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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Ignoring food’s role in health denies its benefits and risks related to the lack of it. The current expression is not just implying that food is a pharmaceutical (which it would appear to be) but that prescribing food is a medical necessity.

The long-term effects of COVID-19 are adding to the yearly death toll from diet-related chronic diseases in the US, which already stands at about one million. In the United States, malnutrition and chronic diseases such as type 2 diabetes, cardiovascular disease (CVD), obesity, and certain malignancies are closely linked to poor dietary habits, making them the primary cause of death.

Among individuals in the United States, about 40% have pre-diabetes, and 11.3% have diabetes; most of these instances are type 2 diabetes. Around 37% of the U.S. population, or 126.9 million people aged 20 and more, will be living with cardiovascular disease in 2022. In 2021, there were 695,000 fatalities in the United States because of CVD, making it the top cause of death for both men and women.

Food Pharmacies

The food pharmacy is one new program model that aims to improve people’s diets by expanding their access to and consumption of healthy foods, especially produce. According to the available studies on the food pharmacy model’s effectiveness, these programs have helped patients better understand nutrition and overcome obstacles to healthy eating. As a result, they may have a major influence on health outcomes connected to diet.

Nevertheless, there has been a dearth of thorough research techniques and limited efforts to assess these programs’ efficacy. To properly evaluate the long-term impacts of food pharmacy programs on healthy eating and diet-related health outcomes, additional study is required. But the current evidence provides more than food for thought on the topic. How is this concept implemented?

Therapeutic meals are meals specifically designed to meet medical needs, and the food as medicine initiative also includes prescriptions for healthy food, produce, and other foods. They are usually supported by healthcare, the government, or charitable organizations, administered by clinicians through the healthcare system, and patients pay nothing or very little for them. But these programs are limited to specific areas of the world.

Researchers identified 32 papers in the literature examining food as medicine interventions using a PubMed database search and by polling a network of international colleagues. Several instances were located in other Western countries, although the majority were in the US. Other countries that contributed were Canada, the UK, and Australia. Brazil, Mexico, Germany, Ireland, and Finland did not have any. Philanthropic funding, rather than institutional or organizational backing, was crucial for the majority of activities. Statistics on the health effects of food-as-medicine programs were inconsistently available in the scholarly literature, reflecting these endeavors’ relative newness.

How Do They Work?

Located in Boston Medical Center! Founded in 2001, the Food Pantry dedicates itself to assisting low-income patients in overcoming nutrition-related illnesses and undernourishment. The Food Pantry serves as a bridge between patients and healthcare providers such as dietitians and doctors. Doctors at BMC clinics provide food prescriptions to improve patient health. Patients having cancer, HIV/AIDS, high blood pressure, diabetes, obesity, cardiovascular disease, and other long-term illnesses frequently visit the Pantry.

When it comes to nutrition, the goal of the food pharmacies at Children’s Hospital of Philadelphia is to help families struggling to put food on the table. They strive to ensure that families have access to the food and financial resources they require by providing direct grocery delivery to their homes and offering one-on-one resource navigation. Grocery delivery, financial consulting, and free fruit markets are a few of the programs provided because of partnerships with local businesses and organizations. Families who sign up for the Food Pharmacy program get free groceries for six months.

Another program that integrates medicine and food is at Tufts University. The Food Is Medicine launched this university-wide initiative at Tufts University’s Friedman School of Nutrition Science and Policy. Its goal is to improve health care by implementing scalable food-based interventions. Interventions include nutritional meals, doctor education, and improved clinical care for diet-related illnesses.

The University of Utah Health’s response to food insecurity is the Food Pharmacy program. This initiative is a component of the larger Driving Out Diabetes effort. In late summer of 2020, the program was initially offered. Its goal is to help those in the community who are food insecure and dealing with long-term health issues related to nutrition.

The food pharmacy is a trailer that can be moved and has all the necessary equipment for food service. Patients with a meal prescription from their clinician have access to a large selection of nutritious food options held by the pharmacy.

Eligible individuals with valid referrals or prescriptions can pick up meals from the trailer at two sites during business hours.

The value of nutritious foods and meals cannot be overstated as we see the relationship between nutrition and disorders of physical and mental health. In addition to providing healthful foods, these programs also encourage people to educate themselves regarding what they should eat; in addition, the programs, in the long run, can save government money on treating illnesses resulting from poor nutrition. One of the prime examples of these illnesses is obesity worldwide, which is of prime importance in health and medicine.

The post Food Is the Prescription, and Food Pharmacies Could Be the Way to Better Health appeared first on Medika Life.

Many people living on the streets in Philadelphia’s Kensington neighborhood — the largest open-air drug market on the East Coast — are in full-blown addiction, openly snorting, smoking, or injecting illicit drugs, hunched over crates or on stoops. Syringes litter sidewalks, and the stench of urine fouls the air.

[This story also ran on U.S. News & World Report and is reprinted with permission from KHN.]

