The global organizations and populists who aim to seize COVID vaccine tech and IP

When Donald Trump claimed in September 2020 that every American would have access to vaccines by April 2021, his comments received scorn. The Washington Post said his claims were “without evidence,” CNN quoted health experts who said it was impossible, and The New York Times claimed it would take another decade.

Now, a year into this pandemic, nearly half of the eligible population has received at least one vaccine dose in the U.S., and distribution has been opened to every American adult.

Operation Warp Speed, which invested tax dollars and helped reduce bureaucracy across the board, has contributed to what has truly been a miraculous effort by vaccine firms.

While Trump’s proclamations eventually become true and the question of vaccine ability has been settled, there is now pressure on the Biden administration to turn over domestic vaccine supply to countries with skyrocketing cases.

On Sunday, the U.S. declared it will send additional medical supplies to India, currently experiencing the largest global spike in cases.

But at international bodies, countries and activist groups are petitioning for far more: they want to force biotech companies to waive intellectual property rights on vaccines and COVID-related medical technology.

Along with nearly 100 other countries, India and South Africa are the architects of a motion at the World Trade Organization called a TRIPS Waiver (Trade-Related Aspects of Intellectual Property Rights).

If the waiver is triggered, it would ostensibly nullify IP protections on COVID vaccines, allowing other countries to copy the formulas developed by private vaccine firms to inoculate their populations and play into the hands of future governments more hostile to private innovation.

This week, U.S. Trade Representative Katherine Tai met with the heads of the various vaccine makers to discuss the proposal, but it is uncertain if the Biden administration will support the measure at the WTO.

While many companies have voluntarily pledged to sell them at cost or even offered to share information with other firms, this measure would have more far-reaching implications.

This coalition seeking the TRIPS waiver includes Doctors Without Borders, Human Rights Watch, and World Health Organization Secretary-General Tedros Adhanom Ghebreyesus, who first backed this effort in 2020 before any coronavirus vaccine was approved.

They claim that because COVID represents such a global threat and because western governments have poured billions in securing and helping produce vaccines, low and middle-income countries should be relieved of the burden of purchasing them.

Considering the specialized knowledge needed to develop these vaccines and the cold storage infrastructure required to distribute them, it seems implausible that any of this could be achieved outside the traditional procurement contracts we’ve seen in the European Union and the U.S.

That said, rather than celebrating the momentous innovation that has led to nearly a dozen globally-approved vaccines to fight a deadly pandemic in record time, these groups are trumpeting a populist message that pits so-called “rich” countries against poor ones.

Intellectual property rights are protections that help foster innovation and provide legal certainty to innovators so that they can profit from and fund their efforts. A weakening of IP rules would actively hurt the most vulnerable who depend on innovative medicines and vaccines.

If the cost of researching and producing a COVID vaccine is truly $1 billion as is claimed, with no guarantee of success, there are relatively few biotechnology or pharmaceutical companies that can stomach that cost.

BioNTech, the German company headed by the husband-wife team of Uğur Şahin and Özlem Türeci that partnered with Pfizer for trials and distribution of their mRNA vaccine, was originally founded to use mRNA to cure cancer.

Before the pandemic, they took on massive debt and scrambled to fund their research. Once the pandemic began, they pivoted their operations and produced one of the first mRNA COVID vaccines, which hundreds of millions of people have received.

With billions in sales to governments and millions in direct private investment, we can expect the now-flourishing BioNTech to be at the forefront of mRNA cancer research, which could give us a cure. The same is true of the many orphan and rare diseases that do not otherwise receive major funding.

Would this have been possible without intellectual property protections?

Moderna, for its part, has stated it will not enforce the IP rights on its mRNA vaccine and will hand over any research to those who can scale up production. The developers of the Oxford-AstraZeneca vaccine have pledged to sell it at cost until the pandemic is over.

While this should smash the narrative presented by the populists and international organizations who wish to obliterate IP rights, instead they have doubled down, stating that these companies should hand over all research and development to countries that need them.

If we want to be able to confront and end this pandemic, we will continue to need innovation from both the vaccine makers and producers who make this possible. Granting a one-time waiver will create a precedent of nullifying IP rights for a host of other medicines, which would greatly endanger future innovation and millions of potential patients.

