pandemic
Health workers don personal protective equipment before attending to patients with COVID-19.

After months of protesting about the lack of space for civil society in the World Health Organization’s (WHO) pandemic agreement negotiations, the Pandemic Action Network (PAN) is hosting two community meetings next week – and it expects member states to show up and listen.

The meetings take place next Wednesday and Thursday (21 and 22 February), in the midst of a two-week meeting of the Intergovernmental Negotiating Body (INB).

“Groups from across civil society have worked hard to create opportunities for civil society organisations’ (CSO) voices to be heard by the INB negotiators to the pandemic agreement, including for next week – what we need is a cast-iron guarantee from member states that they will show up, listen and consider incorporating civil society asks into the agreement,” says Eloise Todd, PAN’s executive director and co-founder.

“The future agreement will be more effective if it builds on civil society and community lived experience and learnings from the vast inequities of the COVID-19 pandemic and other pandemics. 

“We call on CSOs around the world and based in Geneva to join us for these sessions, and our message to member states is clear: we hope and expect to see you there,” adds Todd.

INB co-chairs Precious Matsoso and Roland Driece will attend both meetings, which will take place during the INB’s lunch breaks from 12:45 to 13:45pm (CET) on both days in a WHO meeting room near the negotiations in Geneva.

The first meeting will include a focus on “access and benefit sharing”, while the second will include “accountability and institutional arrangements”.

 

PAN has invited both civil society organisations and member states to register for the meetings either virtually or to attend in-person. The deadline for in-person registration is close-of-business on Monday 19 February.

“To help ensure the world is equipped to prevent, prepare, and rapidly respond to the next

pandemic, the INB process must result in a meaningful, ambitious, and accountable agreement that goes beyond business as usual,” says PAN.

“To do so, civil society expertise, support, and engagement are critical. These meetings will provide an opportunity for civil society to share feedback and recommendations on the evolving text.”

The eighth INB meeting begins on Monday as negotiators knuckle down for the final stretch before their May deadline.

PAN and its over 70 partners have asked member states to  “cement equity, accountability, financing, prevention, and gender in the final agreement”.

Tedros hits out at ‘lies’

Meanwhile, WHO Director General Dr Tedros Adhanom Ghebreyesus hit out at the “litany of lies and conspiracy theories” aimed at undermining the pandemic agreement in an address to the World Governments Summit in Dubai on Monday.

“We cannot allow this historic agreement, this milestone in global health, to be sabotaged by those who spread lies, either deliberately or unknowingly,” said Tedros.

“Let me be clear: WHO did not impose anything on anyone during the COVID-19 pandemic. Not lockdowns, not mask mandates, not vaccine mandates. We don’t have the power to do that, we don’t want it, and we’re not trying to get it.

“Our job is to support governments with evidence-based guidance, advice and, when needed, supplies, to help them protect their people. But the decisions are theirs. And so is the pandemic agreement. It has been written by countries, for countries, and will be implemented in countries in accordance with their own national laws,” he added.

“Far from ceding sovereignty, the agreement actually affirms national sovereignty and national responsibility in its foundational principles.”

Image Credits: U.S. Army National Guard/Edwin L. Wriston, Tehran Heart Centre .

Intergovernmental Negotiating Body meeting over a new pandemic accord in November 2023

A wide array of stakeholders are looking toward the upcoming World Health Assembly this May to conclude negotiations on a new pandemic accord that seeks to make the world more prepared for the next pandemic.

And most would agree that the primary task of the Intergovernmental Negotiating Body (INB), established by the World Health Assembly (WHA) in December 2021 to negotiate the draft agreement, is to address the inequities observed in the distribution of COVID-19 vaccines, medicines, diagnostics and other  countermeasures to low- and middle income Countries (LMICs).

In this respect our collective response failed, in particular to Africans, and this should never be allowed to happen again. With this in mind, the biopharmaceutical industry, represented by IFPMA, tabled the Berlin Declaration in July 2022, committing to early and equitable access by reserving an allocation of real-time production of vaccines, treatments, and diagnostics for priority populations in lower-income countries, as well as taking measures to make them available and affordable.

Solutions being proposed by the INB negotiators must undeniably put equity front and centre. However, in doing so, we should not jeopardize the elements of the COVID-19 response that worked well, notably, the rapid development and scale up of medical countermeasures and the unprecedented public-private partnerships that helped end the pandemic by May 2023.  Without these successful elements, there will be life-threatening delays in developing the medical countermeasures that will be needed to fend off the next pandemic.

Pathogen Access Benefit Sharing (PABS) System proposal is deeply flawed

The genetic map to the SARS CoV2 virus was shared within days, ensuring rapid development of countermeasures.

As INB negotiators discuss a Pathogen Access Benefit-Sharing (PABS) System as part of an overall Pandemic Agreement, it is critical to preserve the innovation system and research incentives that were so successful in the fight against COVID19 and supported the rapid development of vaccines, treatments and tests at record speed and unprecedented scale. Failing to do so will mean we do not effectively tackle the biggest shortcoming of the COVID-19 pandemic – the inequitable rollout of medical countermeasures.

It is essential that provisions of the pandemic accord regarding access to pathogens and genetic sequences provide a decoupled solution, with no strings attached.  During the COVID-19 pandemic, access to pathogens and genetic data was swift and unconditional. Thankfully, no country tried to impose national legislation, related to the Nagoya ABS Protocol, to such sharing – something that could have considerably slowed rapid scientific response.

 WHO/INB pandemic accord negotiating document of October 2023

Unimpeded sharing of SARS-CoV-2 pathogen data enabled the development of a safe and effective COVID-19 vaccine within a record 326 days from the release of the virus’ genetic sequence. Without this principle, private sector engagement will be disincentivized and the measures will prove counterproductive.

Creating a “closed system” that centralizes pathogen access under one organization’s control, as some parties have proposed, would introduce considerable bureaucratic hurdles and could require years, if not decades, to implement.

This centralized approach offers no evident benefits whereas a more realistic approach involves bolstering collaboration among established networks such as European Virus Archive Global (EVA-G), American Type Culture Collection (ATCC), or the German Collection of Microorganisms and Cell Cultures (DSMZ).

Stringent requirements for sharing or accessing pathogen data would also severely hinder responses to future pandemics and basic research and development (R&D). Conditions, uncertainties, and negotiations surrounding pathogen access will cause delays in the developing medical countermeasures, leading to significant public health consequences, including loss of lives and unnecessary economic pressures. In the COVID-19 pandemic context, even a one-month delay could have meant an extra 400,000 lives lost.

Four key criteria for a PABS System

R&D for COVID-19 vaccine candidates proceeded at an unprecedented pace.

To prevent future delays in critical R&D of countermeasures, the WHO Pandemic Accord must include four key criteria:

  • Enable a flexible, decentralized pathogen sharing system leveraging existing networks and databases,
  • Establish a legally enforceable obligation for all countries to promptly share pathogen samples and sequence data,
  • Implement a legally binding presumption of consent for accessing pathogens,
  • Legally recognize the Accord as a Specialized International Instrument under Article 4, Paragraph 4 of the Nagoya Protocol. This would avoid any delay that could otherwise be created from national ABS laws, which are designed to protect claims by countries to their indigenous biological resources – not dangerous pathogens.