The neighborhood’s afflictions date to the early 1970s, when industry left and the drug trade took hold. With each new wave of drugs, the situation grows grimmer. Now, with the arrival of xylazine, a veterinary tranquilizer, new complications are burdening an already overtaxed system.

“It’s all hands on deck,” said Dave Malloy, a longtime Philadelphia social worker who does mobile outreach in Kensington and around the city.

Dealers are using xylazine, which is uncontrolled by the federal government and cheap, to cut fentanyl, a synthetic opioid up to 50 times stronger than heroin. The street name for xylazine is “tranq,” and fentanyl cut with xylazine is “tranq dope.” Mixed with the narcotic, xylazine amplifies and extends the high of fentanyl or heroin.

But it also has dire health effects: It leaves users with unhealing necrotic ulcers, because xylazine restricts blood flow through skin tissue. Also, since xylazine is a sedative rather than a narcotic, overdoses of tranq dope do not respond as well to the usual antidote — naloxone — which reverses the effects of only the latter.

Xylazine has been spreading across the country for at least a decade, according to the Drug Enforcement Administration, starting in the Northeast and then moving south and west. Plus, it has proven to be easy for offshore bad actors to manufacture, sell, and ship in large quantities, eventually getting it into the U.S., where it often circulates by express delivery.

First detected in Philadelphia in 2006, xylazine was found in 90% of street opioid samples in the city by 2021. That year, 44% of all unintentional fentanyl-related overdose deaths involved xylazine, city statistics show. Since testing procedures during postmortems vary widely from state to state, no comprehensive data for xylazine-positive overdose deaths nationally exists, according to the DEA.

Here in Kensington, the results are on display. Emaciated users walk the streets with necrotic wounds on their legs, arms, and hands, sometimes reaching the bone.

Efforts to treat these ulcers are complicated by the narrowing of blood vessels that xylazine causes as well as dehydration and the unhygienic living conditions that many users experience while living homeless, said Silvana Mazzella, associate executive officer of the public health nonprofit Prevention Point Philadelphia, a group that provides services known as harm reduction.

Stephanie Klipp, a nurse who does wound care and is active in harm reduction efforts in Kensington, said she has seen people “literally living with what’s left of their limbs — with what obviously should be amputated.”

Fatal overdoses are rising because of xylazine’s resistance to naloxone. When breathing is suppressed by a sedative, the treatment is CPR and transfer to a hospital to be put on a ventilator. “We have to keep people alive long enough to treat them, and that looks different every day here,” Klipp said.

If a patient reaches the hospital, the focus becomes managing acute withdrawal from tranq dope, which is dicey. Little to no research exists on how xylazine acts in humans.

Melanie Beddis lived with her addiction on and off the streets in Kensington for about five years. She remembers the cycle of detoxing from heroin cold turkey. It was awful, but usually, after about three days of aches, chills, and vomiting, she could “hold down food and possibly sleep.” Tranq dope upped that ante, said Beddis, now director of programs for Savage Sisters Recovery, which offers housing, outreach, and harm reduction in Kensington.

She recalled that when she tried to kick this mix in jail, she couldn’t eat or sleep for about three weeks.

There is no clear formula for what works to aid detoxing from opiates mixed with xylazine.

“We do need a recipe that’s effective,” said Dr. Jeanmarie Perrone, founding director of the Penn Medicine Center for Addiction Medicine and Policy.

Perrone said she treats opioid withdrawal first, and then, if a patient is still uncomfortable, she often uses clonidine, a blood pressure medication that also lessens anxiety. Other doctors have tried gabapentin, an anticonvulsant medication sometimes used for anxiety.

Methadone, a medication for opioid use disorder, which blunts the effects of opioids and can be used for pain management, seems to help people in tranq dope withdrawal, too.

In the hospital, after stabilizing a patient, caring for xylazine wounds may take priority. This can range from cleaning, or debridement, to antibiotic treatment — sometimes intravenously for periods as long as weeks — to amputation.

Philadelphia recently announced it is launching mobile wound care as part of its spending plan for opioid settlement funds, hopeful that this will help the xylazine problem.

The best wound care that specialists on the street can do is clean and bandage ulcers, provide supplies, advise people not to inject into wounds, and recommend treatment in medical settings, said Klipp. But many people are lost in the cycle of addiction and don’t follow through.

While heroin has a six- to eight-hour window before the user needs another hit, tranq dope wanes in just three or four, Malloy estimated. “It’s the main driver why people don’t get the proper medical care,” he said. “They can’t sit long enough in the ER.”

Also, while the resulting ulcers are typically severely painful, doctors are reluctant to give users strong pain meds. “A lot of docs see that as med-seeking rather than what people are going through,” Beddis said.

In the meantime, Jerry Daley, executive director of the local chapter of a grant program run by the Office of National Drug Control Policy, said health officials and law enforcement need to start cracking down on the xylazine supply chain and driving home the message that rogue companies that make xylazine are “literally profiting off of people’s life and limb.”

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