The 12 Pacific Rim nations that had been engaged in long-drawn negotiations to effect the Trans-Pacific Partnership (TPP) finally reached a consensus in early October 2015. The TPP—when it is officially effected in early 2016—will be the largest free-trade agreement to date and will cover a third of all global trade.

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Although the deal is aimed at reducing trade barriers between the partners and to create a common intellectual property framework, it has received criticism for being secretive and skewed in favor of the wealthier nations. And now, there are added concerns that the TPP could also deprive the poorer nations that are a part of this agreement from gaining timely and affordable access to biological drugs.

Why are Biological Drugs so Important?

The high economic burden of chronic non-communicable disorders has prompted both public healthcare agencies and private pharmaceutical companies to fire the engines in developing biological drugs. The World Health Organization (WHO) states that about 60% of the 56.4 million deaths worldwide in 2001 resulted from chronic diseases. Chronic diseases alone accounted for 46% of the global disease burden, and this figure is expected to rise considerably to 57% by 2020, the WHO says.

The rising incidence of chronic diseases worldwide will lead to an intensified focus on developing biological drugs thanks to their advantages over non-biological drugs. Transparency Market Research says in its latest report that the growing burden of chronic diseases will largely stimulate growth in the global biological drugs market, which is projected to exceed US$287.1 bn by 2020. However, the high cost of biological drugs is the greatest impediment to the growth of the market.

How will the TPP Prevent Poorer Nations from Gaining Access to Biological Drugs?

Biological drug development calls for massive amounts of time, money, and expertise. The Brookings Institution, a not-for-profit organization that conducts independent research on policy decisions, states that the cost of making structurally complex biological drugs is about 22 times more than comparable small-molecule drugs. The high cost of developing biologics naturally adds to their market price. This has resulted in a parallel ‘biosimilars’ market.
As the name suggests, biosimilars are more affordable ‘copies’ of the generic drugs and are thus more readily purchased by consumers. Understandably, companies that spend several years and millions of dollars in developing biological drugs have been lobbying hard to prevent competitors from replicating their formulas and developing counterfeit products. This lobbying has paid off in several countries where governments now grant data exclusivity to manufacturers of biological drugs. This data exclusivity prevents drug regulation authorities from approving biosimilars for a set number of years. In the United States, for instance, biologics enjoy a 12-year data exclusivity period.

However, this is also where disparate data exclusivity timeframes come into the picture. Poorer countries such as Brunei, for example, have no data exclusivity period at all. To ensure that the TPP doesn’t compromise the stronghold of large U.S.-based pharmaceutical companies, the U.S. has been pushing hard to have every country in the TPP agreement sign a biologics data exclusivity clause. All parties concerned have finally agreed to sign a data exclusivity clause, which reportedly ranges between five to eight years.

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Healthcare experts and activists feel that data exclusivity will delay the introduction of biosimilars into several nations. The ramifications of this will be more severe in poorer nations where patients simply wouldn’t be able to afford expensive biological drugs and will lose out on effective therapies. Thus, the already pressing concern of prohibitively expensive biological drugs will be exacerbated by the Trans-Pacific Partnership.

Thus, unless a fair biologics data exclusivity period is granted to poorer countries who are a part of the TPP, patients here are at risk of missing out on life-saving medicines.

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