Especially in the face of morphing COVID variants, we need all incentives on the table to protect us against the next phase of the virus. 

Rather than seeking to tear them down those who have performed the miracle of quick, cheap, and effective vaccines, we should continue supporting their innovations by defending their intellectual property rights.

Yaël Ossowski (@YaelOss) is deputy director of the Consumer Choice Center, a global consumer advocacy group.

The Commission’s great U-Turn on mRNA vaccines

Here’s a change of heart we can support…

Back in January I published a blog post on this site asking the question of whether the new generation of COVID-19 vaccines will change our view on genetic engineering. In a statement back in July last year, the European Parliament said that “The derogation will facilitate the development, authorisation and consequently availability of COVID-19 vaccines and treatments”. According to EU legislation dating back to the early 2000s, genetic engineering is generally forbidden, with only a few exceptions. This was particularly driven by the scepticism of genetic engineering in agriculture. The Pfizer/Biontech, which to date remains the most prominent and incidentally most trusted COVID-19, something that surveys have also shown with our friends in the United States.

Now, the Commission is surfing the wave of the popularity of this vaccine in order to bank on mRNA shots for fighting COVID-19. And, as Euractiv reports, more voices are supportive of these vaccines in the fight against future pandemics: “Commenting on the news, centre-right MEP Peter Liese said he supported the decision to move towards mRNA vaccines, pointing out that they can be better adapted to mutations.”

Peter Liese is to be commended for his statement on this matter. Indeed, this new technology which relies on genetic engineering is very promising. For some experts, mRNA vaccines hold the key to faster and more effective vaccine programmes, capable of fighting multiple viruses in a single injection or providing protection against recalcitrant diseases (diseases characterised by poor survival and with little progress made in developing novel treatments).

In January, Moderna launched new programmes to develop mRNA vaccines for Nipah virus, HIV and influenza, adding to its portfolio of 20 mRNA candidates. Pfizer is also developing new mRNA vaccines, including one for seasonal flu. Several dozen other manufacturers and laboratories around the world are currently involved in similar initiatives.

The use of mRNA as a therapeutic or vaccine technique has been studied and developed for over a decade. Its interest seems to go beyond the field of vaccines against infectious diseases and also concerns cancers (see, for example, the immunotherapy products under development at BioNTech, or diseases with an autoimmune component (a treatment against multiple sclerosis is under development at BioNTech).

COVID-19 will have accelerated the large-scale evaluation of mRNA technologies. It is likely that this approach will expand massively in the coming years, also benefiting from advances in microencapsulation (nanoparticle) technologies. This technology could be refined by allowing nanoparticles to target specific cells by adding specific recognition molecules (e.g. ligands, receptors, antibodies) to the particle membrane. It will then be possible to deliver mRNA only to cells that need it (e.g. to compensate for the absence of a protein in genetic diseases, as with gene therapy, or to eliminate infected or tumour cells).

However, for this to happen the European Union ought to change its general approach to genetic engineering. While the support for the Pfizer/Biontech vaccine is commendable, more needs to be done from the point of view of legislation. There is a significant logical discrepancy when we are ready to use genetic engineering for medical purposes, but we somehow reject it in the field of agriculture. There are comparable health benefits to using similar technologies in our food; not least since the invention of vitamin B-heavy Golden Rice for the Asian market have genetically modified foods shown to be inherently linked to healthier food. On top of that, we can achieve our climate ambitions through new technologies that consume less resources at higher yields.

Originally published here.

Germany’s Vaccine Drive Problems

Fred Roeder went on TalkRadio’s Mark Dolan Show to discuss the shortcomings of the German Government around the COVID19 vaccine procurement.

Originally published here.

Finding innovative ways to improve European health

Some of the answers are in front of us…

When one of the Consumer Choice Center’s policy fellows, Nur Baysal recently published a blog post on senolytics on this page, I started to wonder about other alternative ways to improve health. COVID-19 has had many people take up worse habits in their daily lives, while others have used their spare time to pursue healthier diets and exercise routines.

