TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

After five years of negotiations, the release of the final version of the long awaited trade agreement, known as (TPP) on the Trans-Pacific Partnership, and the concessions made to the United States in the WTO TRIPS (aspects trade in intellectual property rights) agreement announced Friday both offer a new view of the pressing force and bargaining power of the pharmaceutical industry.

TPP

Early last month, a number of issues arose at a time when union business: How old organic exclusivity should be provided as part of TPP, especially for small countries like Malaysia, Vietnam and Singapore, where patients They may suffer if cheaper biosimilars are restricted for longer periods of time?

Sales representatives in the United States and Japan for a longer period of protection - 12 years - in order to protect and encourage new innovations, while others, such as Australia, fears postponing the entry biosimilars for so long that he said would increase costs.

From October leaks text TPP final documents leave some room for how countries should deal exclusively biological, providing five years of exclusivity in some cases with additional provisions and eight in the other case.

And although neither party (groups or non-profit that seeks to expand the use of cheaper drugs the pharmaceutical industry) offered praise for the final decision on market exclusivity, the transaction is clearly a victory for the industry involved in Some countries, such as Brunei and Malaysia, currently don 't offer years of protection organic market, and the US still have their 12 years of protection.

Price Information

Other parts of TPP agreement, which in some cases reflect the position of the United States, new provisions for regulating pharmaceuticals and devices from other countries such as Singapore, Brunei, New Zealand, Chile, Australia, Peru, Vietnam, Malaysia, Mexico add, Canada and Japan.

Some provisions restrict countries to use "sales prices and financial data relating to the marketing of the product" in the context of the decision to approve a particular drug or medical device for a given contract, according to an Annex to Chapter 8 on Technical Barriers to Trade

James Love, director of the NGO Knowledge Ecology International, said: "While there are arguments in favor of the concentration of the drug approval decisions within medical considerations, there is also a lack of information on drug prices , income and other data on the pharmaceutical market economy. Linking marketing authorization to provide reports on these issues should not be prohibited by the TPP ".

In addition, the TPP text adds a provision to keep pharmaceuticals markets in countries where regulators are still returning to authorize their use.

The text states that when the regulatory agency of a country requires periodic reauthorization for a pharmaceutical product that has already received a marketing authorization, the agreement requires countries to "allow the pharmaceutical product to stay on the market under conditions prior approval pending its decision on the periodic reauthorization marketing, unless a Party identifies a safety or health significantly. "

Annexe of transparency also calls on countries to provide medicines and medical device companies more rights to monitor and challenge government decisions on reimbursement of drugs - another victory for the industry.

In addition, multinational pharmaceutical and medical device companies will be happy to see another provision that limits the countries involved in TPP to require a product to be manufactured locally as a condition for approval of a product.

Collaborations Inspection

The TPP agreement could also add new provisions to regulators of medicines and health products in the countries concerned, because the agreement is to improve collaboration in the pharmaceutical inspections.

Under the agreement, regulators would be required to notify a country before conducting an inspection, "unless there is reasonable ground to believe that this could undermine the effectiveness of the inspection." And in some cases, the agreement says that countries should allow representatives of the competent authority of a country to observe the inspection of pharmaceutical manufacturing sites in other countries.

In addition, regulators carry out inspections in other countries would be required to notify the other of the results of inspections "as soon as possible after an inspection and, if the results will be announced at the end of a reasonable time before liberation. "

However, in countries like the United States, which regularly inspects manufacturing facilities abroad, the country of inspection "you are not obliged to notify their conclusions if you think your results are confidential and will not be disclosed."

out of the WTO TRIPS

In addition to the TPP Agreement, the World Trade Organization (WTO) decided on Friday to the world's least developed countries to be exempted from patent rules for 17 years.

The exemptions allow local manufacturers and other international programs to provide the necessary drugs, as HIV treatment in affected countries without having to deal with patent infringement lawsuits.

However, before this agreement 17 years, the European Commission and others have offered their support for an indefinite period exemption for these countries until they cease to be an LDC.

In a statement on the agreement on Friday, MSF, KEI, Public Citizen and others stressed that the indefinite exemption "received the unequivocal support of the almost universal civil society throughout the world, international agencies and the United Nations (WHO, UNDP, UNAIDS, UNITAID) and the European Union declared unanimously by the WTO members, with the exception of the United States. If the Council for TRIPS of the WTO attaches to the least developed countries to their valid claims and wished, it would have shown the world that the WTO take steps to protect the poor and most vulnerable measures. "

The groups also "an urgent appeal to all least developed countries to actively use the political space created this new period of transition and, therefore, must take immediate steps to amend their national laws to exclude protection products and pharmaceutical patents protection of test data with the explicit provisions that would be up to January 1, 2033 or the end of this transition period after which may be granted by the TRIPS Council of the WTO. "