Moreover, pathogens or their genetic sequences aren’t “owned” by any single country; they quickly traverse borders. The idea of incentivizing or paying royalties to countries for spreading dangerous pathogens is outright absurd.

In instances where the Nagoya Protocol was applied, the results have been negative, as demonstrated in a 2023 report by the consultancy firm Covington, which reviewed the application of the Nagoya Protocol, for example in the case of the outbreak of Zika virus in 2015 and seasonal influenza in 2021.

Governance and implementation

Standing ovation at November 2021 special World Health Assembly session that voted to negotiate a new pandemic accord during the height of the COVID pandemic.

Effective governance and implementation are also important.  This means involving all of those parties which will contribute to the success of any Pandemic Accord, including through consensus-based decision making. Conversely, top-down decision making, without clear criteria, would undermine the trust that is necessary for the system to function. Excluding manufacturers from serious discussions about the PABS viability during the ongoing negotiations, especially given that most public health emergencies of international concern (PHEIC) are of no commercial interest, is simply wrong.

The private sector must be involved, and we must avoid overlaps, whereby manufacturers willing to sign up to the public-private partnerships created by the Pandemic Accord would be exposed to benefit sharing obligations and to national Nagoya ABS provisions.

To be practicable, the partnership should reach a critical mass to come into force – the idea of coercing companies to engage is unrealistic. Considering the free movement of pathogens and the potential refusal of major jurisdictions to join the PABS framework, this would create an uneven playing field for manufacturers based on their origin.

PABS cannot be built like the Influenza Preparedness System

Another issue is that the current draft text introduces very problematic clauses on mandatory contributions to finance the PABS, likely conflicting with several national constitutions.

National tax regimes are a matter beyond the constitutional jurisdiction of WHO, and any concept of “annual monetary contributions based on size and nature of the manufacturer” essentially amounts to a corporate tax.

While some may argue this mirrors the Pandemic Influenza Preparedness (PIP) system, which is designed to with “voluntary” contributions, this model is not suitable for pathogens in general and will not work.

Unlike the seasonal influenza market, where WHO and its Global Influenza Surveillance and Response System (GISRS) are basically the sole repository of biological influenza samples and the small number of companies involved in the seasonal influenza market rely on access to the WHO-owned samples, the landscape for known or unknown pathogens, let alone genetic sequence data, is vastly different.

The fact that the SARS-CoV2 Omicron variant was rapidly sequenced in parallel in South Africa, Botswana, and Hong Kong, is a prime example.  Restricting access to such data would hamper public health objectives by undermining the fast development of medical countermeasures (MCM). While companies do support surveillance and health systems strengthening, their contribution must remain voluntary.

Ensuring a more equitable rollout

The PABS system shoudl provide a credible solution to more equitable rollout of medical countermeasures.

Moreover, the PABS system should provide a credible solution to ensure a more equitable rollout of medical countermeasures, which the current proposal before the INB would fail to achieve. Achieving equitable access to vaccines, drugs, diagnostics and other tools demands a comprehensive approach, free from linking access to pathogen samples and sequence data to benefit-sharing obligations.

Through the Berlin Declaration, the industry has already expressed its commitment to early and equitable access by reserving an allocation of real-time production of vaccine, treatments, and diagnostics for priority populations in lower-income countries and to take measures to make them available and affordable. Such commitments should not hinge on the conditionalities of access to pathogens.

The Pandemic Accord should seek to engage companies and solidify the commitments made in the Berlin Declaration – not disincentivize them.

Proposals that include unrealistic conditionalities for pathogen access, and that disregard the ubiquity of pathogens that travel across borders, would fail to achieve a fairer distribution of medical countermeasures and risk significant delays to any pandemic response.

Towards equitable access

An effective agreement would follow a fundamental principle ingrained in medical practice: do no harm. It is essential to preserve successful elements from the fight against COVID-19 – such as fast, unhindered access to pathogens, a robust innovation ecosystem and unprecedented public-private partnerships – and focus on how to address the inequitable rollout of medical countermeasures. Conversely, an Accord that creates multiple barriers to pandemic preparedness and response, would do more harm than good.

Industry supports a comprehensive partnership involving GAVI, CEPI, the Global Fund, the WHO, and the private sector to enhance equity. The private sector is integral in the co-creation of solutions, and therefore must be consulted in a meaningful way – particularly given the role the sector will play in responding to future pandemics.

Companies have been stating for over a year that they are prepared to commit to pre- and during- pandemic measures including: improving surveillance; research on pathogens of pandemic potential; voluntary licensing and technology transfer based on mutually agreed terms to improve geographic diversity of manufacturing’; and real-time allocation of part of production, and equity-based tiered pricing.

For the Accord to succeed, constructive strategies to enhance pandemic prevention and preparedness through health systems strengthening, improved surveillance, and a decoupled approach to accessing pathogens and genetic sequences are critical.  Additionally, we need joint commitments from countries to procure additional medical countermeasures for the Accord partnership. Similar commitments from the industry should be accompanied by regulatory convergence and removal of trade barriers.  Furthermore, decentralized governance and implementation of the Accord through a partnership approach that includes the private sector are other crucial elements.

It’s not too late. An effective pandemic agreement will require the contribution of all stakeholders, acting in cooperation. Industry is keen to provide evidence and experience to the negotiators and we are eager to take our responsibility and make a positive contribution to a practical agreement. The world cannot afford to miss this opportunity.

Thomas Cueni is the Director General of the International Federation of Pharmaceutical Manufacturers and Associations. 

Image Credits: NIAID-RML , Pfizer, NPHCDA.

Bacteria
Close to 5 million deaths are associated with antimicrobial resistance (AMR) globally in 2019

The WHO has released a first-ever list of 21 antimicrobials earmarked as “authorized for use in humans only” – a first for the organization in its efforts to protect overuse and abuse of critical first-line drugs that need to be protected by overuse in animal and plant health sectors – and consequent antimicrobial resistance (AMR). 

Significantly, most of the 21 antimicrobials earmarked by  WHO as “authorized for use in humans only” include mostly novel compounds developed and authorized over the past six years. 

The category “mainly contains newer antimicrobials that are very important in treating serious multidrug-resistant infections in humans,” WHO explains in its guidance. So the new WHO label is effectively a warning sign to the farm industry that they should not be used in animals or plants in the future. 

Among the antimicrobials authorized “for use in humans only” are: plazomicin, aminomethylcycline, anti-pseudomonal penicillins with and without β-lactamase inhibitors, carbapenems with or without inhibitors, third- and fourth-generation cephalosporins with β-lactamase inhibitors, sulfones, as well as drugs critical to treating tuberculosis and other mycobacterial diseases.

