The following is a guest post from Philip Stevens, Founder and Executive Director of Geneva Network, originally published on their website.
In medicine, the dominance of small-molecule drugs is coming to an end. More future treatments will be biologic – complex drugs with molecular structures many times larger, manufactured inside living structures such as animal cells or bacteria.
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 billions of people.
Despite its transformative potential, research and development (R&D) in medical biotechnology remains concentrated in a handful of countries. The United States by far is the world leader in biotechnological output followed by the United Kingdom, Switzerland, Germany, France and Japan. China has made enormous recent strides and looks set to become a major player in future decades.
The innovative biopharma industry is very much in its infancy in the Gulf region, yet it could play an important role in diversifying away from oil and transitioning towards knowledge-based, more sustainable economic development. Various development plans recognize this, with Saudi Arabia’s Vision 2030 and the UAE’s Dubai Industrial Strategy 2030 and Abu Dhabi Vision 2030 singling out the biopharmaceutical sector as a development priority.
Alongside a robust regulatory environment and adequate R&D infrastructure, an effective intellectual property (IP) system is key to mobilizing the large investments needed to fund risky biotech ventures.
To promote innovation in biologic medicines, the key IP right is not patents but regulatory data protection (RDP), also commonly known as test data exclusivity. For a limited period, RDP 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 this data. In the Middle East, the UAE is taking steps to improve its RDP regime. Other countries in the region are faring less well. Some such as Saudi Arabia have these rules on the statute books, but they can be poorly defined and inconsistently applied. Many Middle Eastern countries provide no protection at all.
This uncertainty about the security of intellectual property rights makes the region a less attractive venue for investment. And without foreign partnerships, local companies will struggle to upgrade their technological capabilities and develop into innovative companies in their own right.
Regulatory data protection explained
Regulatory authorities require data from pre-clinical and clinical trials to be able to approve and certify that a medicine is safe and effective for consumer use before market entry. Clinical trials are painstaking and costly. Estimates of the cost of developing a new medicine range from USD1.2 billion (Office of Health Economics, UK) to USD2.6 billion (Tufts University).
In most sectors companies can protect commercially sensitive data through trade secrecy laws, but the requirement for biopharma companies to disclose data to regulators puts them at a competitive disadvantage.
Susan Finston is co-founder of Indian biomedicine start-up 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”, she says. “But if you are a biopharma innovator, you have to disclose to regulators what your cookbook is.”
RDP 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 is a compelling public interest in regulators having access to the innovators’ test data,” notes Ms. Finston, highlighting the importance of data exclusivity to innovators. “RDP arrangements allow regulators to access that data on the understanding that they will not disclose it”.
Read the full article, including sections on “Clinical test data and biosimilars,” “Why patents aren’t enough,” “The international landscape,” “Does regulatory data protection / test data exclusivity undermine access to medicines?” and the conclusion here.
“Alongside a robust regulatory environment and adequate R&D infrastructure, an effective intellectual property (IP) system is key to mobilizing the large investments needed to fund risky biotech ventures.
To promote innovation in biologic medicines the key IP right is not patents but regulatory data protection...”