Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 07 August 2017 | By Zachary Brennan
As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products.
"These challenges hinder or prevent innovators from securing patents (patent backlogs and restrictive patentability criteria), maintaining and effectively enforcing patents (compulsory licensing, and weak patent enforcement) and protecting regulatory test data (regulatory data protection failures)," the report, signed by BIO SVP of international affairs Joseph Damond, says.
Regulatory data protection (RDP), which BIO says is "particularly critical for biologic medicines," provides for the temporary protection of the package of information biopharmaceutical companies submit to regulators to demonstrate the safety and efficacy of a medicine.
"Unfortunately, many US trading partners do not provide adequate, if any, RDP. This is clearly contrary to WTO rules, which require parties to protect regulatory test data against both disclosure and unfair commercial use," BIO says.
For instance, BIO notes that some countries, like Algeria, do not provide such protections for regulatory data, meaning pharmaceutical products can receive marketing approval but "leave innovators subject to unfair use of their data that can result in unfair early entry of follow-on products."
Similarly, governments have issued or threatened to issue compulsory licenses, which allow local companies to make, use, sell or import particular patented medicines without the consent of the patent holder.
"In the case of medicines, BIO strongly believes governments should grant CLs only in accordance with international rules and only in exceptional circumstances and as a last resort," the report says, highlighting the 2012 example of Bayer’s Nexavar (sorafenib) in India, though other recent "attempts to secure CLs were made after the Sorafenib decision but no additional CLs have yet been granted."
Similar to that example, BIO also highlights the 2012 decree issued in Indonesia authorizing government use of patents for nine patented pharmaceuticals.
"The indiscriminate use of compulsory licenses draws investment away from the biotechnology sector that is heavily reliant on patents to generate investment funding," BIO said.
The industry group also takes issue with Brazilian law, which establishes that the regulatory authority, known as ANVISA, must provide prior consent on the grant of a pharmaceutical patent before the country’s National Industrial Property Institute (INPI) issues a patent.
"ANVISA has interpreted this requirement as an obligation to review patentability criteria (novelty, nonobviousness, and utility)," BIO says, advising that such reviews "should not, under any circumstance, review patentability requirements since this is a function that is squarely and solely within the purview of the INPI."
Similarly, BIO takes issue with Canada’s Patented Medicines Review Board (PMPRB), which "has jurisdiction over ex-factory pricing of patented drugs and routinely imposes significant price controls."
In addition, the PMPRB asserts jurisdiction over circumstances "where there is even the slightest tenuous relation (a ‘mere slender thread’, as the courts have put it) between the patent and the product, e.g. a patented container technology that is not used-- but could someday be used-- for a patented medicine. The result is that price controls are imposed on unpatented medicines because patents exist that ‘pertain to’ them but do not cover them."
Meanwhile, in China, BIO notes that the patent examination backlog and regulatory review delays at the China Food and Drug Administration (CFDA) "significantly curtail the effective rights of IP owners."
While calling the current system for preventing the approval and sale of infringing drugs in China "fairly ineffective," BIO says CFDA’s more recent priority review policy, which can provides accelerated regulatory review and approval to applications that meet "urgent and unmet medical needs," China has yet to provide a definition for "urgent and unmet medical needs."
BIO also says it has "significant concerns" regarding CFDA’s proposal to create a drug price ceiling in order to receive regulatory approval, adding that maintaining regulatory assessments independent of pricing considerations "is crucial to ensuring that drugs and biologics reaching the market are evaluated objectively against evidence-based clinical and scientific standards for safety and efficacy."
BIO further raises serious concerns about China as the world’s top manufacturer of pharmaceutical ingredients, as such manufacturers of bulk chemicals that can be used as active pharmaceutical ingredients (APIs) are required to register with CFDA if the product manufactured is intended for use in medicinal products.
"However, if a company manufacturers a bulk chemical that can potentially be used as an API, but does not intend or declare that the bulk chemical will be used in a finished pharmaceutical product, then CFDA would not serve as the competent authority," BIO notes. "Furthermore, Chinese manufacturers that only export their products are not subject to regulatory oversight or review."
BIOTECHNOLOGY INNOVATION ORGANIZATION 2017 SPECIAL 301 SUBMISSION
Tags: intellectual property BIO, biopharmaceutical patents, ANVISA, IP protections
Regulatory Focus newsletters
All the biggest regulatory news and happenings.