Some of the older ones on the WHO list, e.g. carbapenems, are not licensed for use in animals in the United States, but are sometimes used in companion animals. 

The report aims to provide guidance for authorities in the public health and animal health sectors, veterinarians, prescribers of antimicrobials, and agricultural professionals, as well as classify antimicrobial categories by importance to human use, WHO said.   

Reducing risks to human health 

Antibiotics are commonly overused in animals—often without the input of veterinarians—to boost their growth and keep them from picking up infections.

A second category of medically important antimicrobials refers to drugs “authorized for use in both humans and animals.” 

But this is further broken down into “highest priority critically important antimicrobials (HPCIA),” “critically important antimicrobials (CIA),” “highly important antimicrobials,” and “important antimicrobials.” 

Widespread animal use of leading antibiotics has become a major driver of growing ‘superbug’ resistance to common drug treatments, or AMR. In 2019 AMR was associated with the deaths of close to 5 million people globally. 

To address these risks, the use of critical antimicrobials needs to be rationalized more systematically in both animal as well as human health. WHO’s drug classifications create an order of priority for doing this, notes an analysis from the University of Minnesota-based Center for Infectious Disease Research and Policy (CIDRAP.) 

“The risk to human health is greatest if the antimicrobials listed as ‘authorized for use in humans only’ are used in non-human sectors,” noted the CIDRAP analysis. “Those risks and impacts decline progressively with the use of agents from the other categories.”

“For instance, the criteria for inclusion in the first two medically important antimicrobial categories is whether the antimicrobial class is one of the limited available therapies or the sole available therapy to treat serious bacterial infections and if it’s used to treat bacterial infections possibly transmitted from non-human sources (such as Salmonella and Escherichia coli).

“Among the classes categorized as HPCIA are third- and fourth-generation cephalosporins, quinolones, and polymyxins. The CIA category includes aminoglycosides and macrolides,” CIDRAP noted. 

Antimicrobial risk scale

Scale of prioritization of medically important antimicrobials (MIA)

One Health and AMR

A One Health approach

The non-human use of antimicrobials in fact includes a broad range of species, beyond the historical focus on food-producing animals. These include aquaculture, companion animals, and fur-bearing animals. Reducing antimicrobial use in the non-human sector remains vital for preserving the efficacy of these substances, WHO said. 

Antimicrobial resistance (AMR) occurs when pathogens like bacteria, viruses, fungi, and parasites no longer respond to antimicrobial medicines, making infections harder to treat while increasing the risk of disease spread, severe illness, and death. Infections typically treated with routine medicines thus become life threatening. 

“Because AMR develops and transfers within and among all sectors, minimizing the risk of emergence and transmission of AMR  calls for a One Health approach,” WHO explained in the new guidance.

“To improve the responsible and prudent use of antimicrobial agents—and in particular medically important antimicrobial agents—it is thus essential to decrease their inappropriate use across sectors.”

Additionally, the report advocates for the more systematic inclusion of medically important antimicrobials in AMR monitoring and surveillance programs – which continue to be patchy and incomplete in most countries of the world.

New WHO category ‘for use in animals only’

In addition to the existing “highly important antimicrobials” (HIA) and “important antimicrobials” (IA) classifications, the WHO now includes an “authorized for use in animals only.” This group was added to “ensure that all antimicrobials used in animals come under scrutiny as part of the standard evaluation approach, so that they would not be placed in a low priority category by default, without proper assessment of the potential risk of AMR in humans.”

Image Credits: Photo by Myriam Zilles on Unsplash, Commons Wikimedia, WHO , WHO .

Closure of the Tenth FCTC COP: Head of the WHO FCTC Secretariat Dr Adriana Blanco Marquizo and COP10 President Zandile Dhlamini (Eswatini)

The Tenth Conference of Parties (COP10) of the WHO Framework Convention on Tobacco Control (WHO FCTC) sidestepped a controversial debate on e-cigarettes and heated tobacco products – effectively kicking the can on any decisions related to regulation of that swelling market to the next meeting in two years time.

However, the parties at the conference, the first face-to-face meeting in six years, agreed on a milestone decision strengthening language around Article 18, and “protection of the environment and the health of persons in respect of tobacco cultivation and manufacture.”

The parties also agreed to strengthen Article 19, which nations can use to hold the tobacco industry liable for its devastating impact on people’s health and the planet. The civil society group Corporate Accountability welcomed that measure as a “historic step forward to make Big Tobacco pay.”  And the COP adopted a “Panama Declaration” reaffirming the “fundamental and irreconcilable conflict” between the tobacco industry and public health.

Article 18 – historic moves on environmental protection

Dr Adriana Blanco Marquizo, Head of the WHO FCTC Secretariat, also described the new decision on Article 18 as “historic” – insofar as it expands and details the measures that countries should take to limit tobacco’s environmental harms.   

“The decision urges Parties to take account of the environmental impacts from the cultivation, manufacture, consumption and waste disposal of tobacco products, and to strengthen the implementation of this article, including through national policies related to tobacco and protection of the environment,” Blanco Marquizo said at a Saturday press conference concluding the week-long meeting.

“Globally, some 200 000 hectares of land are cleared every year for tobacco cultivation, accounting for up to 20% of the annual increase in greenhouse gasses (GHGs),” added WHO in a press release released on Sunday, just after the close of the week-long conference, although it failed to explain the source for the GHG estimate.

The new decision also addresses the issue of cigarette filters. An estimated 4.5 trillion cigarette butts are thrown away annually worldwide, representing 1.69 billion pounds of toxic trash- containing plastics. 

When exposed to sunlight and moisture cigarette filters break down into smaller plastic pieces, eventually leaching out some of the 7000 chemicals contained in a single cigarette. Many of those chemicals are environmentally toxic. “The decision on Article 18 is very timely given the ongoing intergovernmental negotiation committees working to develop an international legally binding instrument on plastic pollution, including in the marine environment,” stated WHO.

Delayed action on e-cigarettes and heated tobacco products

On the down side, action on new tobacco products that was expected to be one of the main conference outcomes was delayed – apparently under significant industry pressure.

Instead of a final agreement on a decision around e-cigarettes and heated tobacco products, the delegates agreed to create a working group to continue reviewing and revising the advice that would be produced until COP 11 in two years time. Industry has been pressing very hard on vapes as a way of reducing smoking harms.

Even though no common stance was agreed upon, countries can already take action based on existing FCTC resources and guidance, asserted Nuntavarn Vichit-Vadakan of Thailand, chair of a COP10 working committee addressing the issue. 

Those include ”Partial guidelines for implementing articles 9 and 10; an “information note on new and emerging tobacco products”; and a July 2023 report by the WHO FCTC Secretariat on the challenges posted by novel and emerging tobacco products. 

“The partial guidelines are ready for implementation by parties, only a few points are left unfinished,” Vichit-Vadakan said. But she expressed hope that the working group created at COP10 would make more progress on the regulation of new tobacco products over the coming two years, saying, “Each time we have decisions, we make one step forward to protecting the population.” 

