Why Regulation Matters: The Role of Drug Policy in Equitable Access to Medicines

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When you pick up a prescription, you probably trust that your medicine is safe, effective, and high quality. But this trust doesn’t come by chance—it comes from regulation. Governments and health authorities design rules to make sure medicines work the way they should. Yet, regulation is not only about safety—it also decides whether people can actually get the medicines they need.

Strong drug policies can save lives. But overly strict or poorly designed ones can create barriers, leaving millions of patients without access to essential treatments. Let’s take a closer look at how regulation works, and why it matters for equitable access to medicines.

What Does the FDA Do?

In the U.S., the Food and Drug Administration (FDA) plays a key role in regulating drugs. Its responsibilities include:

• Approving new drugs – including prescription, generic, biosimilar, and over-the-counter medicines.
• Ensuring safety and quality – requiring data that proves each drug is effective for its intended use.
• Monitoring drugs after approval – collecting reports from patients, doctors, and manufacturers, and updating drug labels or recalling products when necessary.

The FDA’s work continues long after a drug is on the shelves, protecting patients at every step.

When Regulation Blocks Access

While regulation protects public health, drug control policies can also make vital medicines harder to get. Many substances judged to be “dangerous” have important medical uses, yet patients in need often can’t access them.

For example:

• 75% of the world’s population—about 5.5 billion people—live in countries where effective pain-relieving medicines are largely unavailable.
• Each year, millions of cancer and AIDS patients suffer from untreated severe pain.
• Families sometimes move across borders to get care, like the parents of two-year-old Tristan Forde, who relocated from Ireland to Colorado so their child could access medical marijuana for seizures.

Morphine, the gold standard for pain relief, is inexpensive—but over 90% of the world’s morphine is consumed in wealthy countries, which make up only 17% of the population.

Mental Health and Addiction Treatments

Drug policies don’t only affect pain relief.

• Many people with mental health conditions lack access to antidepressants and antipsychotics.
• Addiction treatments like methadone or buprenorphine are tightly controlled or even outlawed in some countries.
• Doctors often avoid prescribing controlled medicines due to stigma, fear of legal consequences, or complex paperwork.

These barriers leave millions without care they urgently need.

Barriers to Research

Strict drug policies can also limit scientific progress.

• Cannabis and cannabinoids have shown potential for epilepsy, cancer pain, and nausea, but remain difficult to study in many countries.
• Indigenous plants like ayahuasca and peyote, traditionally used for healing, are rarely researched due to legal restrictions.

When research is blocked, so is the chance to discover new therapies.

Striking the Right Balance

Of course, governments must protect people from harmful drug use. But leaning too far toward control can cause real harm by denying patients proven treatments.

• Opioid medicines like morphine, oxycodone, and codeine are essential for severe pain but are often underused in much of the world.
• Ketamine, a critical anesthetic in low- and middle-income countries, faces growing restrictions because of its hallucinogenic effects.

The challenge is to balance safety with availability.

The U.S. Example: High Prices as a Barrier

Even in wealthy countries, access is not guaranteed. In the U.S., prescription drug prices are more than 2.5 times higher than in other high-income nations.

To address this, the Department of Health and Human Services (HHS) has set priorities to:

1. Make drug prices more affordable and equitable.
2. Improve competition in the pharmaceutical market.
3. Encourage innovation while reducing costs.

Recent actions include encouraging the use of generics and biosimilars—which are typically 15–35% cheaper—and passing more savings directly to patients at the pharmacy counter. These steps show how policy can expand access by lowering costs.

Conclusion

Drug regulation is essential for safety, but it also determines fairness. Patients around the world continue to suffer when policies focus too much on control or allow high costs to block access.

The path forward requires smart, balanced regulation—one that safeguards people from harm while ensuring they can receive the medicines they need. Because at its heart, equitable access to medicines is not just a healthcare issue—it’s a matter of human dignity.