The Trans-Pacific Partnership Provides Opportunities for Expansion in the Asia Pacific Region


With several new trade agreements aimed to expand and simplify the trade process, there is an unprecedented opportunity for North American pharmaceutical companies to expand their business into emerging markets.

One of the most significant of these opportunities is the Trans-Pacific Partnership (TPP), which if passed, is expected to bring several economic benefits to small and large U.S. businesses and open the door to trade in the Asia Pacific region.

Under negotiation since 2008, the TPP is a free trade agreement involving 12 countries that represent $28.1 trillion or almost 40% of global GDP. The TPP includes; Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.

The agreement aims to:

  • Lower or eliminate tariffs and non-tariff barriers on a variety of products to help large and small businesses sell and export to overseas companies.
  • Provide an investor-state dispute settlement process.
  • Protect intellectual property rights.
  • Synchronize e-commerce including data flows and electronic transaction authentication, as well as intellectual property protections.
  • Streamline supply chain and customs procedures.
  • Create a “living” agreement, which will allow for updates as new trade issues emerge and will enable other countries to be part of TPP.

Businesses with global sourcing can take advantage of liberalized trade to actually benefit on both ends. For example, US manufacturers that depend on TPP sourcing can get the components needed to produce final products at an economical price from TPP countries and then export the goods back to TPP customers.

How will the TPP affect pharmaceutical companies?

The negotiating TPP texts have not been made public and there is wide speculation on what will be included, especially when it comes to the pharmaceutical industry.

While there is much we don’t know about the TPP, reports from the office of the United States trade representative state that the pharmaceutical intellectual property provisions seek to promote innovation and the development of new, lifesaving medicines; create opportunities for generic drug competition and ensure the affordable access to medicines.

The World Trade Organization (WTO) oversees the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an agreement where all participating nations, including the U.S., agree to honor 20-year drug patents. Under TRIPS, countries that can’t afford to manufacture drugs they need are able to acquire a compulsory license, allowing them to bypass another country’s patent and import patented, brand-name drugs at generic drug prices. This means developing countries have access to these medications now.

However, there is speculation that pharmaceutical patents under the TPP could have much stronger protections for drug companies than what is currently in TRIPS. For example, patents could be extended beyond 20 years, essentially delaying when generic drugs go to market.

Although negotiations and speculation of what will be included in the final TPP continue, there are steps pharmaceutical companies can take now to prepare for the TPP and other pending trade pacts.

How to Prepare Now for the TPP

With the unprecedented number of trade pacts and continued globalization of the supply chain, it is vital that businesses seeking to trade remain agile. To do this, businesses need to stay up to date on trade news and understand the opportunities and risks they present to their business.

In advance of TPP passage, businesses seeking to trade with these 12 countries will need to ensure that the trading partners are part of their strategic plans, both for their manufacturing location and component sourcing strategies.

Taking advantage of a trade program means companies must analyze their manufacturing locations and supply chains to those sites.  This analysis requires reliable data, including bills of material, costs and supplier information, as well as subject matter experts who can apply this information to the TPP rules of origin when they are finalized.

Businesses should begin thinking about how to quickly amend their supplier contract terms and conditions to include language regarding participating in and compliance with TPP.

While keeping up to date with these regulations and new agreements can seem daunting, a global trade management business partner can be a company’s trusted advisor and help navigate the trade landscape. It is important to work with foreign suppliers, brokers, and customs experts in advance of making trade preference claims, especially under a new program. A global trade management company will do the data analysis for a company and simplify the trade process.

Increasing ROI for Digital Tactics from the Inside Out


Measuring the ROI of approved digital tools once they are in the marketplace is a hot topic.
 
The quest to generate a high ROI is an ongoing one and metrics to measure success in digital are often debated. What should not be debated, however, is the value of increasing a company’s ‘internal ROI’ when readying digital tools for promotional review. ‘Internal ROI’ reflects the efficient use of time and money spent internally getting digital promotion approved for use in the marketplace.

This is only possible when Marketing and review team members collaborate upstream before a digital tool is even submitted for approval. Perhaps if we spent more time collaborating earlier in the process, we would deliver a higher ROI from the inside out.

[Read more…]

FDA’s Latest ANDA Guidance: Patent Carve Outs Become a Guessing Game


In May 2015, the FDA released is Guidance (Revision 1) on Refuse-to-Receive Standards for Abbreviated New Drug Application (ANDA) submissions, in response to the 2012 Generic Drug User Fee Amendments (GDUFA) that required the FDA to “enhance” these rejection criteria.  A refuse-to-receive decision indicates that the ANDA is not sufficiently complete to permit a substantive review, and results in the forfeiture of the GDUFA fee and potential 180 day exclusivity rights if the applicant is eligible for “first to file” status.  Under the new Guidance, a major deficiency will trigger a refuse-to-receive decision, as will nine or fewer uncorrected minor deficiencies.  In the case of nine or fewer minor deficiencies, the applicant will have seven days to correct the application and, if not remedied within that period of time, the FDA will issue a refuse-to-receive notice, although it may waive this requirement for good cause shown.
[Read more…]

The Importance of Trusted Product Data & Identification Standards


The Importance of Trusted Product Data & Identification Standards
A cornerstone of Pharma Compliance & Track ‘n Trace Solutions

Nearly a decade ago, the experts in emerging technology and global supply chains were hyping the huge opportunity presented by the use of radio-frequency identification (RFID) in the pharmaceutical industry and other major verticals. Simultaneously, we began to see incessant articles and whitepapers on traceability, visibility and the next evolution of the ‘glass pipeline’. Of course, history will tell us that the high cost of silicone and economies of scale needed to operate an RFID enabled supply chain would render most RFID business cases impractical. At that time, using RFID for traceability did not make economic sense.
[Read more…]

Put “Spring Cleaning” on Your Summer Compliance To-Do List


Summer can be the time of laid back, restful behavior, but it is also a perfect time to assess your half-year of progress and clean up what needs to be done for the remainder of 2015. While housekeeping can be a chore, breaking the tasks into small steps done on a regular basis can keep you on top of your cleaning game. With ever-closer FDA scrutiny and new guidelines in effect, the cost of drug development has never been higher. According to a recent study by the Tufts Center for the Study of Drug Development, the cost of new prescription medication development through market approval is $2.6 billion. Contract manufacturing organizations (CMO) can polish their activities in the following compliance areas to make sure they pass that white-glove test and keep costs to a minimum:
[Read more…]

Chained and Locked – Addressing Pharma Supply Chain Security Challenges


When it comes to assessing and addressing security concerns and vulnerabilities in the supply chain, the pharmaceutical industry faces a multitude of challenges. As both the industry and the individual companies within it continue to grow — with a corresponding increase in the size and complexity of individual supply chains — those challenges are only becoming more urgent.
[Read more…]