Meanwhile, the European Union is following old adages in their pursuit of making the continent live longer. Sugar taxes are quickly approved and supported by the European Commission, tobacco control rules are applauded, and alcohol is targeted by new measures. The EU’s Beating Cancer Plan even eyes vaping as a threat to public health, which has very little support from the scientific community, but unfortunately, evidence-based policy-making is not integrated too much into the hearts of the Berlaymont building in Brussels. 

Their responses are stale and old-fashioned, while the world keeps turning and innovating. Senolytics is a high-tech approach to prevent ageing, but some of our older household goods lying around turn out to be comparably helpful to improve our health. 

To turn to a personal story: two years ago, I underwent surgery to remove my tonsils and to fix a disfiguration in my nose that had bothered me for years. Both surgeries went poorly, which led to a much longer recuperation time. I faced long and painful days in the hospital that I was only able to deal with due to a large amount of anti-inflammatory medications and painkillers. I have since gotten better, but a lasting effect of the drugs I’ve been giving is a more sensitive stomach. With constant acidic reflux, I need to be more careful about what I eat and reduce my stress levels not to worsen it—avoiding snacking as a part of this effort.

I’ve since discovered that chewing has had positive effects on avoiding some of the sugary alternatives that cause my stomach upsets. With sugar-free gum, I’m able to keep my mind off of the sugary or salty snacks in the kitchen. This 2011 study found that chewing gum reduces the desire for snacks by 10%, which makes a significant dent in my afternoon cravings for those foods that are unhealthy. On top of that, it improves my ability to focus, which is particularly useful during long Zoom call mornings or proofreading afternoons.

Chewing gum contains xylitol, a chemical compound categorised as “sugar alcohol”. It has fewer calories than sugar and does not raise blood sugar levels. On top of that, daily chewing xylitol gum reduces biofilm formation by 42%, which reduces bacteria in the mouth. Thus, chewing gum has become a kind of wellness routine, freeing me from craving crisps or downing a third espresso.

My friends around me have taken different routes. A mix of meat-only diets and cycling seems to work for one of my good friends, while my father has completely given up on meat but taken up an impressive 100 kilometres running routine. Balancing work, exercise, and diets is essential because while healthier lifestyles are important, they ought not to take over our lives or make us miserable because we feel like we need to give up on too much.

The government is preaching abstinence while individuals are finding solutions. We should celebrate the ingenuity of companies that allow us to find smart solutions for complicated problems. On top of that, we should follow scientific evidence and adapt our decision-making accordingly. If the last two decades have taught us anything, it is that we can’t legislate away obesity or medical problems with large-scale policy plans or bans.

Originally published here.

Only the individual can solve Britain’s obesity crisis

As Britain becomes the fat man of Europe, a blanket approach to large-scale policy-making will not solve Britain’s obesity crisis. Only the individual can do the work, argues Bill Wirtz.

Am I overeating? This question is, in essence, a modern one. Our ancestors would have stood in awe at the sheer availability of refrigerated and affordable meat in our supermarkets. Even items such as salt or sugar, once luxury items, are now abundantly available in everyone’s cupboards.

With this luxury, we also face the genuine problem of obesity. Eating habits are complicated: we are stressed and strapped for time, and work-related lunch breaks are either a quick sandwich over our desks or lush business buffets to get someone to sign a deal. All too often, we “treat” ourselves to something that exceeds our optimal calorie intake, especially during this pandemic, which has upset our regular schedules.

As I’ve been explaining on this site on a few occasions, the path of lifestyle regulations is neither practical nor modelled after what we want a free society to be. Banning “buy one get one free” pizza options or banning fast-food ads on public transport is infantilising. It presumes that consumers aren’t free to make their own choices, and far worse, assumes the government ought to be the judge of a healthy diet. However, despite hiring highly educated individuals, the government isn’t free from monumental failures on dietary recommendations. Those readers who remember being instructed on the old-school food pyramid will be able to attest to that.

Personal responsibility is complex, and it will not always provide a workable solution for each individual in a matter of months. Yet, the idea that consumers are left defenceless against big sugary food machinery is dystopian and has very little to do with the truth. From personal experience, I am blessed with being naturally tall and a forgiving metabolism. Still, I revert to easy steps to keeping myself in shape without following a painful or time-consuming routine.

