. An opposition was filed in relation to the patent, which was then withdrawn, and the average price dropped to $883.
- Hepatitis C drug, sofosbuvir, was initially offered in Argentina for between $11000 and $15000 per person. Three years later, after Gilead’s unmerited patents were rejected, the price person for generic versions was $358.
“Where patents are granted, many developing countries have made effective use of compulsory licenses to allow generic competition for HIV, Hepatitis C, heart disease, and cancer medicines. Countries like Thailand effectively used compulsory licensing between 2006 and 2008 to support their universal health coverage programme, saving millions of dollars by procuring generic medicines instead of patented ones. Many countries are still dealing with higher prices of these medicines, but they don’t have to,” Kajal concluded.
Kajal also noted that all countries classified as least developed countries (LDCs) should not be granting or enforcing any patents on medicines until 2033.
WHY TRIPS FLEXIBILITIES ARE MORE IMPORTANT THAN EVER
“Relying on a single supplier is super dangerous,” says Othoman. “We have seen this during the COVID-19 pandemic, when protective equipment could only be sourced from one country, such as masks from China, and now the USA has been allowed to buy up the vast majority of Gilead’s stocks of remdesivir.”
“Countries must be self-sufficient. It is essential that TRIPS flexibilities are used; that there is local production; and public health is prioritised.”
“The old research and development argument, used by the pharmaceutical industry to claim that high prices are necessary, is hugely exaggerated. These days much of the research and clinical trials for drug development is funded by countries, as we’ve seen with COVID-19, and all drugs currently being used in clinical trials on the coronavirus are existing drugs that have been repurposed.”
Much of the research and clinical trials for drug development is funded by countries – Othoman Mellouk.
Despite the fact that drug development is typically a collaboration, with governments supporting research with public money, profit-led corporations are still obtaining monopolies – when and where they can get away with it.
In reaction to the COVID-19 pandemic, combined with the notorious track record of pharmaceutical companies, many governments have already stepped in to ensure they can access COVID-19 technologies and treatments for everyone in need, if and when treatments are proven to be effective.
“With regards to repurposed drugs – no country should be granting patents on these,” says Kajal. “If there are new, patented medicines for COVID-19, and it’s a possibility we may see this next year, then countries need to consider compulsory licenses.”
With regards to repurposed drugs – no country should be granting patents on these – Kajal Bhardwaj.
Governments in Israel, Germany, Chile, Colombia, Ecuador and Canada have taken action. Israel issued a compulsory license (CL) for an HIV drug being trialled in the treatment of COVID-19 (lopinavir/ritonavir). Other countries have changed national laws in order to more easily and rapidly facilitate CLs for any COVID-19 treatments. Brazil’s parliament is considering doing the same, and civil society organizations in Argentina and India have filed patent challenges on drugs being repurposed for COVID-19.
FOR DRAMATIC SAVINGS – FUND ACCESS TO MEDICINES WORK
“No public health strategy can be effective without supporting access to medicines work,” says Morgane Ahmar, Make Medicines Affordable partnership officer. “Governments and funders must really reflect and act on this.”
“Access to medicines in middle-income countries (MICs) particularly depends on this work.
MICs have a ‘triple penalty’ in that they are home to the majority of people living with HIV and are facing the highest burden of TB/HIV co-infection; they are frequently excluded from access to medicines mechanisms, such as voluntary licenses, enabling access to generic medicines; and additionally they are dealing with a trend of global defunding and transitioning from the Global Fund.”
Morgane, who is also on the Developing Country NGO Delegation for the Global Fund to Fight AIDS, TB and Malaria, says: “The Global Fund is a major actor in global procurement of generic medicines. There are several grants that include intellectual property (IP) and access to medicines interventions, and the Fund encourages countries to consider IP and procurement in their transition planning to ensure the sustainability of access to medicines.”
However, Morgane also believes that it could do more. “Even when a country has identified the potential barriers to accessing essential medicines after Global Fund support has been withdrawn, as countries transition, many are negatively affected by the shift. For example, Armenia released a national tender for first-line TB medicines. It failed because no company responded to the tender, resulting in a stockout. This occurred despite the fact that risks of failed tenders for HIV and TB drugs due to lack of registration were identified in Armenia’s Global Fund transition readiness assessment.”
Armenia released a national tender for first-line TB medicines. It failed because no company responded to the tender, resulting in a stockout – Morgane Ahmar.
“Funding for treatment advocacy should be included in transition planning and domestic funding lines. This work is effective. Interventions focused on removing IP barriers are strategic for both the Global Fund and countries alike. It not only reduces budgets for HIV, TB and malaria, it also has an impact on budget and public health outside of the three diseases, by resulting in stronger procurement systems and lower-priced medicines for other diseases, such as cancer, and it can do the same for COVID-19.”
“Access to medicines is a human right. Civil society action has proven to work, resulting in dramatic savings. Yet, we observe a decrease in funding for such interventions. Funding this work will save money in the long-term and is critical to sustain the gains we have achieved so far,” concludes Morgane.