Thursday, 26 January 2012

What about some "Regulatory affairs in the US and EU" - Part V of X

Preface: Welcome to the very middle of this review when the 5th out of 10 modules of PTI's course on Regulatory Affairs in the European Union and the United States is observed briefly evaluated regarding content, curious facts, missing parts, etc, through the observing eye of someone who paid from his own pocket to, once upon a time, improve his employability. And to celebrate the fact that PTI were kind enough to just post me a beautiful certificate, I will today share that personal accomplishement in my life and offer you guys a very summarised, yet focused analytical review on this 5th module. And to give you guys a good break we save the next 5 modules for the coming week, is that all right?? Good!

Expect a very interesting module I even spent hours discussing with friends of mine! It is a good module for a science round table, hot wedges and a few pints!!!

What is reviewed in the fifth module?

Module five goes through the crucial area of Intelectual Property (law, types of,  and the rights of the generator of pharmaceutical products. It also covers areas like supplementary protection certificates (SPC) and patent restoration; and concludes with the covering of parallel trading of products between countries.

What about funny and curious facts revealed in this module?

- You can learn immediately what a generic is. Not that someone looking forward to work in this area wouldn't know it prior to even start the course, but the author helps by bringing the subject to the discussion table (e.g., Viagra is but sildenafil citrate).

- It can happen that a generic product may not be sold on a determined market when market exclusivity is still valid, thus protecting the product innovator.

- The UK generic market is one of the lowest priced in the EU, however it is also slow in selecting and accepting new products.

- In the United States a patent rules out only after 20 years of being submitted and 17 years of being approved, whereas in the European Union there is an advantage of, when accepted, a patent is therefore provided by the European Patent Office and made present in every single region of EU (big disadvantage being the different lifespan of patents in each country).

- It is so interesting to learn about the market strategies adopted by companies to even tackle the loss of profit cause by generics forcing them to battle their own patents with generics of that kind!!!!!!!

- Patent challenging is covered with highlights of the explosive Ranbaxy versus Pfizer case. Also a past conflict between Roche and Bolar is exposed.

What about some awesome quality information?

We get to learn about the influences and "jurisdictions" of the Pharmaceutical Price Regulation Scheme as well as the Drug Tariff on determining the price of pharmaceuticals.

When applying for a generic to be accepted in the UK market, bioequivalence is the level to reach, i.e., proving that the "product delivers the same level of active ingredient within the patient’s body at the same time as the originator’s branded product".

- The explanation of the 9+2+1 system is GOLD!

- Up to 80% of drugs sold online are counterfeit (Jesus Christ!!!!!! I had no idea!!!!).

Is there anything missing?

It is not the goal of the present course, but further analysis to the importance and even capacities within the EU patent harmonisation talks binding all Member States to the 21 years idea would be welcomed.

I think a brief glossary would be a plus in this course. I mean, for the sake of the example, when the student is looking for the definition of Paragraph IV Certification, Drug Master File and the like.

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