Pharmaceuticals have been spared so far from the growing trade war between the United States and many other nations. But that run of fortune may soon be coming to an end as President Trump said recently that the United States will announce a “major” tariff on pharmaceutical imports “very shortly.” While we do not know what the delay in implementing other tariffs means for the threatened tariffs on pharmaceuticals — those on automobiles, for example, are going ahead as planned — the implications of tariffs on pharmaceuticals could have a dramatic impact on multiple areas throughout the US and global healthcare ecosystem.

Tariffs on medicines will, of course, increase prices for US patients. But, as with many other aspects of the fast-moving trade war, this one is likely to have unintended consequences as well. We think that companies should prepare now with an eye to mitigating problems and be prepared to communicate the ramifications of tariffs on health-related areas to diverse audiences, from regulators and policymakers to health providers and patients.

The most likely knock-on effect is on patents and other intellectual property (IP). The US has traditionally protected IP belonging to American companies and the global IP system by threatening trade retaliation against countries that do not respect IP. Those threats may now ring a bit hollow, especially among the countries most well-positioned to capitalize on erratic US policies on biopharma IP.

China

The semi-official Global Times reported on April 9 that China might consider “investigating the intellectual property benefits of US companies operating in China.” China has responded robustly to tariffs of 145% on most of its exports to the US. Vice-President J.D Vance’s characterisation of Chinese as “peasants” may complicate trade negotiations, making it very difficult for the Chinese government to seek conciliation instead of escalation.

As our colleagues have already pointed out, China sees a vast opportunity in the US’s exit from global health. China’s thriving biotech and life sciences sector wants to do more to supply South Asia, Africa, and Latin America. Its COVID vaccines were deployed across the world, but China is positioning its vaccines industry to meet routine and pandemic needs.

The 14th Five-Year Plan (2021–2025) explicitly prioritised biotechnology as a strategic sector for national development, aiming to position the country as a global leader in the bioeconomy by 2035. The Healthy China 2030 and Made in China 2025 initiatives have prioritised development of medical R&D and manufacturing, both in small molecules and biologicals. The government uses subsidies, financial incentives, public-private partnerships, and talent recruitment programmes to foster biotech innovation. High-tech science parks and innovation hubs have been established in regions such as Shanghai and Shenzhen to strengthen industrial capabilities. China is particularly focusing on synthetic biology, gene editing, stem cell research, brain science, and regenerative medicine.

There is an obvious synergy here. China may well relax IP protections for US-based companies, while maintaining its strengthened domestic IP regimen. At its most basic, this would allow Chinese producers to export biosimilars and generic copies of small molecules still protected by patents in the US and EU. Probably more significant would be the shortcuts it might allow Chinese developers in producing new therapeutics and vaccines that build on established American discoveries.

India

In 2022, almost half of US generic medicines came from India. New tariffs could dramatically affect the affordability of medicines within the USA.

India is, for now, not responding to tariffs of 26% on most of its other exports and is putting its hopes on a bilateral trade agreement (BTA) to be concluded by the third quarter of 2025. It may happen, but because presidential authority to conclude trade agreements has expired, the agreement would require Congressional approval and that is usually a fraught process. Absent a BTA, India will look for leverage and, to encourage a BTA’s progress, it may seek to apply pressure in the meantime. In this, India’s government has an advantage: it can leave action to India’s sophisticated civil society sector and the country’s activist courts.

India has long been on the US Priority Watch List for intellectual property (IP) protection and enforcement because of rumbling disputes over administrative and legislative issues. However, India’s generics industry has largely been forced to respect IP on medicines since the early years of this century. That could change without any provocative action by India’s government.

India has recently taken steps to expedite the approval of new treatments based on registration by stringent regulatory authorities such as the EMA and the FDA. Based on these approvals, ordinary Indians can import medicines for personal use. This probably has an untested implication for patents.

India’s Supreme Court has long held that a patent can only be valid in India if the patent holder is “working the patent” in the country; practically this means that a medicine discoverer has to have taken some reasonable steps to make its treatments accessible to Indian patients. The slow pace of approvals in India — and the option of submitting for approval later than in other countries — has meant that developers could control application of this doctrine in the past. Courts might now say that there are few good reasons for a delay in availability in the country and that failure to provide access in these circumstances could invalidate a patent.

