Kristina Lybecker's blog

All Mixed Up Down Under: Why Australia Should Embrace Robust Regulatory Data Protection in the TPP

Regulatory data protection (RDP) is neither an extension of patent rights nor a substitute for them. Though they work through different avenues, both serve to incentivize biopharmaceutical firms to invest in the research and development that bring us breakthrough therapies and cures. If innovative therapies and improving global public health are important to Australia, they should protect biologic medicines with both robust patents and RDP.

Global Access to Oncology Drugs: Intellectual Property Rights are Key

While strong intellectual property rights (IPRs) are frequently depicted as a barrier to wider access to medicines, evidence suggests that weak intellectual property rights environments are also a barrier to access, discouraging timely product launches. In the current debate over access to medicine, it is essential to recognize that insufficient IP rights also harm patients. Affordable…unaffordable…before price can be an issue, products must be available. As noted by Lanjouw, “Less than one-half of the new pharmaceutical molecules that are marketed worldwide are sold in any given country, and those that are sold are often available to consumers in one country only six or seven years after those in another. Both price regulation and intellectual property rights influence these outcomes.” If cancer patients are to receive the treatments they need, nations must embrace both availability and affordability. Sufficient intellectual property rights protection is key to availability.

Embrace Success: The Case for Data Exclusivity

Intellectual property protection is essential to global health and the future of medicine. In the Trans-Pacific Partnership (TPP) Trade Agreement we have the ability to embrace medical breakthroughs and invest in a healthier future, or to undermine it. The United States is currently negotiating the TPP with eleven other nations (Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam), and intellectual property protection is a contentious issue in the discussions.

How the Canada EU Trade Agreement Benefits All Canadians

Canada and the European Union recently announced the completion of the largest trade agreement in Canada’s history, the Comprehensive Economic and Trade Agreement (CETA).   Importantly, the agreement moves beyond the traditional reduction of tariffs and elimination of non-tariff barriers to close critical gaps that currently exist in intellectual property protections. 

Biopharmaceutical R&D: Investments in Innovation, Jobs, and Economic Development

Innovation is the engine of economic growth and development. Research and development (R&D) spending is what creates jobs and makes innovation a reality. As the global economy continues to recover and regain its former strength, the pharmaceutical industry remains the world’s largest source of R&D spending. According to a recent article in the Wall Street Journal, global pharmaceutical companies expect to spend just over $92 billion on research in 2015. Citing the 38th annual R&D Ratios & Budgets report from Schonfeld & Associates, the article notes that the pharmaceutical industry will spend 40% more than automotive companies which will be the second biggest investors at $65 billion.

Patients need the TPP

Patients will benefit from the Trans-Pacific Partnership, as will the member countries. Protecting intellectual property rights is a critical component and vital to the future treatments that are so desperately needed.

Biopharmaceuticals: Saving Lives and Saving Money

The biopharmaceutical sector invests in research that improves health and lengthens lives. Researchers in the biopharma industry are working on treatments for diseases than range from AIDS to Tuberculosis to West Nile Virus. These medicines improve the quality of our lives and also lower our healthcare bills. Research shows that each dollar increase in pharmaceutical spending yields as reduction in hospital expenses of $3.65.

Economic and Social Benefits of Medical Innovation

Technology is, to a remarkable degree, a local not global asset. Research has established that innovation in high tech industries is enhanced by geographic concentration, which facilitates R&D spillovers. Proximity facilitates collaboration, technological spillovers and enhances innovative productivity. All of these benefits are facilitated by an environment of secure intellectual property rights and safeguards for innovation.

Trade, Innovation and Health

Recent months have seen increasing coverage of the Trans-Pacific Partnership (TPP), and an increasing number of contributions and expert opinions on the value of this agreement. There is growing recognition of the importance of the TPP for America’s innovative industries and the pharmaceutical and biotech industries in particular. These industries provide a telling glimpse of the critical nature of intellectual property (IP) protection to the US economy. The value of IP protection is essential to both public health and safety, as well as US jobs.

Counterfeit Drugs: Definitions Matter, but Not as Much as Quality and Safety

 Dr. Kristina M. Lybecker

The safety and efficacy of medicines is something that most patients in developed countries take for granted.  Whether it’s a vaccination, prescription, or over the counter drug, most people assume that the medicines they’re getting are legitimate.  While bogus drugs are most frequently found in the most vulnerable markets – those of developing nations that all too often lack access to medicines –  this is certainly not always the case. 


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