Negotiators from 11 countries have been racing to resurrect the near-dead Trans-Pacific Partnership Agreement before the Asia-Pacific Economic Cooperation (APEC) summit this weekend.
The latest plan to get the controversial trade deal up and running again after the withdrawal of the United States involves freezing some of its controversial rules. These include rules for biologic drugs, an expensive class of medicines often used to treat conditions such as cancer and rheumatoid arthritis.
Read more – Explainer: what are biologics and biosimilars?
The market monopoly
Biologic drugs are produced from living organisms using certain types of cells to produce particular proteins. Biologics have the ability to bind to specific cells, which means they are often more effective and may have fewer side effects than broadly acting drugs.
They are very expensive, particularly when they are under monopoly protection. This is when the drugs can’t be legally copied for a certain amount of time. Governments have accepted the pharmaceutical industry’s proposition that they need this monopoly period to recoup their research and development costs.
For example, pembrolizumab (Keytruda), a drug for metastatic melanoma, cost patients approximately A$150,000 for a year’s treatment before it was subsidised by Australia’s Pharmaceutical Benefits Scheme (PBS).
Once the period of monopoly protection ends, biosimilar medicines (generic versions) can be produced and sold at lower prices. Currently in Australia, once a biosimilar is on the market and listed on the PBS the market prices will drop by about 16% for all brands of the medicine.
Disagreement over the period of monopoly protection for new biologic drugs once brought the negotiations over the Trans-Pacific Partnership (TPP) agreement to a standstill. The final text of the TPP, negotiated before the withdrawal of the United States, includes a controversial provision for monopoly protection for biologics known as data exclusivity.
During the period of data exclusivity, other drug manufacturers wanting to replicate the medicine can’t access the clinical trial data used to demonstrate the safety and efficacy of the original drug to the regulator.
This form of monopoly protection is separate to the period of patent protection. In Australia, the data protection period is currently five years for both biologics and conventional drugs.
Read more: Why biologics were such a big deal in the Trans Pacific Partnership
The final TPP text, pushed by the United States, requires countries who ratify the agreement to provide for eight years of data exclusivity. Or alternatively five years of data exclusivity together with other (unspecified) measures that would still grant the original drug manufacturer a monopoly over the market.
While the industry argues this period is necessary to support innovation, there’s little evidence to validate this claim. One international comparative study found no relationship between the existence of data exclusivity and the amount of pharmaceutical industry investment in a country.
Two reviews commissioned by the Australian government found no evidence exclusivity for biologic products need be extended.