India’s government can honestly say that it is powerless to control the courts and fairly helpless to resist activism around patents — look, for example, at the scholarship and training on India’s ever-excellent SpicyIP website. A new trade agreement with the US, when applied fully, could reinforce IP protection but, in its absence, the government can say with some justification that it would have trouble getting any new legislation on pharma IP through the two chambers of Parliament.

As with China, a more subtle threat may come from India’s emerging R&D-based vaccines and medicines industry. The job of developers is much easier if they can use the trade secrets of established rivals.

Ireland

The pharmaceutical industry may have some relief because it holds so much of its intellectual property in Ireland. This is a very sore point for the Trump Administration, but could mitigate the danger from any future moves by China, India and other countries to “investigate US intellectual property benefits”: no-one wants a trade war with the EU as well as the US.

Ireland has, however, been a laggardly partner to the pharma industry. It has been slow to adopt the EU’s United Patent Court (because doing so requires a referendum in Ireland). More seriously, it is one of the slowest countries in Europe to grant access to new medicines. This does not create a legal hazard for patent holders but it does weaken the country’s moral and public relations case, especially because Ireland’s delays are partly the result of policies that favour inefficient national generic producers.

Impact of IP threats

Weakening intellectual property may offer short-term improvements in access, but has many long-term risks.

Generics from India, in particular, are associated with much higher risks to patients than medicines produced in Europe, Israel, Jordan or North America. We don’t yet know enough about generics from China.

It is intellectual property that powers innovation. Developing new drugs is a high-risk, costly endeavour, often requiring billions of dollars and over a decade of research. Strong IP protections, such as patents, allow companies to recoup these investments by granting them exclusive rights to market their products for a defined period. This exclusivity ensures that innovators can profit from their discoveries without immediate competition from generics or imitators. Strong IP frameworks also encourage partnerships between pharmaceutical companies, universities, and research institutions and enable the sharing of expertise and resources, accelerating the development of new treatments while safeguarding proprietary knowledge.

What can companies do?

The evolving global trade outlook is changing by the day, and sometimes by the hour, so it is important to have one or more internal task forces with public affairs experts and consultants in China, India and Latin American markets with some similar dynamics — Brazil, Colombia and Mexico, in particular. Having an internal and an external perspective with clear lines of communication with expert advisors is very important in our current trade climate because different people know different things in fast-changing scenarios. There needs to be a different task force in Ireland, a country that will likely come under unaccustomed scrutiny.

Access planning may be the best mitigation for many of the risks. It is important in India for obvious reasons. It may be important in other countries as part of a response for moves by generic producers elsewhere.

Communication with policymakers and influencers matters more than ever. Policy responses will happen in a far more condensed time frame than they usually do. Having open channels may make all the difference, as well as having a tested protocol in place that allows companies to rapidly distinguish and mitigate misinformation before it influences policy direction. There are many consultancies and advisers with expertise, but it is important to include ones who have worked on intellectual property as well as trade.

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It may seem an almost impertinent question if you’re a drug developer. After all, the often-used response that investigators give to trial participants has been ‘good enough’ for decades: patients’ health may benefit from participation, and, whether they are in the active or placebo arm of a study, they have the satisfaction of knowing that they helped others with their disease by taking part. It’s true, and yet, today, it feels as though it falls short.

Patients living with life-threatening diseases have all their skin in the game.  Their time equals life, the ultimate valued commodity. These are the ready, motivated participants for clinical trials, and in exchange for their time and data, they and the organizations that advocate on their behalf should benefit from drug development through royalties that directly fund future research and advocacy priorities. When communities’ needs converge, great change is possible.

More Efficient Fundraising Drives More Immediate Patient Benefit

For decades, patient advocacy groups have looked to galas, walks and events as the prescribed formula to raise essential funds.  These gatherings are important opportunities to rally society, unite allies and sustain community, but they also take time, and the need for speed calls for creativity in advancing science.  Advocates should look beyond filling tables of 10. Their strategic plans should include partnering with contract research organizations (CROs) as pathways to advance drug development as well as fostering awareness, advocacy and treatment as part of their missions. 

The currency that makes this possible is the exchange of data, which are essential to all therapeutic advances. That requires patient advocates to think differently about working within their communities and with academic centers, contract research organizations and industry.