Heated tobacco and e-cigarettes are soaring in popularity, especially among the young, even as the proportion of consumers of more traditional tobacco products like cigarettes has declined, from 33% of adults at the beginning of the century to 22% in 2023.

Big tobacco firms such as Philip Morris International, British American Tobacco and others have invested heavily in fighting regulation of the new products, promoting a narrative that frames them as a safer, cleaner alternative to traditional cigarettes, which support “tobacco harm reduction”. 

At the COP, a number of countries, led by Guatemala and including the Philippines, China, Russia, Antigua and Barbuda, echoed industry talking points that attempt to frame heated tobacco products and vapes as less risky than cigarettes, calling for more debate and research on the topic. This, critics say, will also delay implementation of lifesaving protections.

Member states at closing session of the Tenth Framework Convention Tobacco Control (COP10)

Panama declaration, against industry interference

Tobacco-aligned interest groups also organized a series of parallel events to the COP, attacking the Conference for an alleged lack of transparency and exclusion, ignoring the internal rules of the international treaty and its meetings, which establish safeguards to protect the conference of vested interests.

Industry representatives were also present during a daily debriefing organised by the Brazilian delegation, lobbying in favour of tobacco trade, reported the Global Alliance for Tobacco Control.

Despite those moves, the conference, saw far less interference than last December’s UN Climate Conference in Dubai (COP28), civil society advocates observed. 

“The talks were not inundated with corporate lobbyists like the most recent U.N. climate summit. The FCTC provides a strong example for how the UNFCCC and other international bodies can protect policy from corporate profit-seeking,” said Corporate Accountability.

Against that background, the adoption of the “Panama Declaration” was also a symbolic gesture of defiance. 

The Declaration refers to the “fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests,” Blanco Marquizo said, describing big tobacco as an “industry that profits from suffering and death.”

Meeting of Parties on illicit tobacco products

A smaller, four day Meeting of the Parties (MOP3) of February 12 to 15 follows the concluded conference. The 62 participating parties will look at progress in implementing the Protocol to Eliminate Illicit Trade in Tobacco Products.

FCTC’s implementation report found that since the last meeting of the MOP, over a half of the parties reported progress in tracking and tracing tobacco products (Article 8 of the Protocol), which makes smuggling more difficult.

Less has been achieved in terms of international collaboration, with respect to measures such as mutual legal, training and technical assistance or extradition of suspects of illegal trade in tobacco products.

Tobacco burden

Illegal or not, smoking is a major public health burden, killing over eight million people worldwide every year, according to the WHO. 

WHO Director General Dr Tedros Adhanom Ghebreyesus called tobacco “the biggest public health threats the world has ever faced” in his opening address at COP10.

“More than 20 years since it was adopted by the World Health Assembly, the WHO Framework Convention on Tobacco Control remains one of the world’s most powerful tools for health,” asserted Tedros. One study from Nature Medicine presented during the conference confirmed, for instance, that taxing tobacco products significantly reduces the number of people who become addicted.

“We are proud of the progress made by Parties during the tenth global tobacco treaty talks in the areas of liability against the tobacco industry and protecting the environment and human rights,” said Daniel Dorado, Corporate Accountability’s Campaign Director. “Now, we urge Parties to implement these measures at home to advance justice and make Big Tobacco pay for its harms to people and the planet in the next two years before Parties meet again in 2026.”

Image Credits: WHO/FCTC/Octoma.

Ethiopia, on behalf of the Africa group,  welcomed the special meeting to consider equity at the WGIHR

The working group negotiating amendments to the World Health Organization’s (WHO) International Health Regulations (WGIHR) has extended its seventh meeting, which was supposed to end last Friday, to include a special session on equity.

The resumed WGIHR 7 will be held within the first two weeks of March, finally acceding to member state’s requests – including from the Africa Group and the large alliance of countries known as the Equity Group – to give adequate attention to equity.

Unequal access to vaccines and other medical products during the COVID-19 pandemic was one of the triggers for the reform of the IHR, which are the rules setting out countries’ roles and responsibilities, and those of the WHO, during public health emergencies of international concern.

The resumed meeting will pay special attention to a new Article 13A, which addresses the availability and affordability of health products, technologies and know-how, according to a  year-old summary of the IHR negotiation text, which is the most recent public version of the negotiating text.

Article 44, dealing with collaboration and assistance, is another equity-related section that deals with building capacity to identify emerging public health threats, including through surveillance, research and development cooperation, and technological and information sharing.

The final key equity-related section is Annex 1, which relates to the core capacities needed by countries to improve their disease detection, surveillance and emergency response, including the assistance that developed countries can offer to developing countries to improve their capacity.

Ethiopia on behalf of the Africa group expressed its support for the equity-focused dedicated sessions to Articles 13 A and 44 A, describing it as “critical and important”.

“You all recall that this has been tabled prior for several months and we believe that these [articles] are at the heart of dealing with equity-related issues, which are part of the mandate of the IHR discussion,” said Ethiopia. 

Joint session planned with INB

During the reportback, WGIHR Co-chair Dr Ashley Bloomfield said that there would be a joint session between his group and the Intergovernmental Negotiating Body (INB), which is drawing up the pandemic accord, on 23 February.

That date is also the deadline for member states to provide written comment on the new text provided by the bureau during the meeting.

Bloomfield also pointed out that the resumed seventh meeting would take place after a two-week negotiating INB session, which begins on 19 February, and was likely to benefit from equity-related discussions during the INB.

“Our relationship with the INB process is strong and essential,” stressed Bloomfield.

The European Union’s representative stressed that the work of the WGIHR and the INB needed to be aligned.

“It is not that we are going to do this to do the same discussion or to address the same issues,one here and one there. This is not going to be possible nor efficient. There should be an understanding that there are a number of issues – sharing countermeasures, access to countermeasures, the financial issues writ large, some governance issues – that are entirely connected, and they cannot be addressed in isolation, otherwise, we will never solve them,” he stressed.

There was across-the-board appreciation for the role of the Bureau in facilitating the negotiations, particularly providing text in real time during the meeting for member states to consider.

Reality-check for negotiators

Dr Mike Ryan gives negotiators a reality check.

Dr Mike Ryan, the WHO’s executive director of health emergencies, gave negotiators a reality check at the end of the meeting.

“While you’ve been doing this, this week in the interest of the future health and workability of amended IHR, the elves have been in the basement processing 37,000 signals of potential epidemics, triaging 80 of those signals for follow-up member states, confirming 14 events around the world -circulating vaccine-derived polio, measles, Avian flu, Nipah, Chikungunya, [extensively drug-resistant] TB, diphtheria, swine flu, Orbivirus, Rift Valley Fever, Western Equine Encephalitis, yellow fever, SARS COV2 and the Lassa fever outbreak all happening in real time,” said Ryan.

The WHO has also carried out systematic rapid risk assessments under IHR, and published various alerts and disease outbreak news. 

