The advent of a new disease in 1981 would spark a revolution in science and society, and lead to the birth of modern patient advocacy. When AIDS (Acquired Immune Deficiency Syndrome) was identified as a global health concern in the early 1980s, few would have realised the impact it would have on society and especially on healthcare.

Those early days were grim, the reporting of HIV was often horrific, and there were many myths and fears surrounding the disease. And all the while, people were dying.

The medical community, patients, and regulatory bodies had to navigate the challenges of a new disease without many of the tools and processes we take for granted today.

We spoke to Neil Bertelsen, an advocate for the HIV community, to explore the role of HIV patients in the birth of modern patient advocacy and how this changed the regulatory landscape for the better.

Legacy Perceptions of HIV and COVID-19

Neil notes how legacy perceptions of HIV and COVID-19 can influence how we react to new diseases.

“In the 1980s, when HIV first appeared, there were many myths and fears surrounding the disease that were perpetuated by the media, and led directly to discrimination of those with the disease and the communities it affected,” he says. Similarly, in the early days of COVID-19, we witnessed the same fear response, leading to discrimination against healthcare workers treating the first wave of COVID patients. Neil suggests that society needs to “become more adult in its response to infectious diseases and that we need to work together to address these challenges, including a better understanding of risks and relative risks, and more stringent guidance for the media on reporting this”.

The Birth of Modern Patient Advocacy

The 1980s saw the birth of coordinated and sophisticated activism by the HIV-affected communities and through that decade the birth of modern patient advocacy, which was a response to the challenges faced by people with HIV. Those affected and medical professionals came together to learn, at the same time and at the same speed, about the disease. One of the key challenges was a mismatch between the needs of the community and the regulatory rules in place for approving new medicines. To overcome this, activism and then advocacy led to the formation of patient advocacy groups and councils, which advised regulatory bodies on patient perspectives and helped shape regulatory policy.

This marked a significant shift towards patient involvement in regulatory decision-making, which has become a hallmark of modern healthcare.

Neil points out, “Now we have so many advocacy groups that are laser-focused on shaping policy and regulations, some operate at the global level, others cover a region, and of course, we have the national patient groups that are connected to policymakers and understand how their healthcare system works, how decisions are made. These groups are building their own evidence to support patients within the healthcare systems and policy landscape.”.

The FDA’s Role in the Fight Against HIV

During the early days of HIV, the FDA became a lightning rod for dissatisfaction. “The regulators were taking too long to approve medicines. Placebo-controlled trials were the norm, and from the view of the HIV-positive community the regulatory system was just not geared for the fast turnaround needed for a deadly infectious disease,”,” explains Neil. “From the perspective of the HIV community, promising experimental medicines were spending years under review while many thousands were dying.”.

People with HIV and advocates were angry with the slow pace of drug approvals and the regulatory hurdles that stood in the way of life-saving treatments. In essence, similar to today, this was all about access to medicines. The difference is that today it is the payers that control access, back then it was the regulators.

The collective activism led to a change in the summer of 1989 when Neil recalls, “The FDA said, ‘Okay, we’re going to come up with a new system only for life-saving medicines, and this parallel track will allow patients to access a medicine while we’re still going through the review process’. And it’s from that moment that a lot of things that we take for granted in the regulatory world actually came from and marked a significant shift towards patient-centred regulatory policy.”.

Patient Advocacy and Regulatory Bodies

The growth of patient involvement in regulatory bodies has been a significant development in the healthcare industry. Patient advocates now sit on committees and councils that advise regulatory bodies on patient perspectives and help shape policy.

This is a direct result of the advocacy efforts of patients and medical professionals during the HIV epidemic. As Neil says, “What happened in those last years of the 1980s was something that we hadn’t seen before: a genuine coming together of both the medical community and the patient community, where we became hand-in-glove, basically learning at the same speed. At the same time, we had a community of people affected by a disease that self-taught themselves in how regulatory processes worked.”.

This shift in the way the regulators engaged with patients was driven by “the community of people with HIV started to make contact and sit down with regulators to say, ’Hey, how do we work together on this?’” Neil recollects. “That led to the FDA forming what is now their patient engagement policy, and it started with its HIV-specific patient council that advised the FDA and was later expanded to include more diseases”.

However, there is still work to be done to ensure that patient perspectives are fully integrated into regulatory decision-making. One of the emerging trends is the use of ‘patient experience data’ – evidence beyond the clinical that details how patients experience a condition, its treatment and the effects it has on their lives. “We need to make sure that patients, advocates and the affected community are co-creators of this evidence to ensure it is providing decision-makers with evidence on what is important to people with the condition. This means we need to democratise evidence generation so that all sections of society have a hand in shaping the evidence used for decisions.”.

Eye-to-Eye Partnership and Fragmented Networks

Neil notes that one of the missing ingredients in modern patient advocacy is the eye-to-eye partnership that existed between patients and medical professionals during the HIV epidemic. “This partnership enabled a true collaboration, where patients and medical professionals learned at the same time and grew together”. Additionally, Neil argues that the healthcare industry is becoming increasingly fragmented, with many different networks and initiatives that are poorly connected.

He suggests that organisations need to step back and find ways to create a “seamless, interconnected network”. In those early days of HIV, there was no internet or email. Fax machines provided the technology and personal contacts were the network dynamics. People attending seminars in San Francisco would fax the details over to contacts in London, Paris and around the world, and vice versa. “It seems clunky by today’s standards, but it worked,” says Neil. “Today, we have so many different networks we are meant to tap into and the information overload is immense. I do worry about the duplication of efforts that I see all around me these days.”.


The birth of modern patient advocacy can be traced back to the HIV epidemic of the 1980s. Patients and medical professionals came together to navigate the challenges of a new disease and the affected community built a framework for patient involvement in regulatory decision-making as well as patient involvement in medicine development. The lessons learned have led to significant improvements in the role of people with conditions, new regulatory approaches to speed up access to life-saving medicines, and a realisation that patient involvement is not a ‘nice-to-have’, it is essential for our healthcare systems.

This framework has led to significant improvements in healthcare, but there is still work to be done to ensure that patient perspectives are fully integrated into regulatory, health policy and access decisions.

Healthcare organisations need to find ways to connect more efficiently and work together to avoid duplication. We need to find ways to engender parity between the clinician and patient communities. The AIDS/HIV epidemic was devastating on so many levels “Who knows what our society would be like today if we hadn’t lost that generation of people,” reflects Neil. Yet, something grew from that devastation that enriches us all today.

As we continue to face the unique challenges that rare diseases present, we can look back on the experiences of patients with HIV and draw strength from their activism and advocacy efforts.

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