“The need for diversity and greater decentralization in clinical trials will requires new kinds of data exchanges with patients,” notes Irfan Khan, MD,  CEO, Circuit Clinical. “With our industry’s need for these novel collaborations also comes the chance for real change.”

Data as Currency

Amazon, Apple, eBay, Facebook, Google, and a host of other immense social communities prove repeatedly that data are essential currency for economic success. Giants in consumer data analytics get smarter by tracking online information, transforming searches into “what to buy next” prompts. Whether we accept or reject their approach to user privacy, we must also acknowledge their mastery of data monetization.

The concept should be nothing new for academic research centers, which have long monetized health data. Google Scholar and University of California-Berkeley Professor Dawn Song created a secure path for patients to share data with researchers by launching software company Oasis Labs. Why can’t patient groups also benefit from this approach?

Paddy Padmanabhan, co-author of the best-selling book Healthcare Digital Transformation — How Consumerism, Technology, and Pandemic are Accelerating the Future writes, “As traditional healthcare enterprises confront emerging competition from non-traditional players, some of them have started realizing the competitive advantage they have in the form of vast amounts of data they have on healthcare consumers’ medical histories.” Those ‘non-traditional players’ don’t just mean Amazon or Google — they may well be the patients themselves organizing to ensure they have greater sway in setting clinical priorities.”

Facilitating — and Funding — Innovation

Patient advocacy groups can build models that amass more information for clinical research and even work to fund these initiatives as partners. Before planning their next virtual gala or whiteboarding ideas on determining their “Ice-Bucket Challenge” moment, they should also look at how the ALS Association applied those monies to increase research funding and accelerate clinical possibilities. Beyond simply providing capital to fuel innovative ideas, they became drug start-up companies’ investment partner.

There are many ways to use data to create mutually beneficial partnerships. The GenTAC Alliance (National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Related Cardiovascular Conditions), launched by NHLBI and NIAMS, enrolled more than 3,600 patients between 2006 through 2016. By putting this registry to work, The Marfan Foundation is looking to partner with biopharma companies to fulfill its patient-support mission to discover new treatments and cures for life-threatening genetic aortic conditions.

Biopharma companies already want patients and their communities to have a seat at the table, but collaboration is more than simply communicating. It’s about creating common ground for mutual success. Economic models that address multiple interests may be a new remedy to make that happen more frequently, and groups such as Let’s Win for Pancreatic Cancer and The Christopher and Dana Reeve Foundation have taken on pinpointing cutting-edge research that may sustain life, bringing collaboration with drug developers to another level.

The culture of drug development is shifting. In the new edition of Alzheimer’s Disease Drug Development – Research and Development Ecosystem, edited by Drs. Jeffrey Cummings, Jefferson Kinney and Howard Fillit, there is a chapter dedicated to “The Role of Professional and Patient Advocacy in Advancing Alzheimer’s Disease Drug Development.” I was privileged to co-authored this chapter with neurologist and psychiatrist Amir Kalali, MD where we note: “While fund-raising efforts such as walks, galas, golf outings, and conference sponsorships still occupy their workflow (of advocacy groups), the focus on these monies in the digital era has shifted from awareness building to being leading sources of research funds.”

Can Patient Advocates be Agents for Patient Data?

Companies such as Hu-manity.co pose an essential answer to the question, “who owns your data?” Its Founder and Board Chair Richie Etwaru wrote, “…the simple idea that we should put the consumer (the patient) into the center of the healthcare data supply chain with ownership rights literally at their fingertips is both powerful, and timely.”

This is a movement in the making. Biopharma companies might find that by advancing this idea, they can accelerate mutual interests. Craig Martin, CEO for Global Genes Foundation Alliance, a rare disease advocacy community with more than 600 member organizations, advocates for a more inclusive partnership between patient groups and the biopharma industry.

Industry so far seems receptive. Led by Co-Chairs Amir Kalali, MD, and Craig Lipset, The Decentralized Trials & Research Alliance, a 150+-member organization uniting industry, academic centers, contract research organizations (CROs), regulators and patient advocates, is sparking the conversation among a research community that speed, diversity and inclusion in bringing new therapies to market — and to patients — is in everyone’s best interests.

It’s Not About Going Virtual — It’s About Collaboration and Mutual Benefit

Apple, Google and Microsoft are dominant companies to follow for trends and developments in technology. But they are also advancing collaborative economic models that drug developers and patient communities should emulate. They pioneered the idea of mining unpolished data and turning it into a new currency for commerce.