“That’s the core of IHR. That’s what IHR is about, is working with our member states to increase that capability for the world to work together to detect, confirm, to share real time information about emerging events and ensure those events get collective response,” stressed Ryan.

“It’s a very precious process that has taken decades to develop,” he added. “What you’re discussing here may sometimes seem like word-smithing or not having necessarily an immediate impact on the world. It will because it will define the next 10 years of global surveillance and of collective security when it comes to health emergencies and particularly high impact epidemics. 

“This is a collective process. It provides a safety net, it provides protection for all our communities. You’ve treated this process with tremendous care and professionalism. I just would urge you again as the Director General has: get this done by May and give us back the IHR in better shape than it’s ever been and we will be forever grateful.”

Girls and women in Pakistan receiving hepatitis prevention education – more outreach and action in communities is needed.

Approximately 10 million Pakistanis are living with hepatitis C (HCV) with three people dying of HCV- related causes every minute – and this in the case of a disease that is now largely curable with treatment. 

Hepatitis B Virus (HBV) also poses major public health burden on the country’s health system with an estimated 4 million active infections in the population. Transmission is largely driven by infections acquired from healthcare settings, which puts the wider population at risk.

Altogether, it’s estimated that more than 20,000 people a year die in Pakistan from hepatitis-related causes. 

WHO’s strategy for Elimination of Hepatitis refers to a 90% reduction in new HBV infections and a 75% reduction in new HCV infections by 2030 over the 2020 baseline, and a 65% reduction in overall mortality.  The Sustainable Development Goals (Target 3.3) meanwhile, call for “combating hepatitis” by 2030.

Great strides could be made towards these WHO and SDG goals with the uptake of new  strategies for bringing hepatitis diagnosis and treatment to the primary and district care levels. This also would save families the heavy  burden, and public hospitals the high-costs, of later stage treatment. 

Heptatis C prevalence in Pakistan

Hepatitis isn’t treated as a priority disease 

Pakistan, a range of health systems challenges have contributed to sluggish progress towards disease elimination to date. 

First and foremost, due to lack of effective and strategic advocacy, hepatitis does not get much attention from policy and decision makers. This is reflected in the resources being directed towards the programs of competing priorities. The primary diseases of public health focus remain dengue, polio and tuberculosis – which in fact account for far fewer deaths when compared to hepatitis B and C.

As a result, there is little incentive to expand public health hepatitis services, leading to disparity in demand and supply of hepatitis screening, vaccination, and treatment services – treatment that can lead to cure for those living with HCV. Additionally, private treatment remains expensive and out of reach for the majority of the country’s population.

Lack of access to diagnosis and care services 



Provincial hepatitis control programs exist but there is a large variability in successful program implementation across Pakistan’s provinces. 

The infrastructure of provincial hepatitis programs is centralized and mostly limited to hepatitis clinics that are located at tertiary healthcare facilities, i.e. hospitals. 

The access to preventive, diagnostic and treatment services for impoverished and marginalized communities that are at the highest risk is more difficult. Even for those who manage to access the central healthcare system, the pathway from screening to treatment acquisition is hard to navigate and time consuming.

Notably, a PCR assessment of viral load remains the standard for a confirmed diagnosis, and this only available through a limited number of labs. Provincial hepatitis programmes must bear the cost of transportation and quality management of samples, along with testing people with suspected cases. For a patient, the process from tet to results can take days and sometimes weeks. This system consumes the resources in ineffective way.

Public hospitals saddled with high costs of acute disease treatment

The shortcomings of the hepatitis control programs are reflected in the consequently  high burden of liver disease and costs associated with treating ‘decompensated liver disease’, where acute symptoms develop, as well as liver failure and liver cancer, in tertiary care hospitals.

This requires resources to be spent on specialized gastroenterology and hepatology healthcare. In addition, the patients must bear out-of-pocket costs for expensive CT scans, tests of  tumor markers, etc..  This imposes a significant financial toll on families, who therefore are likely to end up in government hospitals due to lack of affordability.

Needed – large scale decentralization and door-to-door models 

Pakistan’s Punjab province had undertaken a model of decentralised care for hepatitis.

To combat hepatitis in Pakistan, a program overhaul is therefore needed – so as to bridge the existing gap between public health and clinical medicine. This involves drafting a comprehensive national action plan that holistically addresses all components of the disease epidemiology, as well as harnessing available resources, and implementation science more effectively.

The action plan must provide for the large-scale decentralization of hepatitis care alongside a pattern of ‘differentiated’ service delivery.  This means establishing structures allowing people to be treated in community primary facilities and district-level secondary facilities at earlier stages of infection and disease – with more  complicated cases referred to hospitals for more complex tertiary care.

For communities with a high burden of infection, small scale micro-elimination programs using a door-to-door elimination model can be implemented. This also requires agreement to an effective, ‘needs-based’ utilization of resources,  with some sharing of commodities and human resources, from other successfully running programs at district level.

Combating under-diagnosis

Punjab province, Pakistan

Along with that, establishing a strong, hierarchal surveillance system for HBV and HCV infections is the need of the hour. 

Underdiagnosis of hepatitis is a barrier to elimination. But this can be addressed with the use of new and innovative surveillance tools and technologies to generate quality data and support  evidence-based decision making.

Strategic advocacy and communication must be included in the action plan to improve risk perception and community health literacy about bloodborne infections.

And most important of all, end user involvement in drafting the national plan is a must with the feedback from primary care providers and frontline health workers to tailor the program based on community needs.

On World Hepatitis Day 2019,  the national government announced a PKR 35 billion ($125 million) investment in hepatitis control, launching a National Hepatitis Elimination initiative.   The plan aims to screen up to 140 million people and expand treatment to those infected.  

It’s still far too little to cure the millions living with hepatitis. But it remains a beginning, showing high-level political commitment. But pledges alone are not sufficient. The dire need is to make hepatitis elimination a national priority with a strategic shift in governance and policy and ensuring the intelligent expenditure of resources.

Dr. Nida Ali

Dr Nida Ali is a fellow with the Coalition for Global Hepatitis Elimination, a program of the Task Force for Global Health. The Coalition pursues worldwide elimination of viral hepatitis by strengthening local capacity and bringing together global partners to share knowledge and experiences related to prevention, testing, and care and treatment. 

 

Image Credits: The Hepatitis Fund, Indus Health Network , End Hepatitis, End Hepatitis , Nida Ali.

Dozens of white tents stand outside Türkiye’s Gaziantep train station housing Turks and Syrian refugees, shortly after the February 6 2023 earthquake.

One year after a 7.8 magnitude earthquake wracked Türkiye and Syria, some 690,000 people  remain displaced in southern Türkiye, out of the 3 million people that initially lost their homes  when the natural disaster hit in the early morning of 6 February 2023.   

Another 40,000 Syrians remain internally displaced mainly in the northern region of the country.  

At the same time, the number of Syrians requiring humanitarian assistance has increased from 15.3 to 16.7 million people as the challenges of internal displacement related to years of civil war, food insecurity, and economic crises compound disaster recovery. 