Exercise is one of the keys to a healthier life without depriving myself of the joys of the occasional treat. In fact, exercise is all too often a forgotten key to the solution. In October 2018, Public Health England indicated that more than 37 per cent of 10 and 11-year-olds in London are overweight or obese. It is often mistakenly argued that this is caused by high energy intake, but the obesity rates are dependent on physical activity, which according to Public Health England, has decreased by 24 per cent since the 1960s. Daily calorie intake in the UK is also decreasing each decade.

On top of making sure I go on regular (fast) walks, I also keep myself informed on down-to-earth solutions for regulating my appetite. This 2011 study found that chewing gum reduces the desire for snacks by 10%, which makes a significant dent in my afternoon cravings for those foods that are unhealthy. The benefit is also that this applies just as well to sugar-free gum. On top of the widely known added benefit of preventing tooth decay between regular dental hygiene, it has also been shown that chewing gum leads to increased cognitive performance and productivity. Given that I, as much as many others, currently spend their days on Zoom calls, chained to our desks, I find that sugar-free gum has been one of many practical solutions that helps me snack less and be more focused.

Many people regulate their diets with new apps, calorie counters, or making radical shifts in their diets. Be it getting rid of meat or only eating meat, the array of digital solutions and dietary diversity shows that there are no one-size-fits-all solutions. To many governments, the response to obesity has too often been targeting consumption itself. Instead of using the scientific knowledge we have to our advantage and leading us to individual responses, regulators prefer to find a culprit, then advocating abstinence.

Yes, we lust for high sugar and fat, but that does not make us children that need to be penalised. In our community, in our families, we can be a positive nudge that gets friends or siblings to try new ways of regulating their behaviour. For me, it’s been regular breaks, walks in the fresh air with a podcast, sugar-free gum, and a green smoothie for my veggie intake. For you, it might be a Paleo diet.

Let’s celebrate our responsibility instead of a blanket approach to large-scale policy-making.

Originally published here.

Why a vaccine should cost 250 EUR: Penny-wise and pound foolish

Even if the EU would pay a whopping 250 EUR per dose and 500 EUR per resident, it would end up paying merely a third of what’s being earmarked for the recovery fund.

Michael Bloomberg propels the WHO’s nanny state mission creep

Michael Bloomberg may have a domestic reputation as a tough-talking, three-term big-city mayor who blew hundreds of millions on a doomed presidential campaign, but around the world, his money talks.

For years, his charity Bloomberg Philanthropies has dispensed billions of dollars to global causes near and dear to the billionaire’s heart: climate change, public health, education, and the arts. As a result, in the developing world, Bloomberg’s private giving has propelled him into a kind of swashbuckling private government.

When he banned large sodas in New York City, he was only getting started. “Mayor Big Gulp” has global ambitions. Whether in Japan, India, Peru, or the Philippines, Bloomberg’s dangling of free money has led to jacking up tax rates on consumer products such as sodas and cigarettes, providing intellectual rigor for harsh bans and restrictions on alcohol and vaping devices, and coaxing health ministers to accept advertising restrictions on children’s cereals.

Thanks to his nanny state war chest, Bloomberg was named this week to a third term as the World Health Organization’s “Global Ambassador for Noncommunicable Diseases and Injuries,” a mission he has personally funded for several years. While Bloomberg’s recent investments into COVID-19 response and research are laudable, his decadeslong mission to export the nanny state abroad via the WHO’s soft power is damaging, not to mention paternalistic. And the WHO has helped sow the seeds for the current pandemic more than we know.

The WHO has always been a bloated bureaucracy with sky-high luxury travel costs and an allergy to serious reform. But it was WHO’s failures in the 2013 Ebola outbreak that began to shed light on how it had lost its way. The organization admitted as much just six years ago. The Ebola outbreak “served as a reminder that the world, including WHO, is ill-prepared for a large and sustained disease outbreak,” it declared.

While inefficiency was the main culprit, it is not difficult to see how the WHO has been unfocused along. The mission creep of the WHO, focusing more on soda taxes and making e-cigarettes illegal in third-world countries, all funded by Bloomberg’s initiatives, helps explain the tepid response to the breakout of the coronavirus in China, which led to President Donald Trump withdrawing the United States from the health body in 2020. President Biden reversed that decision in his first days in office, without so much as a polite request for reform.

