The new era of biotechnology promises a revolution in how doctors manage disease, offering hope to patients with conditions for which there is currently no treatment. Advances in gene therapy, the development of safer vaccines, precision medicine and superior diagnostics stand to benefit millions.
Despite its transformative potential, research and development (R&D) in medical biotechnology remains concentrated in a handful of countries. The United States is the world leader by far in biotechnological output, followed by the United Kingdom, Switzerland, Germany, France and Japan. Some emerging markets like China have nascent biotech industries, but medical biotech R&D is far from global.
Those countries with strong industries have a robust regulatory environment, adequate R&D infrastructure and an effective intellectual property (IP) system to mobilize the large investment needed to fund risky biotech ventures.
To promote innovation in biologic medicines the key IP right is not patents but regulatory data protection. For a limited period, regulatory data protection prevents competitors from exploiting the data generated in clinical trials by the original drug developer. The most innovative countries in biotechnology all have clear, legally binding rules to protect these data.
Regulatory data protection explained
Regulatory authorities require data from preclinical and clinical trials to be able to approve and certify that a pharmaceutical technology is safe and effective for consumer use before market entry. Clinical trials are painstaking and expensive and add significantly to the cost of developing a new medicine, estimates for which range from USD 1.2 billion (Office of Health Economics, United Kingdom) to USD 2.6 billion (Tufts University, United States).
In most sectors companies can protect commercially sensitive data through trade secrecy laws, but the requirement for biotech companies to disclose data to regulators puts them at a competitive disadvantage, according to Susan Finston, co-founder of Indian biomedicine startup Amrita Therapeutics.
“A typical food and beverage company can hold trade secrets on their recipes and so forth, and they can do that in perpetuity. But if you are a biopharma innovator, you have to disclose to regulators what your ‘cookbook’ is,” she says.
Regulatory data protection is critical for biopharma innovators because it ensures that competitors cannot gain regulatory approval and enter the market on the back of an innovator’s test data before the innovator has had a fair opportunity to recoup the costs of compiling it.
“In industries like biopharma or agritech, there...