“Thousands are still homeless and vulnerable,” said Shabina Mantoo, a spokesperson for the United Nations High Commission on Refugees (UNHCR). And 40,000 [Syrians] still reside in temporary facilities,” she said, speaking at a Geneva press conference earlier this week where UN agencies renewed their appeals for donors to support earthquake reconstruction.  

The earthquake that struck southern Türkiye and northwestern Syria, killed 59,000 people as well as causing widespread damage to infrastructure. A series of aftershocks as well as freezing temperatures further complicated rescue efforts for the tens of thousands injured. 

The disaster was one the region’s deadliest in recent times, with years of civil war and conflict compounding Syria’s efforts to recover.  Turkiye, meanwhile, continues to host 3.7 million Syrian refugees from years of civil war, compounding its own efforts to recover as well, said Mantoo.  

A family from Lattakia in northwestern Syria, stands near their destroyed house shortly after a devastating earthquake hit their city on Feb. 6, 2023

Aid to Syria dwindles

In the weeks immediately following the disaster, United Nations agencies raised some $387 million in pledges for basic humanitarian and health supplies, as well as reconstruction of some 48 damaged healthcare facilities in northwestern Syria. 

But in the months that have since followed, global attention and funding has shifted to other conflict zones and areas, such as the civil war raging in Sudan and Israel’s war with Hamas in Gaza.  

While Türkiye’s government has undertaken programs of national reconstruction, recently unveiling rebuilt homes and medical buildings in the earthquake’s epicenter of Kahramanmaraş province, much of Syria’s displaced population continues to reside in temporary camps, supported by international aid agencies and donors.

“We don’t have funding to even think of going into larger scale rehabilitation and reconstruction,” said Mads Brinch Hansen, head of the International Federation of the Red Cross delegation to Syria, speaking at the Geneva press conference. 

United Nations High Commissioner for Refugees spokesperson Shabina Mantoo at a UN press conference in Geneva on the one-year anniversary of the earthquake.

WHO appeal for emergency funding

Last month, WHO issued a flash appeal for another $1.5 billion in aid to nearly a dozen Grade 3 humanitarian emergencies raging in the Eastern Mediterranean Region and Africa, including for $80 million for Syria. 

On Tuesday, the global health agency warned that funding shortages could threaten WHO’s work in northwest Syria, potentially disrupting direct health aid to two million people. 

“On 6 February, it will be one year since a series of devastating earthquakes hit southern Türkiye and northern Syria, killing 50 000 people in Türkiye and 5900 in Syria. Tens of thousands more people were injured, and thousands of homes and public buildings, including hospitals, were damaged or destroyed.  This was one of the biggest disasters in the region in recent times,” the agency noted. 

“In Syria, the earthquakes hit communities that had already been deeply affected during the 13-year long conflict-driven crisis.” 

WHO underlined the role the agency is still playing in supporting Syria’s recovery, including: delivery of health supplies; strengthening disease surveillance and outbreak response; and addressing the mental health and psychosocial needs of the affected populations. 

Image Credits: Abdulsalam Jarroud/TNH, @UNICEF/UN0779766/Belal.

Activists protesting against medicine patents

 Evergreening patents on medical products – extending the lifespan of patents that are about to expire – is an “abuse of the intellectual property system”, an HIV activist told the World Health Organization’s (WHO) Fair Pricing Forum on Thursday.

Meanwhile, an industry representative laid out her company’s value-based, country-specific approach to improving access to medicines, providing an example of how it had improved access to cancer medicine in Nigeria.

Ukraine-based Sergiy Kondratyuk, who works for the International Treatment Preparedness Coalition, said that evergreening is pervasive and a barrier to lower medicine prices.

“In Thailand, about 70-80% of drug patents are evergreened … and approximately 45% were evergreened Ukraine,” said Kondratyuk.

He urged people to oppose this practice – using a technical “patent opposition” process. This was used successfully in India after an international campaign resulted in the Indian Patent Office declining Johnson & Johnson’s application to prolong its patent for the TB drug, bedaquiline, which it had held for eight years.

“After that J&J started very active negotiations on voluntary licence and on eventually announced non-law enforcement of all evergreening patents on bedaquiline in almost all low and middle income countries, so this was an important result,” said Kondratyuk.

Earlier in the forum, Adrian van den Hoven, chair of the International Generic and Biosimilar Medicines Association (IGBA), which aims to foster market access for generic medicines, said that the evergreening of patent agreements “artificially stretches monopolies and harms access to medicines”.

Value-based approach to medicine pricing

Roche vice-president Tamara Schudel told the forum that her company recognised that “our medicines are only effective if they can reach the patients who need them. 

“This is why we’re constantly looking for ways to support patient access in low and middle income countries in particular,” she added.

“We take a value-based approach that reflects the benefits the medicine delivers to the patients, their families, the health care systems and society as a whole,” said Schudel. “Then we look at the context of the health care system in which we’re operating.”

Roche also uses tiered pricing where it charges lower prices in low income countries than in higher income countries. 

“We also recognise that there are unique health care needs and affordability challenges in low and middle income countries,” she added.“We have found that by working closely with the local payers and governments and health systems, we can find flexible and tailored solutions that can effectively address the broader health care and economic barriers that stand in the way of access.”

She gave the example of Roche’s work in Nigeria.“In Nigeria in 2020 there were approximately 125,000 new cases of cancer. Since fewer than 10% of Nigerians were insured, there was a significant delay in seeking cancer care due to the fear of additional financial burden.

There was also no health insurance coverage for innovative cancer medicines, which created additional significant access barriers. 

Screening for breast cancer in Nigeria

“We worked with the National Health Insurance Authority and the government to enter into a memorandum of understanding for a new insurance model. While this cost-sharing model has just recently started, there’s already been an impact with more people presenting for screening and treatment earlier,” said Schudel.

“With cancer, the earlier you catch it, the better the outcomes and the farther your investment goes. So this will serve better outcomes not only for patients, but the community more broadly.”

She described Roche’s “collaborative approach to overcome country-specific barriers to access, and working together to create conditions to support differential pricing and implementation of innovative access pricing and payment models tailored to the unique socioeconomic conditions and health care needs of the country” is the best route to support greater affordability and improved access. 

“We welcome solution-oriented dialogues between industry, WHO member states, and health care system stakeholders,” she concluded.

Roche vice president Tamara Schudel (bottom right) told the Fair Pricing Forum about her company’s work with cancer patients in Nigeria.

Intellectual property for public good

Mustaqeem de Gama, director of legal international trade at Afrigen, the South African company that is running the WHO mRNA hub, said that intellectual property (IP) policies should aim to improve public health.

“These are private rights which should be subject to public rights with health as a public good,” said De Gama. “The pendulum has swayed too much the one way, with private rights holding sway over public concerns.

The system needs to change to ensure appropriate tech transfer, know-how and finances to safeguard health – particularly in a pandemic, he added.