The various missteps of the WHO in the run-up to the pandemic, coupled with its wavering mission to protect us from global disease outbreaks, is a principal reason why we should oppose Bloomberg’s global nanny state expansion. Even now, Bloomberg’s charity is funneling millions into the health agencies of countries such as the Philippines and India, all in exchange for specific bans and consumer product restrictions, which have called into question the influence of the billionaire’s reach. That led Indian Prime Minister Narendra Modi to cut off some of Bloomberg’s purse strings in 2014 and has sparked recent investigations into Bloomberg’s shady donations to the Philippines’ FDA.

These actions are not only praised by the WHO but are facilitated and made necessary to receive any future funds. That is where the WHO is leading us astray. Rather than equipping doctors and health systems to fight the next pandemic, Bloomberg’s deep pockets deputize the WHO as a global police officer enforcing soda taxes, tobacco bans, and restrictions on vaping devices in the developing world.

Bloomberg’s global nanny mission creates problems for public health, and it is even more worrying for the prospect of a global disease outbreak that would make COVID-19 lockdowns look painless.

Yaël Ossowski (@YaelOss) is deputy director of the Consumer Choice Center, a global consumer advocacy group.

Originally published here.

Europe’s new Pharmaceutical Strategy needs adjustments

The existing IP framework of the EU has allowed us to get a vaccine before Christmas.

The rapid development of several highly effective vaccines against COVID19 is a great success for humanity. The United Kingdom was the world’s first country to approve a COVID vaccine, and hopefully soon, the European and US drug agencies will follow the UK’s lead.

Thanks to the very robust intellectual property (IP) framework the EU has, we were able to have the first effective COVID vaccine being developed in the EU (Germany) by a European company backed by European venture capitalists. The response of many innovative pharmaceutical and biotech companies has shown how important they are for humanity to respond to new threats such as COVID swiftly. Companies such as BioNTech, Moderna, and AstraZeneca have quickly responded early on by developing new and ground-breaking vaccines that will make 2021 most likely more enjoyable than this current year. The next pandemic might just be around the corner. Given how many humans have suffered and even lost their lives from COVID and the immense economic toll on Europeans, we need to do everything we can to foster and not stifle innovation in Europe.

Our resilience can only be increased by embracing innovation (the permission to use gene editing for covid vaccines is a good example) and allow risk-seeking investors such as venture capitalists and companies to benefit from their investments. Intellectual property rights are an essential factor. While the Commission’s new pharmaceutical strategy acknowledges IP rights as a safeguard for innovation, it also aggressively talks about centralizing pricing and reimbursement decisions away from member states and towards a unified European approach. This could be horrible news for our resilience when facing future public health crises. 

The COVID pandemic has worsened public and personal finances and hence reduces patients’ accessibility to medicines. If we want to increase access to drugs in all parts of Europe and, at the same time, maintain our high innovation incentives, we need to focus on creating more prosperity. Ultimately economic growth is the critical driver for allowing more patients to access the drugs they need. Loud rhetoric aimed at eroding patent rights is dangerous saber-rattling that might reduce our ability to innovate in the future and find cures for that 95% of known diseases we can’t cure yet.

We need to acknowledge that there are wealth disparities among EU member states, and we can’t have a one size fits all approach when it comes to access to medicines. EU-wide pricing decisions might delay introducing new medicines across the entire block and hence would be a raise to the bottom in terms of access to lifesaving drugs. We might risk getting innovative drugs at the time of their approval elsewhere in the world. Instead of loud and bold statements to negotiate drug prices down, the Commission should embrace innovation and also work on OECD-wide reciprocity of drug approvals. Why should EU citizens have to wait for the EMA to approve vaccines when they have already proved safe and available to UK residents? 

The EU Commission should maintain our excellent intellectual property standards and not intervene in the national rules for pricing and reimbursement decisions. Furthermore, it is paramount that governments refrain from picking winners in the race for new treatments and vaccines and therefore maintain technology neutrality. The German government, for instance, was quick to invest in one vaccine manufacturer early on. Still, despite a massive injection of taxpayer money, another German company won the race to be the first one with an effective vaccine. Europe is home to half of the world’s top 10 pharmaceutical companies. We should not jeopardize this position but aim for more and not less innovation in the European Union.

