At the start of 2020, our members were focused on continuing their research and development of transformative treatments for the most difficult diseases, such as cell and gene therapies. We planned on making strides on new medicines for chronic diseases like diabetes, heart disease and cancer. And we planned on pushing for policy solutions that would lower patient costs at the pharmacy counter.

Stephen Ubl

The events of the past year have forced us to make room in our plans to address the pressing needs laid bare by the COVID-19 pandemic.

As pharmacists and pharmacy techs pivoted to support patients through these unsettling times, America’s biopharmaceutical companies too have pivoted to rallying on four key fronts to beat this pandemic.

First, we’ve been working to develop and produce diagnostic testing. Our companies have tapped the expertise in their laboratories to supplement state and federal public health authorities.

Second, we’ve repurposed existing medicines to see if they’re effective against the virus. Already, one product, an antiviral previously researched for past public health emergencies like Ebola and MERS, has been FDA-approved and has been shown to shorten the time COVID-19 patients are hospitalized.

Third, we’re developing new medicines, with over 1,600 trials that are testing nearly 500 unique therapies. One such approach involves monoclonal antibodies, two of which, as of this writing, have received emergency use authorization from the FDA. Another approach that involves the direct transfusion of blood plasma from recovered COVID-19 patients to develop immunity in recipients is in clinical trials as well.

And we’re hard at work to develop vaccines. Today, there are more than 40 unique vaccines in clinical trials, with five distinctly different types under study. And at the time of this submission, there are three vaccine candidates that suggest great effectiveness in their safety profile. The high number and variety of candidates being pursued by biopharmaceutical companies increases our chances of seeing successful vaccines come to market as quickly as possible.

All this work is done on behalf of the frontline health care workers like doctors, nurses and pharmacy employees and the high-risk people they serve. The crucial role pharmacies will play in getting Americans vaccinated and our world back to normal will be crucial to this effort.

When the pandemic began in earnest in March, pharmacies had to figure out how to quickly operate safely in this new world while still serving patients. Our companies are doing the same when it comes to vaccines: Just because we’re moving quickly doesn’t mean we’re sacrificing safety. COVID-19 vaccine candidates will be subject to the same regulatory standards as other vaccines and biological products, including testing in Phase 3 trials with tens of thousands of participants from all walks of life. The two most widely reported vaccine candidates from Pfizer and Moderna enrolled over 40,000 and 30,000 participants, respectively.

These vaccines will be subject to the FDA’s rigorous regulatory review and approval process, and they’ll have the same post-approval safety monitoring as other vaccines. And when it comes to manufacturing, the same standards and quality controls will apply.

We are also working with governments and insurers to make sure that when new treatments and vaccines for COVID-19 are approved, they will be available and affordable for patients. Companies have a track record of pricing responsibly during pandemics. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said he is not aware of any situation where companies priced vaccines out of reach in pandemic situations.

While we’re working around the clock to find treatments and vaccines for COVID-19, we haven’t stopped on the other goals we set at the start of the year. In cancer, we have over 1,100 medicines and vaccines in development, with 2020 bringing about innovations and approvals in multiple myeloma, metastatic HER2-positive breast cancer and non-small-cell lung cancer.

Further, our industry has made bold leaps in cell and gene therapies. A 2018 Pharmaceutical Research and Manufacturers of America report on the cell and gene therapy pipeline found 289 therapies in clinical development by biopharmaceutical companies in the United States.

Today that number is 362.

These 362 novel cell and gene therapies range from early to late stages of clinical development and are focused on a variety of diseases and conditions, from cancer to genetic disorders to neurologic conditions. These therapies represent the translation of basic scientific understandings into innovative new treatment options for patients.

We have also not stopped working with policy makers in Congress and in state capitals on solutions that can improve access to medicines without sacrificing innovation.

During this election cycle, rising out-of-pocket costs were a significant concern for many voters, who cited these costs as one of the barriers they face to the care they need. This isn’t news to anyone who works at a pharmacy and sees that the status quo isn’t working for the patients they serve.

Due to negotiations in the market, net prices for brand medicines grew just 1.7% in 2019, less than the rate of inflation. And recent National Health Expenditures data show that spending on retail medicines grew just 2.5% in 2018. But it often doesn’t feel that way for patients because of the high deductibles and co-insurance they have to pay when they go to pick up their medicine.

When nearly half of spending on brand medicines goes to the supply chain and other entities and not the biopharmaceutical companies that research, develop and manufacture the medicines, but patients still can’t afford their out-of-pocket costs, something needs to change.

We’re all concerned about cost. We know that the incredible innovation coming out of our companies only counts if it gets to those who need it most. And we’re offering real solutions that can help patients pay less.

Our industry has been forward leaning, pushing for a real, proactive agenda to help patients better access and afford their medicines. That includes making insurance work like insurance again by fighting for policies that share the more than $175 billion in rebates and discounts given to insurance companies, the government, pharmacy benefit managers and other entities in the supply chain last year, directly with patients at the pharmacy counter.

It includes advocating for reforms that would end the practice of compensating PBMs and other entities in the supply chain based on a percentage of the price of a medicine. Instead, supply chain entities would receive a fixed fee based on the value their services provide.

It includes working to make manufacturer cost-sharing assistance count toward deductibles and other cost-sharing burdens and giving patients more predictable cost-sharing and smoothing their costs over the year so they don’t face a steep payment every January when they come to pick up their medicines at the pharmacy.

It includes working with insurers to develop innovative ways to link payment for medicines to the outcomes they deliver to patients. These arrangements can lower out-of-pocket costs for patients and improve access to medicines.

And it includes fixing programs like 340B, which enable hospitals and others in the supply chain to profit without any assurances that patients see any benefit.

These are meaningful efforts to control health care costs that won’t jeopardize quality and choice the way some other policies, like foreign reference pricing and importation, would do. As we’ve observed, price setting impacts patients in Europe, allowing governments to dictate what medicines are worth, which leads to worse outcomes and less access and slows down research and development. Instead, our goal should be lower costs for patients, improved access and more innovation, not greater government control.

As we head into a new year, I’m confident that we will beat COVID-19 and get back on the road to normal. A lot of that confidence comes from how collaborative our efforts have been. From the frontline workers at the hospitals who are treating patients, to the pharmacy workers who are administering flu vaccines and tests for the virus and providing medicines for complications from the disease, to researchers who are looking for treatments and vaccines, we’re coming together to help our country get through this difficult crisis.

My hope is that in 2021, we can bring that same collaborative effort to really getting to the root of the issue of patient affordability and working together on policies that support patients.

Stephen Ubl is the president and chief executive officer of the Pharmaceutical Research and Manufacturers of America.