“That is why there is a review of the International Health Regulations and a pandemic treaty negotiations. There has to be democracy in how decisions are made.”

Industry needs incentives to share patented products

Charles Gore, executive director of the Medicines Patent Pool (MPP), spoke earlier at the forum about the need to make a business proposition for companies to share their innovative products. The MPP encourages companies to issue voluntary licences for medical products to “increase access to and facilitate the development of life-saving medicines for low- and middle-income countries”.

Medigen Vaccine Biologics was the only commercial company to share its COVID-19 vaccine with the World Health Organization’s (WHO) – but only in 2023.

COVID-19 Technology Access Pool (C-TAP). C-TAP was established to encourage the developers of COVID-19 therapeutics, diagnostics and vaccines to share their intellectual property, knowledge, and data with quality-assured manufacturers through “public health-driven, transparent, voluntary, non-exclusive and transparent licences”.

“If the neighbourhood is on fire, you try to stop the fire at your own house before you start helping others. But if you don’t help others, the fire might jump back into your house,” says Paul Fure Torkehagen, the company’s vice-president.

“We were selected to be part of Solidarity trials, and made a promise to have affordable and equitable access to our vaccine. We were also funded by Sanofi in a co-sponsored clinical study so we made promises in that regard,” he explains.

But the C-TAP experience has its advantages for innovation. Under usual circumstances, a company can only draw on its internal resources for innovation, but with an open innovation platform, “you can leverage both internal and external ideas and technology bases”,  and “leverage external collaborators but also open up alternative markets”, said Torkehagen.

“In the next pandemic, we might not have the technology and so we have to lead by example in hopes that, in the future pandemic, we can obtain technology from others.”

Nonetheless, Torkehagen says that there have to be commercial opportunities to incentivise companies to share their innovations.

He also warned policy-makers that when they insert themselves between the holder of patents and the receiver of this – as the WHO did in C-TAP – “you want to incentivise and increase the efficiency and speed at which the technology goes to the receiver, not create barriers in that process”.

Image Credits: Roche.

Global access to medicine is being hampered by secrecy in procurement, argue civil society groups

Over 50 civil society groups have written to the leaders of the world’s biggest medicine procurement programmes urging them to reject “secrecy clauses” in their agreements with pharmaceutical companies. 

The letter, which has been shared exclusively with Health Policy Watch, was sent to the heads of UNICEF, the Pan American Health Organization (PAHO), vaccine alliance Gavi, The Global Fund to Fights AIDS, Tuberculosis and Malaria and the US President’s Emergency Plan for AIDS Relief (PEPFAR) on Tuesday.

The civil society groups, which include the People’s Vaccine Alliance, Public Citizen, Health GAP and a multitude of local patient advocacy groups, express “deep concern about the increasing use of confidentiality and non-disclosure clauses” in contracts between drug manufacturers and government, multi-stakeholder and humanitarian buyers.

They appeal to the big five procurement agencies to use their buying power to reject secrecy clauses that are hindering “equitable access to essential medicines by making it harder to establish fair terms, reasonable prices, and timely supply”. 

In 2021, the United Nations system alone spent $10.6 billion on medical products.

UNICEF’s global supply hub in Copenhagen ships vaccines and medical products worldwide.

COVID-19 stoked secrecy

“Secrecy imposed by private industry across the entire value chain of medical products became the norm during the COVID-19 pandemic. There was secrecy with respect to many publicly funded R&D agreements and an absence of terms and conditions requiring transparency of research outcomes and conditions on commercialization,” they write.

Companies claim “trade secret protection” in relation to a range of issues including public investments and incentives in the research and development of new drugs; prices and pricing policy; procurement agreements and supply commitments. 

“Regrettably, PEPFAR has recently sidestepped transparency obligations by allowing its contracted bio-pharmaceutical distributor, Chemonics, to sign a non-disclosure agreement with ViiV,” the letter notes.

Contract transparency is a key issue in the current pandemic accord negotiations, and the current draft negotiating text includes transparency as a core principle, but does not include any legally binding provisions.

Activists in Spain and Colombia have taken legal action to establish “the principle that drug prices are not protected trade secrets”, according to the letter.

Meanwhile the Health Justice Initiative in South Africa secured a court order compelling the government to make full disclosure of its procurement agreements with Johnson & Johnson, Pfizer, Serum Institute, and Gavi’s COVAX program during the COVID-19 pandemic.

It emerged that Johnson & Johnson (J&J) and the Serum Institute of India (SII) charged the South African government more than the European Union for COVID-19 vaccines – and South Africa assumed all the risk in ‘take-it-or-leave-it’ contracts with Pfizer, J&J and SII. 

Lack of transparency enables corruption

Fair Pricing Forum plenary on transparency.

Interestingly, at the World Health Organization’s (WHO) Fair Pricing Forum on Wednesday ,South Africa’s Deputy Director General of Health, Dr Anban Pillay, said that pharmaceutical companies had taken advantage of COVID-19 to secure high prices for vaccines from his government.

Addressing the morning plenary on drug price transparency, Pillay also paid tribute to civil society organisations for their advocacy on access to affordable medicines.

Meanwhile, Dr Yupadee Sirisinsuk, Thailand’s Deputy Secretary-General of Health Security, called for international regulations to make sharing of medicine prices compulsory.

Billy Mweetwa, former Director General of the Zambia Medicines and Medical Supplies Agency, told the plenary that the lack of transparency in medicine procurement weakened governments’ negotiating power as they “have no price benchmarks”, and could also lead to corruption in the negotiations.

Sabine Vogler, head of the pharmacoeconomics at the Austrian National Public Health Institute, described payers as entering negotiations “blindfolded” as they had no idea what others were paying. 

New transparency policies 

Charles Gore, executive director of the Medicines Patent Pool, said that where governments provided public funds for R&D, there were often clauses related to product access “but governments then don’t actually enforce them”. 

“COVID really highlighted the lack of enforcement of access rights,” said Gore.

International agencies could be “important advocates” of pooled procurement to drive down costs, he added.

However, the civil society groups want far more in their letter to the “Big Five”.

“We believe it is time for the largest procurers of medical products, including UNICEF, PAHO, Global Fund, PEPFAR and Gavi, to act individually to adopt new transparency policies and collectively to support the adoption and enforcement of a new common standard that rejects secrecy, and that supports more robust, accessible reporting of procurement contract terms and agreements,” they argue.

“Similarly, governments should reject coercive non-disclosure agreements, and simultaneously they should clarify or modify their freedom of information and drug procurement laws to ensure that supply, price, and distribution terms are publicly available,” they conclude, saying that they were ready to engage on the issue with the agencies.

‘Unintended consequences’ of transparency

However, Richard Torbett, head of the Association of the British Pharmaceutical Industry, said that “sometimes the sharing of information is really helpful and sometimes the sharing of information can have some unintended consequences”.

Industry needs incentives to create the best medical products for patients, said Torbett.

