Threat for Jim ? (and me)

[Caroline]

Dear Jim,

Can you take a look at this?
LINK REMOVED

I think it is a scary article for you and for me. Look at the line at the end of "commercial", which says:

Quote:

---

Dimethyl fumarate in TECFIDERA has been determined to be a new active substance by the European Medicines Agency's Committee for Medicinal Products for Human Use, which would mean regulatory exclusivity in the EU for ten years (22 November 2013)

The whole article is a type of English that is hard for me to understand, so maybe you can take a look at it and translate it to somewhat more decent english for me.

What I understand of it is that this (secret?) agency, the European Medicines Agency's….. and some (never heard of), is deciding all kinds things behind our backs and what they now seem to decide is that DMF will be a substance that will be exclusively locked to big pharma (won't say their name over here as the bot will find it then).
That's very bad for your Fumaderm, I see coming that it will be replaced for the same but then another name and 20x more expensive, and bad for me, as it will not be allowed anymore to use it over here and produce my medication.

Took a look at the Agency also, they seem to have carefully ruled for themselves, that you only can join, or come in through a long road of connections internally. So there is no public control over this Agency.

Caroline

[jiml]

ok will try to understand I am at the hospital for a scan at the moment reading the article and trying to decipher it will give me something to concentrate on (using their wi fi )

[jiml]

ok will try to understand I am at the hospital for a scan at the moment reading the article and trying to decipher it will give me something to concentrate on (using their wi fi )

I read it much the same as you Caroline, although they only mention their expensive version they have not said they will discontinue my version, and it looks as if they will have exclusive rights to the manufacturing process in the case of your version it is not mentioned and I am not sure who your manufacturer is.
I would think although I am not sure, any existing manufacturing licences would be honoured and as they have a huge market for my version I would not think they would withdraw it.
I am back at the hospital tomorrow to see my Dermo and I will quiz her and see what she knows

[Fred]

I think it is a scary article for you and for me. Look at the line at the end of "commercial", which says: Dimethyl fumarate in TECFIDERA has been determined to be a new active substance by the European Medicines Agency's Committee for Medicinal Products for Human Use, which would mean regulatory exclusivity in the EU for ten years (22 November 2013)

The way I've understood it is this. DMF will still be used by whoever wants to use it as you can't get a world patent on DMF. What you need to look at is the words Dimethyl fumarate IN Tecfidera, so the patent covers the name, the way the capsule is made, what ingredients are in the capsule, but most of all if you look at the patent it states "The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg"

What I understand of it is that this (secret?) agency, the European Medicines Agency's….. and some (never heard of), is deciding all kinds things behind our backs

Took a look at the Agency also, they seem to have carefully ruled for themselves, that you only can join, or come in through a long road of connections internally. So there is no public control over this Agency.

The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. Set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not only reduce the €350 million annual cost drug companies incurred by having to win separate approvals from each member state but also that it would eliminate the protectionist tendencies of states unwilling to approve new drugs that might compete with those already produced by domestic drug companies.

The Management Board is made up of the following members:

• one representative of each of the 28 EU Member States.
  
• two representatives of the European Commission.
  
• two representatives of the European Parliament.
  
• two representatives of patients’ organisations.
  
• one representative of doctors’ organisations.
  
• one representative of veterinarians’ organisations.
  

In addition to the members, the Management Board also has one observer each from Iceland, Liechtenstein and Norway.

The representatives of the Member States, European Commission and European Parliament are appointed directly by the Member State and institution concerned. The four ‘civil society’ Board members (patients', doctors' and veterinarians' representatives) are appointed by the Council of the European Union, after consultation of the European Parliament.

Board members are appointed for a three-year term, which may be renewed.

If you look at their FAQ page it says "This page provides answers to the most frequently asked questions (FAQs) received by the European Medicines Agency. If the answer to your question is not here, please use this form to send a question to the Agency." So you could contact them if you wish

So my conclusion is that your DMF will be fine
Jim's Fumaderm will probably also be ok, however they may decide to remove it to bring in a more expensive version that will make the shareholders richer.

[jiml]

Thanks for that in depth analysis seems Caroline should be ok then, I hope they leave Fumaderm alone as it is a super drug for me. If they do change it it may be something like psorinovo which may be even better.

SEEMS YOU ARE THE SENSIBLE ONE

[Fred]

Thanks for that in depth analysis seems Caroline should be ok then, I hope they leave Fumaderm alone as it is a super drug for me. If they do change it it may be something like psorinovo which may be even better.

SEEMS YOU ARE THE SENSIBLE ONE

I'm no expert and it's just my thoughts, plus TECFIDERA is for MS not psoriasis.

I would think Fumaderm would stay but the reason I said it may go for a more expensive one is that the big pharma Caroline didn't want to mention Biogen Idec who will make Tecfidera also own Fumaderm.

Alert watch out for the Brandwatch Bot paying us a visit now!

I keep telling you I'm sensible, though I doubt Caroline would agree.

[Caroline]

Fred,
Thank you for your, suddenly available sensibility and therefore, excellent analysis. At least this is very hopegiving.
I really was feeling scared for the future, but it seems that probably that is not necessary. I may certainly be writing to the Agency in order to try to have some influence and verification.

Thanks again.
Caroline

[Fred]

Fred,
Thank you for your, suddenly available sensibility and therefore, excellent analysis. At least this is very hopegiving.
I really was feeling scared for the future, but it seems that probably that is not necessary. I may certainly be writing to the Agency in order to try to have some influence and verification.

Thanks again.
Caroline

You're welcome, it was worth it just to get the I will cherish that for the rest of my life.
Oh and Jim please don't get carried away, I don't need another Man Hug thanks.

If you do contact them, I would be interested on how it went.

[jiml]

Oh and Jim please don't get carried away, I don't need another Man Hug thanks.

ARE YOU SURE

[Fred]

Oh and Jim please don't get carried away, I don't need another Man Hug thanks.

ARE YOU SURE

Positive