All drug development is built on clinical research, in which patients’ participation is essential in defining safety and efficacy. Increasingly patient groups are realizing the vital importance in the role they play. What might happen if industry more equitably includes patients and their advocates? Could timelines be advanced if patient groups had benefits similar to research sites and CROs? What might happen if Food and Drug Administration Advisory Boards were required to meet with patient advocacy ambassadors to accountably explain how their recommendations impact future care and innovation?  

We know the past.  We have attended enough patient advocacy galas to acknowledge the need to learn from other successful models. Deploying data is the obvious, simple economic pathway for accelerating decision-making and growth. But, less obvious, data are also the currency that may enable patients and advocacy groups to accelerate their own missions, becoming full-fledged partners in driving innovation and drug development, while becoming stronger, more sustainable communities.

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Relying on intellect and knowledge, we embrace science and molecules that can be patented, tested, peer-reviewed and approved by third-party sources. However, as I look at the narratives of those who live and those that die — the people we seek to help and heal — I see within health information and innovation and the provider approach chinks in our armor. I see the too often-untapped human element that transforms marvelous medicines into people’s survival miracles. I see something missing from within the drug research, discovery and review process. I see that medical records remain challenging for professionals and patients to access and apply. I see how thoughtful communication can be used to create hope and avoid hype.

Communication defines how innovation can bring hope to humanity. Hope remains one of the most under-appreciated elements in the patient-treatment process.

I was a team lead when Hoffmann-La Roche introduced the first biologics for the treatment of cancer — alpha interferon. The launch activities included a New York City media briefing. The speaker line-up included the best and the brightest researchers in the biopharma oncology field — including Dr. Jerry Groopman, the now Dina and Raphael Recanati Chair of Medicine at Harvard Medical School, Chief of Experimental Medicine at Beth Israel Deaconess Medical Center. Groopman is an outstanding scientist who has grappled for years with the role “hope” plays in healing.

Through the years, I have revisited Groopman’s outstanding volume, The Anatomy of Hope — How People Prevail in the Face of Illness. The book recounts his journey into medicine. The challenges physicians face as they look into the stares of people they treat with a life-threatening illness and chronic disease. The physician’s hunger for information and how the “ideology of the right to know,” can also suffocate patient hope. It’s the story of a great physician/scientist trying to balance his passion for the lab and patient care, with the universe we cannot see or touch.

“I understand hope as an emotion made up of two parts: a cognitive part and an effective part. When we hope for something, we employ, to some degree, our cognition, marshaling information and data relevant to a desired future event. If…you are suffering with a serious illness and you hope for improvement, even for a cure, you have to generate a different vision of your condition in your mind. That picture is painted in part by assimilating information about the disease and its potential treatments.

“But hope also involves what I would call affective forecasting — that is, the comforting, energizing, elevating feeling that you experience when you project in your mind a positive future. This requires the brain to generate a different affective, or feeling, state than the one you are currently in.”

Jerome Groopman, The Anatomy of Hope — How People Prevail in the Face of Illness

Throughout my career journey, as a combat medic, health policymaker, health communications professional, I embraced (and will continue to respect) orders and legal, medical and regulatory direction. Along with my rewarding life in heath communications, as an ordained rabbi, called upon to visit the ill and very ill, I find myself walking hospital hallways and being welcomed into people’s homes, listening, comforting and, yes, hoping for their recovery and return to health.

In the past 30 years, I have been privileged to help biopharmaceutical and health tech companies introduce scores of new medicines and devices into the marketplace for lifestyle and medical conditions. Today, in my varied leadership roles, I see my colleagues around the world dedicate themselves — with incredible heart and smarts — to ensure balanced, accurate information is shared so that people — patients, physicians, payers and advocates — can make informed decisions on next steps.

I remain amazed at how many obstacles exist that diminish quality care and people’s — both physician’s and patient’s hope — from challenges to accessing medical records as people journey from one medical institution to another to switching people’s medication for no apparent reason to struggling to gain sufficient talk time with their doctor to understand what is happening with their medical condition.

It’s frustrating. Yet, let us not despair. Let’s be optimistic. Medicine and hope are allies in healing. Communication is not separate from the collective mission to heal. Communication is hope’s bridge that unites science with care, and physicians and patients with their inner fire to heal and be healed.

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