“Pharmaceutical prices need to be scrutinised, but I’m much happier about pharma companies being scrutinised on clinical data on how well their products work for patients, rather than an accounting debate about how to portion R&D costs,” he added.

Torbett said that while transparency was important, particularly in regard to “multi-source products, where that transparency can drive better competition, lower prices, and I would hope that translates into better access around the world”.

But he was sceptical that price transparency about new medicines would drive prices down: “It’s not that the industry is against transparency for the sake of it. It’s a real sense that, through international reference pricing and some of the consequences of that, there is a belief that transparency of net prices could lead to price convergence, and that price convergence ultimately is likely to be detrimental to the poorest countries in the world.”

Torbett also noted that “countries want to strengthen their negotiating position by understanding the prices charged elsewhere. I’d be very interested to know whether some of those countries would be willing to share their own prices.”

Frustration at being disempowered

Concluding the forum’s plenary on transparency, Dr Suerie Moon, co-director of the Global Health Centre at the Geneva Graduate Institute, said she sensed “frustration in the room” was disheartened about the “circular discussion” from one forum to the next.

“On the part of payers, there is frustration at being disempowered by information asymmetry and a strong desire to have more transparency, not only in order to negotiate fair prices, but also to be more accountable to the public and to address the risk of corruption,” said Moon.

Countries had also felt frustrated when trying to act alone, said Moon.

“There’s a very strong role for international cooperation and coordination, whether that is through information sharing, joint negotiations, training or pooled procurement.”

Image Credits: Jernej Furman/Flickr, Prachatai.

The high price of medicines in many high- and middle-income countries and ensuring medical supply chains during crises were  some of the issues discussed at the Fair Pricing Forum, which opened on Monday.

The three-day forum, hosted by the World Health Organization’s (WHO), brings member states and stakeholders together to  discuss how to ensure “optimal access to affordable health products”.

Judit Rius Sanjuan, director of the Pan-American Health Organization’s (PAHO) access to medicines department, told the opening plenary that the problem of access to medicines seems to be of “system design and therefore correctable”.

COVID-19 had a “devastating impact” on Latin America and the Caribbean, said Sanjuan.“Even though it is just 8.4% of the world’s population, it accounted for over 20% of global infections and 32% of deaths.”

The lack of equitable access to vaccines, shortages and overall lack of access to other medical tools including diagnostics and personal protective equipment (PPE), contributed to these statistics.

“The region is experiencing an epidemic of lack of access to high-cost technologies, or as we may dare to say, high-priced technologies,” said Sanjuan.

Judit Rius Sanjuan, director of the Pan-American Health Organization’s (PAHO) access to medicines department.

“The annual growth in pharmaceutical spending in Latin America and the Caribbean is 12% – four times more than in North America and six times the rate of Europe,” she said, adding that a recent study showed that some Latin American countries paid more for cancer drugs than many European countries.

Eight countries – Argentina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Uruguay and Venezuela – spend $3.2 billion every year on biological products including monoclonal antibodies.

In addition, over 1000 products in the US – also part of PAHO – had above inflation price increases in 2021, with the average increase being 31%.

Litigation as path to medicine access

“Due to the high cost of medicines, litigation has become a common pathway [for patients] to get access. In no other region is this trend as strong as in Latin America and the Caribbean. In just a decade, the number of health access litigation cases increased by 130% in Brazil and 119% in Colombia,” said Sanjuan.

“Most Latin American countries have to self-finance because they are not eligible for global financing. The current criteria for access and the pricing structure do not correspond with the needs of the region, where most countries are middle-income countries and some are high-income.”

For example, she said, hepatitis treatment costs $3000 in some countries in the region while the same treatment costs $200 in low-income countries.

“We shouldn’t punish economic development and progress with higher prices, especially as we are hurting, not only the health system, but the population in need. On average, households spend 34% of medical spending on medicines and out-of-pocket spending can be up to 60% in some countries, with the poorest people spending the biggest proportion of income on medicine.”

PAHO’s response to high prices include pooled procurement, increased regional production especially of high price technologies and expanded investment in vaccine and medicine research an development (R&D), Sanjuan concluded.

Antiretroviral price cut show what can be done

Meanwhile, Ellen ‘t Hoen, director of Medicines Law and Policy in the Netherlands, used the reduction in the price of antiretroviral (ARV) medicine for HIV treatment as an example of what could be done to bring down prices.

Initially costing $10-$15,000 per year although their production cost was “modest”, prices fell by 90% in the early 2000s once generic manufacturers entered the market, said ‘t Hoen.

“The following elements made this happen and I want to list those because they’re still very relevant today,” she added.

“First of all, the HIV medicines were added to the WHO Essential Medicines List despite their price. WHO pre-qualification was established and assured quality and the confidence in the [generic] products. As of 2003 , funding became available from the Global Fund, PEPFAR, other sources such as Unitaid,” said ‘t Hoen.

Additional factors include “extensive use of TRIPS flexibilities” after the World Trade Organisation adopted the Doha Declaration on TRIPS and public health in 2001. 

“And finally, there was transparency. The prices paid for these antiretroviral drugs were collected and made public almost in real time. As a result today, the Global Fund procures the three-in-one fixed dose combination for HIV treatment for under $40 per year.”

The high cost of cancer medicine, and the Medicines Patent Pool’s inability to secure licensing opportunities for oncology products – bar on one drug that was about to expire – “has to change”, she added.

“High medicines prices are sustained through monopolies, which are granted through both the patent system and the medicines regulatory system. Without addressing monopolies in medicine supply, it will remain difficult to reach fair pricing levels, in particular for newer medicines,” concluded ‘t Hoen, adding that it was unclear whether countries would address barriers before the next pandemic.

Voluntary licensing

However, Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said that the best way to secure better access to medicines was via voluntary licensing agreements.

He added that the IFPMA supported more geographic diversity in manufacturing and wanted to have proposals in their Berlin Declaration embodied in the pandemic accord currently being negotiated at the WHO.

Adrian van den Hoven, chair of the International Generic and Biosimilar Medicines Association (IGBA), which aims to foster market access for generic medicines, said that the evergreening of patent agreements artificially stretches monopolies and harms access to medicines.

The negative impact of IP ‘evergreening’.

His association provides 70-90% of all prescription medication worldwide, said Van den Hoven. 

Key barriers to global access were related to regulation, intellectual property rules and sustainable off-patent markets to prevent medicine shortages.

Ensuring medicine in crises

Sierra Leone’s Deputy Minister of Health, Dr Charles Senessie, said that his country had to apply “out of the box thinking” to safeguard its medical supply chain during both conflict and health emergencies, such as the Ebola outbreak.

“We have developed a mobile app to monitor the supply chain even when there is no power,” said Senessie. “We also have protocols in place to ensure that services keep running in conflicts.”

Sierra Leone has turned to solar energy to power health facilities and is using hybrid vehicles to save fuel.

The Fair Pricing Forum ends on Thursday.

Dr Charles Senessie, deputy health minister of Sierra Leone.