Trans Pacific Partnership impacting Vietnamese Pharma industry?

An article titled “How might the TPP impact Vietnamese pharma?” dtd Oct 29, 2015 (http://www.vir.com.vn/how-might-the-tpp-impact-vietnamese-pharma.html) explores how TPP might make the situations difficult for Vietnamese Pharma industry. The article mentions how the stricter Intellectual Property Rights protection clauses may delay the entrance of generic drugs in the Vietnamese market. The result would be higher cost of essential drugs in a country where insurance plans do not have a high reach and drug prices are a sensitive issue. Also, stricter rules regarding data exclusivity, patent linkage and lower patentability criteria would mean less access of data and formulae to generic drugs manufacturers leading to delay in development of generic drugs. What impact will this have on Vietnamese population? Will this be a rise for the insurance companies in Vietnam? Will this impact the Vietnam’s cost of living and consequently take away the benefits of Vietnam’s low costs?

 

TPP Daily Debunk #1: The Most Progressive Trade Agreement Ever

An article in AFL-CIO America’s Unions (November 10, 2015) titled “TPP Daily Debunk #1: The Most Progressive Trade Agreement Ever” (http://www.aflcio.org/Blog/Political-Action-Legislation/TPP-Daily-Debunk-1-The-Most-Progressive-Trade-Agreement-Ever) questions whether the TPP is a progressive agreement or not. The author explains that the 11 members of the TPP will not benefit by a trade deal that permanently locks in increased corporate power and rights. Some of the trade-offs of the agreement is the fact that it creates extreme monopoly rights for global pharmaceutical companies and provides them more power to drive up costs for Medicare and public health programs in all the TPP countries, resulting in higher drug prices. Also the article challenges this commercial deal and the power that it gives to foreign companies, which will take home the taxpayer dollars to compensate for lost expected profits. How will the TPP impact the international trade for members and non-members of the deal? How will the increase in net exports be balanced with the potential decrease of local investment in the US triggered after the TPP?

No increased medicine costs under TPP Agreement

New Zealand will not face increased medicine costs as a result of TPP deal. New Zealand and Australia won’t change their existing policy on biologics as a result of the agreement which has created some negative feedback from American pharmaceutical companies.

New Zealand’s trade minister Groser said that New Zealand will not pay any more for medicines and the cost of subsidy will not go up by a large extent. It will roughly cost $4.5 million in the 1st year to setup the software to provide additional info. And after that $2.5m a year will be the operating costs. Prime Minister John Key was very happy with the deal as he thinks it would give their exporters better access to more that 800 million people with expected financial benefits of NZ$4.7 billion annually.

Fonterra was disappointed by limited gains for dairy in TPPA as several countries refused to remove all blocks to free trade for NZ’s dairy and beef exports. He said TPP was a small but significant step for the sector, and the dairy deal was a long game that would eventually lead to elimination of tariffs on cheese exported to Japan.

Finally, the negotiators agreed on a minimum period of data protection for next-generation biologic drugs of at least 5 years after a deadlock over rights for drug manufacturers. The US had sought 12 years of protection to encourage pharma companies to invest in expensive biological treatments.The outcome is a two-track system with an 8 year protection for biologics and status quo for all other drugs.

Read full report: http://www.stuff.co.nz/national/politics/72688061/no-increased-medicine-costs-under-tppa

Pharmaceutical companies disappointed with TPP deal over Biologics exclusivity on both sides

The Pharmaceutical industry groups have expressed their disappointment over the compromise in the Trans-Pacific Partnership deal on biologics data exclusivity. The deal stumbled over issue of biologics exclusivity, it would either provide 8 years of exclusivity or 5 years of exclusivity + up to 3 years under a regulatory framework for the the 12 countries in the deal.  US and Japan proposed up to 12 years of protection, but others like Australia fear that would delay entry of cheaper substitutes and raise the costs.

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) issued statements of disappointment over the compromise claiming it would prevent industry innovation. BIO President said that the US-proposed 12-year scheme would have fostered innovation and provided access to bio-similars in a reasonable time frame. He added that the failure of other countries to the length similar to that of US will slow development of breakthrough treatments for patients.

On the other side, Doctors without Borders (MSF) and Public Citizen were disappointed that the exclusivity was 8 years rather than five. Public Citizen said that the deal would expand monopoly protections for the pharmaceutical companies at the expense of people’s access to affordable medicines. MSF said that patients and treatment providers are the biggest losers in the TPP.

Both sides will argue their cases over next 90 days before Congress takes the final vote. US trade Representative Michael Froman praised the deal noting that this is the first trade agreement that assures minimum protections for biologics.

Read more: http://www.raps.org/Regulatory-Focus/News/2015/10/05/23325/Final-TPP-Agreement-Draws-Ire-from-Both-Sides-over-Biologics-Exclusivity/#sthash.5UmPWgqU.dpuf

These 5 facts explain the obstacles to the Trans-Pacific Partnership

An article in Time (August 7, 2015) titled “These 5 facts explain the obstacles to the Trans-Pacific Partnership”(http://time.com/3980075/these-5-facts-explain-the-obstacles-to-the-trans-pacific-partnership/) describes the significant sticking points left that have delayed the agreement in regards to the Trans-Pacific Partnership negotiations. The five main points are: the pharmaceutical fight, dairy imports and exports, car controversy impacting the tariffs for the auto industry, trouble with textiles, and the currency manipulation issues. Considering the particular conditions of each of the 12 participant countries, the TPP agreement represents a challenge for these diverse economies. For instance, while dairy accounts for 25% of New Zealand’s exports, imports in Canada currently face a 248.95% tariff considering the relevant influence that dairy farmers hold in the North American country. Will countries find benefits in the TPP agreement that overweight the tradeoffs associated with the proposed standard regulations?

Chile Minister Wants U.S. Concessions in TPP

An article in Bloomberg (August 19, 2015) titled “Chile Minister Wants U.S. Concessions in TPP” (http://www.bna.com/chile-minister-wants-n17179934929/) describes some of the main controversial points for Chile of the Trans Pacific agreement. The principle debated topic has been the length of patents on biological pharmaceuticals. While Chile currently enforces 5 years of patents, the U.S through the TPP agreement is pushing for 12 years protection now reduced to 8 years after the most recent rounds of negotiations. Chile’s legislation requires that the state covers the extremely expensive medical expenses of patients from catastrophic diseases. Therefore a longer period of protection for patents represents higher risks and costs for the South American country. With regards to this discussion, U.S has offered the inclusion of the 3 years of required testing within the 8 years demanded but TPP. Will Chile accept the U.S proposal? Will extending the length of patents incentive innovation and balance the trade-off of the implied costs for the countries with their subsidized health programs?