Originally published here.

To beat cancer in Europe, let’s give vaping a chance

The European Union’s Beating Cancer plan is our once-in-a-generation opportunity to tackle cancer by embracing innovation and consumer choice.

By following the footsteps of the UK, France, Australia, and New Zealand, we can further achieve our goals by endorsing vaping as a harm reduction tool with incredible potential to help reduce health-associated risks. By doing so, the EU could ensure a better future for smokers.

It has been stressed many times that vaping has been proven to be 95% less harmful than smoking. And yet, despite the sound evidence at hand, anti-vaping rhetoric persists and continues to win the hearts and minds of European policymakers. However, in order to develop the most efficient and effective policies to tackle cancer, it is crucial to stay open-minded, and we should always be led by science over ideology.

Smoking-induced cancer takes nearly 700,000 lives every year in the EU, and various marketing schemes and branding restrictions haven’t succeeded in reducing these numbers. When conventional methods don’t work, innovation in the form of vaping must be embraced.

Unlike traditional cigarettes that create more than 7,000 chemicals when burned, 69 of which have been identified as potential carcinogens, vape liquids’ compounds are common food ingredients deemed safe and not harmful by regulatory bodies including the European Food Safety Authority (EFSA). Moreover, when compared to other alternatives in getting people to quit, including Nicotine Replace Therapy (NRT) patches and drugs, vaping has been found to be twice as effective.  

Vaping has the potential to drive down smoking-induced cancer rates significantly. The cancer risk of vaping relative to smoking is 0.4% according to a study conducted by the University of St. Andrews. The additional lifetime cancer risk for an e-cigarette user is 0,0095% compared to 2,4% of a smoker found by the same study. At present,t the European Union has 140 million smokers and many of them struggle to quit. Therefore, we need every possible method available to them to make quitting easier. We must expand their choices.

Consumer choice is more than an empty economic term: it is an essential part of our individual pursuit of what we perceive to be best for us, and the ability to do so voluntarily. The Europe Beating Cancer plan is a chance for Europe to inform smokers about vaping and how it can assist them in their efforts to quit. Another important part of the plan should be to actively encourage smokers to switch to vaping and guarantee access to vaping products for adults. 

Since it is impossible to change consumers’ smoking behaviour with a stick – not least because it is inhumane to disregard our freedom to choose – we need to go with encouragement and correct information as our main strategy. 

Creating and sustaining conditions under which adult smokers are able to switch to healthier options such as e-cigarettes is not only a forward-looking solution but also the one that would demonstrate the European Commission’s commitment to tackling cancer without undermining consumer choice. Europe’s Beating Cancer plan should become not just a policy roadmap, but also manifest Europe’s openness to innovation and recognition of freedom as the highest value. Smokers and future generations would be eternally grateful.

Originally published here.

The EU ‘should consistently charge no VAT on medicine’

In a recent move, the European Commission has suggested to EU member states to exempt Covid-19 diagnostic medical devices, as well as a potential vaccine, from value-added tax. The Consumer Choice Centre (CCC) has welcomed this move, since it incentivises a move to alleviate some of the burdens on patients and consumers as they deal with the pandemic. The CCC’s Managing Director and Health Economist Mr Fred Roeder said the EU should be more ambitious with regard to medicines.

“Member states would be right to implement VAT exemptions on medicines, not just in times of a crisis,” he commented.

“Too many patients in Europe pay too much for needed medicines because the government is taking too big of a cut. Some member states charge as much as 25 per cent for both over-the-counter (OTC) medicines, as well as prescription drugs. This burdens health insurance providers and patients alike”, said Mr Roeder.

“We should take the positive example of Malta, which is the only member state that charges no VAT for either OTC or prescription medicine, yet still manages to provide basic services to citizens. If we want to fund government services, we shouldn’t do it on the backs of patients who need medicine.

“We experience this great double standard in Europe: Politicians of major parties complain about the price of drugs on the continent, yet simultaneously charge large chunks of tax on the same drugs. It is time we end this inconsistency”, he concluded.

Originally published here.

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